Re: FDA - Xolair Safety Review

[Guest guest]

Not good news. Not good at all. I hope this is being overhyped.

-----Original Message-----

From: danielpercy <groups@...>

Sent: Thu, Jul 16, 2009 4:30 pm

Subject: [ ] FDA - Xolair Safety Review

Just had this pop up in my news feeds - as somebody receiving Xolair

off-label for my urticaria, I really don't know what to do...

---------------------------

Early Communication about an Ongoing Safety Review of Omalizumab

(marketed as Xolair)

7/16/2009

FDA is evaluating interim safety findings from an ongoing study of

Xolair (omalizumab) that suggests an increased number of cardiovascular

and cerebrovascular adverse events in a group of patients using Xolair

compared to a group of patients not given the drug (control group).

Xolair is approved for use by adults and adolescents (12 years of age

and above) with moderate to severe persistent asthma who test positive

for reactivity to a perennial airborne allergen, and whose symptoms are

inadequately controlled with inhaled corticosteroids.

The ongoing study, titled Evaluating the Clinical Effectiveness and

Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS),

is an observational study of approximately 5000 Xolair treated patients

and a control group of approximately 2500 non-Xolair treated patients.

The primary objective of the EXCELS study is to assess the long-term

safety profile of Xolair in patients followed for 5 years. Study

patients are 12 years of age and older with moderate to severe

persistent asthma and who have a positive skin test or blood test for

an aeroallergen.

The interim data, submitted by the manufacturer of Xolair (Genentech),

suggests a disproportionate increase in ischemic heart disease,

arrhythmias, cardiomyopathy and cardiac failure, pulmonary

hypertension, cerebrovascular disorders, and embolic, thrombotic and

thrombophlebitic events in patients treated with Xolair compared to the

control group of patients not given the drug.

FDA is not recommending any changes to the prescribing information for

Xolair and is not advising patients to stop taking Xolair at this time.

Until the evaluation of the EXCELS study is completed, healthcare

providers and patients should be aware of the risks and benefits

described in the prescribing information, as well as the new

information from the ongoing EXCELS study that may suggest a risk of

cardiovascular and cerebrovascular adverse events.

This early communication is in keeping with FDA's commitment to inform

the public about ongoing safety reviews of drugs. FDA has not made any

conclusions regarding these data. The Agency is working with Genentech

to obtain further information and will continue to review the strengths

and limitations of these interim results. For example, since EXCELS is

an observational study, there could be differences in underlying risk

factors for cardiovascular and cerebrovascular events between the two

study groups. The Agency will communicate any new findings when its

analysis of the interim safety data is complete. The EXCELS study is

ongoing and final results are not expected until 2012.

The FDA urges both healthcare professionals and patients to report side

effects from the use of omalizumab to the FDA's MedWatch Adverse Event

Reporting program either online, by regular mail or by fax, using the

contact information at the bottom of this page.

This information reflects FDA's current analysis of available data

concerning these drugs. Posting this information does not mean that FDA

has concluded there is a causal relationship between the drug products

and the emerging safety issue. Nor does it mean that FDA is advising

health care professionals to discontinue prescribing these products.

FDA is considering, but has not reached a conclusion about whether this

information warrants any regulatory action. FDA intends to update this

document when additional information or analyses become available.

[Guest guest]

My mom just sent this to me. SHe doesn't know htat I've just been to a

cardiologist trying to figure out the source of a mysterious arrhythmia.

Fortunately, the arrhythmia isn't hindering my heart right now nor is there any

sign of other heart disease, but I hope it isn't Xolair.

Oh crap.

--Kitty

>

> Just had this pop up in my news feeds - as somebody receiving Xolair off-label

for my urticaria, I really don't know what to do...

>

> ---------------------------

>

> Early Communication about an Ongoing Safety Review of Omalizumab (marketed as

Xolair)

>

> 7/16/2009

>

> FDA is evaluating interim safety findings from an ongoing study of Xolair

(omalizumab) that suggests an increased number of cardiovascular and

cerebrovascular adverse events in a group of patients using Xolair compared to a

group of patients not given the drug (control group).

>

> Xolair is approved for use by adults and adolescents (12 years of age and

above) with moderate to severe persistent asthma who test positive for

reactivity to a perennial airborne allergen, and whose symptoms are inadequately

controlled with inhaled corticosteroids.

>

> The ongoing study, titled Evaluating the Clinical Effectiveness and Long-Term

Safety in Patients with Moderate to Severe Asthma (EXCELS), is an observational

study of approximately 5000 Xolair treated patients and a control group of

approximately 2500 non-Xolair treated patients. The primary objective of the

EXCELS study is to assess the long-term safety profile of Xolair in patients

followed for 5 years. Study patients are 12 years of age and older with moderate

to severe persistent asthma and who have a positive skin test or blood test for

an aeroallergen.

>

> The interim data, submitted by the manufacturer of Xolair (Genentech),

suggests a disproportionate increase in ischemic heart disease, arrhythmias,

cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular

disorders, and embolic, thrombotic and thrombophlebitic events in patients

treated with Xolair compared to the control group of patients not given the

drug.

>

> FDA is not recommending any changes to the prescribing information for Xolair

and is not advising patients to stop taking Xolair at this time. Until the

evaluation of the EXCELS study is completed, healthcare providers and patients

should be aware of the risks and benefits described in the prescribing

information, as well as the new information from the ongoing EXCELS study that

may suggest a risk of cardiovascular and cerebrovascular adverse events.

>

> This early communication is in keeping with FDA's commitment to inform the

public about ongoing safety reviews of drugs. FDA has not made any conclusions

regarding these data. The Agency is working with Genentech to obtain further

information and will continue to review the strengths and limitations of these

interim results. For example, since EXCELS is an observational study, there

could be differences in underlying risk factors for cardiovascular and

cerebrovascular events between the two study groups. The Agency will communicate

any new findings when its analysis of the interim safety data is complete. The

EXCELS study is ongoing and final results are not expected until 2012.

>

> The FDA urges both healthcare professionals and patients to report side

effects from the use of omalizumab to the FDA's MedWatch Adverse Event Reporting

program either online, by regular mail or by fax, using the contact information

at the bottom of this page.

>

> This information reflects FDA's current analysis of available data concerning

these drugs. Posting this information does not mean that FDA has concluded there

is a causal relationship between the drug products and the emerging safety

issue. Nor does it mean that FDA is advising health care professionals to

discontinue prescribing these products. FDA is considering, but has not reached

a conclusion about whether this information warrants any regulatory action. FDA

intends to update this document when additional information or analyses become

available.

>

[Guest guest]

ugg, please know with any medication there are risk,one study says your

cool, next your deaths door. So please be your own health advocate. Just my

two cents.. now going back to the corner with my xolair shot..lol

**************Snoop, Lil Wayne, Lady GaGa -- land the tix you need for this

summer's biggest tours. Tourtracker.com

(http://www.tourtracker.com/?ncid=emlcntusmusi00000007)

[Guest guest]

Yikes, this is new to me. But it is only one study and I don't know if other

risk factors were taken into account. I remember reading about Xolair when it

first came out and there was an increased incidence among monkeys (not sure if

they were monkeys or humans studied) taking Xolair getting some

" thrombocytopenia(???) " or a platelet problem. It was a very, very small

incidence, though.

But I think, my opinion only, for my situation that the benefits probably

outweigh the potential risks. It's better to keep my airways open with Xolair

then not have that option. (The potential side

effects/diseases/conditions/illnesses listed in this study do look horrible,

though. )

>

> Just had this pop up in my news feeds - as somebody receiving Xolair off-label

for my urticaria, I really don't know what to do...

>

> ---------------------------

>

> Early Communication about an Ongoing Safety Review of Omalizumab (marketed as

Xolair)

>

> 7/16/2009

>

> FDA is evaluating interim safety findings from an ongoing study of Xolair

(omalizumab) that suggests an increased number of cardiovascular and

cerebrovascular adverse events in a group of patients using Xolair compared to a

group of patients not given the drug (control group).

>

> Xolair is approved for use by adults and adolescents (12 years of age and

above) with moderate to severe persistent asthma who test positive for

reactivity to a perennial airborne allergen, and whose symptoms are inadequately

controlled with inhaled corticosteroids.

>

> The ongoing study, titled Evaluating the Clinical Effectiveness and Long-Term

Safety in Patients with Moderate to Severe Asthma (EXCELS), is an observational

study of approximately 5000 Xolair treated patients and a control group of

approximately 2500 non-Xolair treated patients. The primary objective of the

EXCELS study is to assess the long-term safety profile of Xolair in patients

followed for 5 years. Study patients are 12 years of age and older with moderate

to severe persistent asthma and who have a positive skin test or blood test for

an aeroallergen.

>

> The interim data, submitted by the manufacturer of Xolair (Genentech),

suggests a disproportionate increase in ischemic heart disease, arrhythmias,

cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular

disorders, and embolic, thrombotic and thrombophlebitic events in patients

treated with Xolair compared to the control group of patients not given the

drug.

>

> FDA is not recommending any changes to the prescribing information for Xolair

and is not advising patients to stop taking Xolair at this time. Until the

evaluation of the EXCELS study is completed, healthcare providers and patients

should be aware of the risks and benefits described in the prescribing

information, as well as the new information from the ongoing EXCELS study that

may suggest a risk of cardiovascular and cerebrovascular adverse events.

>

> This early communication is in keeping with FDA's commitment to inform the

public about ongoing safety reviews of drugs. FDA has not made any conclusions

regarding these data. The Agency is working with Genentech to obtain further

information and will continue to review the strengths and limitations of these

interim results. For example, since EXCELS is an observational study, there

could be differences in underlying risk factors for cardiovascular and

cerebrovascular events between the two study groups. The Agency will communicate

any new findings when its analysis of the interim safety data is complete. The

EXCELS study is ongoing and final results are not expected until 2012.

>

> The FDA urges both healthcare professionals and patients to report side

effects from the use of omalizumab to the FDA's MedWatch Adverse Event Reporting

program either online, by regular mail or by fax, using the contact information

at the bottom of this page.

>

> This information reflects FDA's current analysis of available data concerning

these drugs. Posting this information does not mean that FDA has concluded there

is a causal relationship between the drug products and the emerging safety

issue. Nor does it mean that FDA is advising health care professionals to

discontinue prescribing these products. FDA is considering, but has not reached

a conclusion about whether this information warrants any regulatory action. FDA

intends to update this document when additional information or analyses become

available.

>

[Guest guest]

My blood pressure went up tremendously while on Xolair especially when I went to

the infusion center (first and last time - had been a happy home injector before

that) but I wrote off part of that to the nasty place and circumstances. I was

on Xolair 1 - 1/2 years and it helped quite a bit for a year with asthma. Never

could get off other asthma meds but was better. Ultimately, my last PFT was

worse than pre-Xolair. My pulmo, after I complained about difficulty breathing

and severe dizziness and general malaise for hours after PFTs (while on Xolair)

suggested it might have something to do with my heart. I think she was sooo

right! And I think Xolair had some influence but how much I don't know.

Nothing has ever been done about it. The odd heart sensations of possibly an

irregular beat or beating too much also increased.

On the other hand, not being able to breathe right must have some influence on

the heart, right? Presumably heart and lungs affect each other? I'm not

getting any really straight answers because I think all this is a little bit of

a hot potato and still being sorted out.

Xolair did eventually help enormously with the sinus headaches (I'd say 80%

improvement) and at long last I could prove they were **not** " chronic daily

headaches " or " cluster headaches " or " migraine headaches " or " stress headaches. "

That was a psychological relief (doctors were not much use to me re headaches)

for me. Unfortunately, they came right back after I stopped Xolair.

It would be very interesting to find out how and why Xolair caused an increase

in cardiovascular events and strokes. Perhaps some people should not be on it

and others should be monitored closely re these events while on it and even

after it. I wish this kind of stuff was more in the open.

>

> FWIW, I never had blood pressure problems until I started Xolair.

>

> Though at 40, " all hell can break loose " with cardiac issues.

>

> It would be hard to pin point if Xolair was the cause.

>

> I wonder if the cardiac stuff is temporary or permanent?

>

> How come none of this was bought up originally? I would have never been a

candidate for Xolair with family history of severe cardiac issues.

>

> It will be interesting to see how it all shakes out.

>

> Nan

> Sent from my Verizon Wireless BlackBerry

>

[Guest guest]

Thank you to everyone who has posted on this new topic

I am glad the FDA is out there protecting our interests and have published this

finding for us to contemplate.

I have been on xolair since September 2003. Since then, I have had no problems

whatsoever with my heart or anything else. In fact, since Xolair has taken my

need for Prednisone away, I have become much more healthy.

Prednisone was slowly killing me. My C-spine was deteriorating, I developed Type

II Diabetes and my A1C was 9.5. My blood pressure was getting to the point of

needing medication. I was becoming grossly overweight and having medical

problems from that too. Thanks to Prednisone, these are proven heart attack

risks.

Now, that I am on Xolair and completely OFF Prednsione, my A1C is 5.9, I have

lost 30 pounds my c-spine (after 2 fusion surgeries) shows no more sign of

deterioration. I am no longer on my doctor's list to put me on bp medicine and I

really feel GREAT!

For me, this new report gives me a new " risk vs. benefit " to personally look at

like I did the " black box " report a few years ago.

I have come to the conclusion that the benefits do outweigh the risks in my own

personal case and I will continue to take Xolair.

Your personal situation might be completely different. If you are extremely

concerned about all the side effects and FDA reports, you need to share this

with your doctor. You still have the right to refuse Xolair if you wish.

I always have something positive to say about Xolair and have had some group

members ask if I worked for Novartis. The answer is NO LOL!

I wish they WOULD put me on the payroll LOL! I sure could use a few more

buckaroos LOL

I am just one of many people who has had great success with this medication.

Happy Breathing

Doug

Group founder

[Guest guest]

>

> Hey

> How much Prednisone were you on beforehand and how long did it take for you to

taper off it>

> I have many Prednisone complications--cushings, some hbp, diabetes II,

lipomas, etc. 

> Leigh

>

Leigh,

50 mg a day for a few years. It took Xolair a year to kick in and then the doc

tapered me down slowly.

Doug

[Guest guest]

I would like to second Doug's earlier email and clarify that I do not have bone

loss from Xolair...I just can't proofread my own work; I have bone loss

(including in my teeth) from all the years of prednisone!!!! Duh.

I would also like to add that it is critical that asthmatics control their

asthma; lack of oxygen (acute or chronic) can cause organ damage and damage

important bodily systems - more so than 90-95% of the meds out there.

I have a number of questions I'd like to have answered about that study before I

would consider not taking Xolair.

Thanks y'all!

Addy

Group co-owner

> >

> > Hey

> > How much Prednisone were you on beforehand and how long did it take for you

to taper off it>

> > I have many Prednisone complications--cushings, some hbp, diabetes II,

lipomas, etc. 

> > Leigh

> >

>

>

>

> Leigh,

>

> 50 mg a day for a few years. It took Xolair a year to kick in and then the doc

tapered me down slowly.

>

> Doug

>

[Guest guest]

This is scary to me. I have serious side effects from prednisone. It

stunted my growth as a kid, I have very little hair on my body (which I do

say is nice in the summer because I rarely shave my legs), I have a

dowenger's hump on my back (since grade school) and issues with degenerative

disk disease in my spine. This winter was the first time I haven't had to

use prednisone since I can remember. Last winter was so bad that I was on

it from January to April. I guess I am lucky that I don't take it on a

daily basis, like I did as a child, but I am seriously over weight. Every

time I was on the stuff, I would gain 10 pounds or more. During the summer,

I may be able to take off 5 of it, if I was lucky.

Last year, I had an issue with my heart. I had an SVT attack where my heart

was beating 220bpm. I nearly died. We discovered that it was due to the

fact my Bi-pap (yes, I have sleep apnea too) was not set properly after

being serviced. I went through all the cardiac tests they could put me

through and other than a little leakage in my aorta, I am ok. But I suffer

with high blood pressure and worry about this news. I have been

experiencing palpatations or skipping. Now I wonder if it isn't the Xolair.

I finally find something that gets me away from the dependence on steriods

and now I have to worry about my heart - again. I would really like to know

how this medication would cause these things. Maybe a better explanation on

how it works in the body might help me to understand.

Kim

On Thu, Jul 16, 2009 at 3:30 PM, danielpercy <groups@...>wrote:

>

>

> Just had this pop up in my news feeds - as somebody receiving Xolair

> off-label for my urticaria, I really don't know what to do...

>

> ---------------------------

>

> Early Communication about an Ongoing Safety Review of Omalizumab (marketed

> as Xolair)

>

> 7/16/2009

>

> FDA is evaluating interim safety findings from an ongoing study of Xolair

> (omalizumab) that suggests an increased number of cardiovascular and

> cerebrovascular adverse events in a group of patients using Xolair compared

> to a group of patients not given the drug (control group).

>

> Xolair is approved for use by adults and adolescents (12 years of age and

> above) with moderate to severe persistent asthma who test positive for

> reactivity to a perennial airborne allergen, and whose symptoms are

> inadequately controlled with inhaled corticosteroids.

>

> The ongoing study, titled Evaluating the Clinical Effectiveness and

> Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS), is an

> observational study of approximately 5000 Xolair treated patients and a

> control group of approximately 2500 non-Xolair treated patients. The primary

> objective of the EXCELS study is to assess the long-term safety profile of

> Xolair in patients followed for 5 years. Study patients are 12 years of age

> and older with moderate to severe persistent asthma and who have a positive

> skin test or blood test for an aeroallergen.

>

> The interim data, submitted by the manufacturer of Xolair (Genentech),

> suggests a disproportionate increase in ischemic heart disease, arrhythmias,

> cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular

> disorders, and embolic, thrombotic and thrombophlebitic events in patients

> treated with Xolair compared to the control group of patients not given the

> drug.

>

> FDA is not recommending any changes to the prescribing information for

> Xolair and is not advising patients to stop taking Xolair at this time.

> Until the evaluation of the EXCELS study is completed, healthcare providers

> and patients should be aware of the risks and benefits described in the

> prescribing information, as well as the new information from the ongoing

> EXCELS study that may suggest a risk of cardiovascular and cerebrovascular

> adverse events.

>

> This early communication is in keeping with FDA's commitment to inform the

> public about ongoing safety reviews of drugs. FDA has not made any

> conclusions regarding these data. The Agency is working with Genentech to

> obtain further information and will continue to review the strengths and

> limitations of these interim results. For example, since EXCELS is an

> observational study, there could be differences in underlying risk factors

> for cardiovascular and cerebrovascular events between the two study groups.

> The Agency will communicate any new findings when its analysis of the

> interim safety data is complete. The EXCELS study is ongoing and final

> results are not expected until 2012.

>

> The FDA urges both healthcare professionals and patients to report side

> effects from the use of omalizumab to the FDA's MedWatch Adverse Event

> Reporting program either online, by regular mail or by fax, using the

> contact information at the bottom of this page.

>

> This information reflects FDA's current analysis of available data

> concerning these drugs. Posting this information does not mean that FDA has

> concluded there is a causal relationship between the drug products and the

> emerging safety issue. Nor does it mean that FDA is advising health care

> professionals to discontinue prescribing these products. FDA is considering,

> but has not reached a conclusion about whether this information warrants any

> regulatory action. FDA intends to update this document when additional

> information or analyses become available.

>

>

>

--

From the abundance of the heart the mouth speaks. - Prince

[Guest guest]

>

> This is scary to me. I have serious side effects from prednisone. It

> stunted my growth as a kid, I have very little hair on my body (which I do

> say is nice in the summer because I rarely shave my legs), I have a

> dowenger's hump on my back (since grade school) and issues with degenerative

> disk disease in my spine. This winter was the first time I haven't had to

> use prednisone since I can remember. Last winter was so bad that I was on

> it from January to April. I guess I am lucky that I don't take it on a

> daily basis, like I did as a child, but I am seriously over weight. Every

> time I was on the stuff, I would gain 10 pounds or more. During the summer,

> I may be able to take off 5 of it, if I was lucky.

Bless your heart! (Literally)

Fortunately, I outgrew my asthma in 1970 and was completely off steroids till my

asthma came back with a vengeance in 1982. By 1990 they had me on 40 mg a day

of Pred again.

We do have a risk analysis to make here. In my own case the I have chosen that

the Prednisone is much more dangerous than the xolair.

At least I can breathe and have a more normal life.

Doug

Group founder

On Xolair since September 2003 and now PRED FREE!

[Guest guest]

If I am not mistaken, heart beat irregularities can also be a side effect of

some of the other asthma meds, and I know that the pred made me extremely

shaky--so much so that when my friend held my hand in a prayer circle, she asked

me if I had palsy.  Once I was off prednisone the shakiness subsided, but I

still have a little shakiness from time to time...but that could be old

age.....Ha:-)

 

I am not a medical person, but maybe before we " blame " xolair for all of the

problems it might do us all well to review the side effects of all of the

medicines was are taking besides the xolair and then look at our family medical

history.  I know I for one need to review the possible side effects of each of

the medicines I take.  I read them but it has been several years since I have

reviewed them....'  (Of course, xolair could be the culprit, but then again it

could be something else)

 

I do know that some of you keep up with that very carefully and I applaud

you....

I do have glaucoma after years of being on prednisone, but my mom had glaucoma,

too, and never once took a steroid even though she had asthma in her later life

as well as a heart problem (one side was weaker than the other which finally

caused her demise at 94!)

 

My dad had one heart attack, due more from stress than from stopped up

arteries.  His weren't.  My grandfather had two heart attacks, changed the way

he ate, took one heart pill and lived to be two weeks short of his 100th

birthday....so...my doctor knows my family history and periodically does a heart

test.  I have my blood tested on a very regular basis

 

From what I read the majority of all of us have regular checkups and with all of

the medicines and other issues, that is very wise....Hope all of you have

doctors who stay on top of your issues and want the very best care for

you......That kind of doctor is a true blessing!

 

Have a great day, all.....and stay out of the panic mode....someone said " wait

and see.... " I agree....Have a relaxing day doing what helps you relax. 

 

Adah--breathing freely....

 

 

From: Stesia <annastesia926@...>

Subject: Re: [ ] FDA - Xolair Safety Review

Date: Saturday, July 18, 2009, 12:57 AM

 

This is scary to me. I have serious side effects from prednisone. It

stunted my growth as a kid, I have very little hair on my body (which I do

say is nice in the summer because I rarely shave my legs), I have a

dowenger's hump on my back (since grade school) and issues with degenerative

disk disease in my spine. This winter was the first time I haven't had to

use prednisone since I can remember. Last winter was so bad that I was on

it from January to April. I guess I am lucky that I don't take it on a

daily basis, like I did as a child, but I am seriously over weight. Every

time I was on the stuff, I would gain 10 pounds or more. During the summer,

I may be able to take off 5 of it, if I was lucky.

Last year, I had an issue with my heart. I had an SVT attack where my heart

was beating 220bpm. I nearly died. We discovered that it was due to the

fact my Bi-pap (yes, I have sleep apnea too) was not set properly after

being serviced. I went through all the cardiac tests they could put me

through and other than a little leakage in my aorta, I am ok. But I suffer

with high blood pressure and worry about this news. I have been

experiencing palpatations or skipping. Now I wonder if it isn't the Xolair.

I finally find something that gets me away from the dependence on steriods

and now I have to worry about my heart - again. I would really like to know

how this medication would cause these things. Maybe a better explanation on

how it works in the body might help me to understand.

Kim

On Thu, Jul 16, 2009 at 3:30 PM, danielpercy <groups@ danielpercy.

com>wrote:

>

>

> Just had this pop up in my news feeds - as somebody receiving Xolair

> off-label for my urticaria, I really don't know what to do...

>

> ------------ --------- ------

>

> Early Communication about an Ongoing Safety Review of Omalizumab (marketed

> as Xolair)

>

> 7/16/2009

>

> FDA is evaluating interim safety findings from an ongoing study of Xolair

> (omalizumab) that suggests an increased number of cardiovascular and

> cerebrovascular adverse events in a group of patients using Xolair compared

> to a group of patients not given the drug (control group).

>

> Xolair is approved for use by adults and adolescents (12 years of age and

> above) with moderate to severe persistent asthma who test positive for

> reactivity to a perennial airborne allergen, and whose symptoms are

> inadequately controlled with inhaled corticosteroids.

>

> The ongoing study, titled Evaluating the Clinical Effectiveness and

> Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS), is an

> observational study of approximately 5000 Xolair treated patients and a

> control group of approximately 2500 non-Xolair treated patients. The primary

> objective of the EXCELS study is to assess the long-term safety profile of

> Xolair in patients followed for 5 years. Study patients are 12 years of age

> and older with moderate to severe persistent asthma and who have a positive

> skin test or blood test for an aeroallergen.

>

> The interim data, submitted by the manufacturer of Xolair (Genentech),

> suggests a disproportionate increase in ischemic heart disease, arrhythmias,

> cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular

> disorders, and embolic, thrombotic and thrombophlebitic events in patients

> treated with Xolair compared to the control group of patients not given the

> drug.

>

> FDA is not recommending any changes to the prescribing information for

> Xolair and is not advising patients to stop taking Xolair at this time.

> Until the evaluation of the EXCELS study is completed, healthcare providers

> and patients should be aware of the risks and benefits described in the

> prescribing information, as well as the new information from the ongoing

> EXCELS study that may suggest a risk of cardiovascular and cerebrovascular

> adverse events.

>

> This early communication is in keeping with FDA's commitment to inform the

> public about ongoing safety reviews of drugs. FDA has not made any

> conclusions regarding these data. The Agency is working with Genentech to

> obtain further information and will continue to review the strengths and

> limitations of these interim results. For example, since EXCELS is an

> observational study, there could be differences in underlying risk factors

> for cardiovascular and cerebrovascular events between the two study groups.

> The Agency will communicate any new findings when its analysis of the

> interim safety data is complete. The EXCELS study is ongoing and final

> results are not expected until 2012.

>

> The FDA urges both healthcare professionals and patients to report side

> effects from the use of omalizumab to the FDA's MedWatch Adverse Event

> Reporting program either online, by regular mail or by fax, using the

> contact information at the bottom of this page.

>

> This information reflects FDA's current analysis of available data

> concerning these drugs. Posting this information does not mean that FDA has

> concluded there is a causal relationship between the drug products and the

> emerging safety issue. Nor does it mean that FDA is advising health care

> professionals to discontinue prescribing these products. FDA is considering,

> but has not reached a conclusion about whether this information warrants any

> regulatory action. FDA intends to update this document when additional

> information or analyses become available.

>

>

>

--

From the abundance of the heart the mouth speaks. - Prince

[Guest guest]

Where can we get more information on what they're learning from this rather

new medication? I'm doing well, but I have as lot more fatigue than I used

to have and my PFT are declining, unhappily. I see my doctor next week, but

not the one who does Xolair shots.Carol

[Guest guest]

I sincerely apologize for all of the grammar errors in this post!  I won't go

back and fix them, but I will try to edit my posts a little more carefully. 

It's embarrassing for me, since I taught English for over 30 years and insisted

my students write correctly in their emails posts to me! 

From: Stesia <annastesia926@ gmail.com>

Subject: Re: [ ] FDA - Xolair Safety Review

Date: Saturday, July 18, 2009, 12:57 AM

 

This is scary to me. I have serious side effects from prednisone. It

stunted my growth as a kid, I have very little hair on my body (which I do

say is nice in the summer because I rarely shave my legs), I have a

dowenger's hump on my back (since grade school) and issues with degenerative

disk disease in my spine. This winter was the first time I haven't had to

use prednisone since I can remember. Last winter was so bad that I was on

it from January to April. I guess I am lucky that I don't take it on a

daily basis, like I did as a child, but I am seriously over weight. Every

time I was on the stuff, I would gain 10 pounds or more. During the summer,

I may be able to take off 5 of it, if I was lucky.

Last year, I had an issue with my heart. I had an SVT attack where my heart

was beating 220bpm. I nearly died. We discovered that it was due to the

fact my Bi-pap (yes, I have sleep apnea too) was not set properly after

being serviced. I went through all the cardiac tests they could put me

through and other than a little leakage in my aorta, I am ok. But I suffer

with high blood pressure and worry about this news. I have been

experiencing palpatations or skipping. Now I wonder if it isn't the Xolair.

I finally find something that gets me away from the dependence on steriods

and now I have to worry about my heart - again. I would really like to know

how this medication would cause these things. Maybe a better explanation on

how it works in the body might help me to understand.

Kim

On Thu, Jul 16, 2009 at 3:30 PM, danielpercy <groups@ danielpercy.

com>wrote:

>

>

> Just had this pop up in my news feeds - as somebody receiving Xolair

> off-label for my urticaria, I really don't know what to do...

>

> ------------ --------- ------

>

> Early Communication about an Ongoing Safety Review of Omalizumab (marketed

> as Xolair)

>

> 7/16/2009

>

> FDA is evaluating interim safety findings from an ongoing study of Xolair

> (omalizumab) that suggests an increased number of cardiovascular and

> cerebrovascular adverse events in a group of patients using Xolair compared

> to a group of patients not given the drug (control group).

>

> Xolair is approved for use by adults and adolescents (12 years of age and

> above) with moderate to severe persistent asthma who test positive for

> reactivity to a perennial airborne allergen, and whose symptoms are

> inadequately controlled with inhaled corticosteroids.

>

> The ongoing study, titled Evaluating the Clinical Effectiveness and

> Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS), is an

> observational study of approximately 5000 Xolair treated patients and a

> control group of approximately 2500 non-Xolair treated patients. The primary

> objective of the EXCELS study is to assess the long-term safety profile of

> Xolair in patients followed for 5 years. Study patients are 12 years of age

> and older with moderate to severe persistent asthma and who have a positive

> skin test or blood test for an aeroallergen.

>

> The interim data, submitted by the manufacturer of Xolair (Genentech),

> suggests a disproportionate increase in ischemic heart disease, arrhythmias,

> cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular

> disorders, and embolic, thrombotic and thrombophlebitic events in patients

> treated with Xolair compared to the control group of patients not given the

> drug.

>

> FDA is not recommending any changes to the prescribing information for

> Xolair and is not advising patients to stop taking Xolair at this time.

> Until the evaluation of the EXCELS study is completed, healthcare providers

> and patients should be aware of the risks and benefits described in the

> prescribing information, as well as the new information from the ongoing

> EXCELS study that may suggest a risk of cardiovascular and cerebrovascular

> adverse events.

>

> This early communication is in keeping with FDA's commitment to inform the

> public about ongoing safety reviews of drugs. FDA has not made any

> conclusions regarding these data. The Agency is working with Genentech to

> obtain further information and will continue to review the strengths and

> limitations of these interim results. For example, since EXCELS is an

> observational study, there could be differences in underlying risk factors

> for cardiovascular and cerebrovascular events between the two study groups.

> The Agency will communicate any new findings when its analysis of the

> interim safety data is complete. The EXCELS study is ongoing and final

> results are not expected until 2012.

>

> The FDA urges both healthcare professionals and patients to report side

> effects from the use of omalizumab to the FDA's MedWatch Adverse Event

> Reporting program either online, by regular mail or by fax, using the

> contact information at the bottom of this page.

>

> This information reflects FDA's current analysis of available data

> concerning these drugs. Posting this information does not mean that FDA has

> concluded there is a causal relationship between the drug products and the

> emerging safety issue. Nor does it mean that FDA is advising health care

> professionals to discontinue prescribing these products. FDA is considering,

> but has not reached a conclusion about whether this information warrants any

> regulatory action. FDA intends to update this document when additional

> information or analyses become available.

>

>

>

--

From the abundance of the heart the mouth speaks. - Prince

[Guest guest]

Hi adah,

How often do you get blood work done and is it for being on xolair?

thanks. jean

On Sat, Jul 18, 2009 at 1:07 PM, Adah Voigt <asthmatic50@...> wrote:

>

>

> If I am not mistaken, heart beat irregularities can also be a side effect

> of some of the other asthma meds, and I know that the pred made me extremely

> shaky--so much so that when my friend held my hand in a prayer circle, she

> asked me if I had palsy. Once I was off prednisone the shakiness subsided,

> but I still have a little shakiness from time to time...but that could be

> old age.....Ha:-)

>

> I am not a medical person, but maybe before we " blame " xolair for all of

> the problems it might do us all well to review the side effects of all of

> the medicines was are taking besides the xolair and then look at our family

> medical history. I know I for one need to review the possible side effects

> of each of the medicines I take. I read them but it has been several years

> since I have reviewed them....' (Of course, xolair could be the culprit,

> but then again it could be something else)

>

> I do know that some of you keep up with that very carefully and I applaud

> you....

> I do have glaucoma after years of being on prednisone, but my mom had

> glaucoma, too, and never once took a steroid even though she had asthma in

> her later life as well as a heart problem (one side was weaker than the

> other which finally caused her demise at 94!)

>

> My dad had one heart attack, due more from stress than from stopped up

> arteries. His weren't. My grandfather had two heart attacks, changed the

> way he ate, took one heart pill and lived to be two weeks short of his 100th

> birthday....so...my doctor knows my family history and periodically does a

> heart test. I have my blood tested on a very regular basis

>

> From what I read the majority of all of us have regular checkups and with

> all of the medicines and other issues, that is very wise....Hope all of you

> have doctors who stay on top of your issues and want the very best care for

> you......That kind of doctor is a true blessing!

>

> Have a great day, all.....and stay out of the panic mode....someone said

> " wait and see.... " I agree....Have a relaxing day doing what helps you

> relax.

>

> Adah--breathing freely....

>

>

>

>

> From: Stesia <annastesia926@... <annastesia926%40gmail.com>>

> Subject: Re: [ ] FDA - Xolair Safety Review

> < %40>

> Date: Saturday, July 18, 2009, 12:57 AM

>

>

>

> This is scary to me. I have serious side effects from prednisone. It

> stunted my growth as a kid, I have very little hair on my body (which I do

> say is nice in the summer because I rarely shave my legs), I have a

> dowenger's hump on my back (since grade school) and issues with

> degenerative

> disk disease in my spine. This winter was the first time I haven't had to

> use prednisone since I can remember. Last winter was so bad that I was on

> it from January to April. I guess I am lucky that I don't take it on a

> daily basis, like I did as a child, but I am seriously over weight. Every

> time I was on the stuff, I would gain 10 pounds or more. During the summer,

> I may be able to take off 5 of it, if I was lucky.

>

> Last year, I had an issue with my heart. I had an SVT attack where my heart

> was beating 220bpm. I nearly died. We discovered that it was due to the

> fact my Bi-pap (yes, I have sleep apnea too) was not set properly after

> being serviced. I went through all the cardiac tests they could put me

> through and other than a little leakage in my aorta, I am ok. But I suffer

> with high blood pressure and worry about this news. I have been

> experiencing palpatations or skipping. Now I wonder if it isn't the Xolair.

>

> I finally find something that gets me away from the dependence on steriods

> and now I have to worry about my heart - again. I would really like to know

> how this medication would cause these things. Maybe a better explanation on

> how it works in the body might help me to understand.

>

> Kim

>

> On Thu, Jul 16, 2009 at 3:30 PM, danielpercy <groups@ danielpercy.

> com>wrote:

>

> >

> >

> > Just had this pop up in my news feeds - as somebody receiving Xolair

> > off-label for my urticaria, I really don't know what to do...

> >

> > ------------ --------- ------

> >

> > Early Communication about an Ongoing Safety Review of Omalizumab

> (marketed

> > as Xolair)

> >

> > 7/16/2009

> >

> > FDA is evaluating interim safety findings from an ongoing study of Xolair

> > (omalizumab) that suggests an increased number of cardiovascular and

> > cerebrovascular adverse events in a group of patients using Xolair

> compared

> > to a group of patients not given the drug (control group).

> >

> > Xolair is approved for use by adults and adolescents (12 years of age and

> > above) with moderate to severe persistent asthma who test positive for

> > reactivity to a perennial airborne allergen, and whose symptoms are

> > inadequately controlled with inhaled corticosteroids.

> >

> > The ongoing study, titled Evaluating the Clinical Effectiveness and

> > Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS), is

> an

> > observational study of approximately 5000 Xolair treated patients and a

> > control group of approximately 2500 non-Xolair treated patients. The

> primary

> > objective of the EXCELS study is to assess the long-term safety profile

> of

> > Xolair in patients followed for 5 years. Study patients are 12 years of

> age

> > and older with moderate to severe persistent asthma and who have a

> positive

> > skin test or blood test for an aeroallergen.

> >

> > The interim data, submitted by the manufacturer of Xolair (Genentech),

> > suggests a disproportionate increase in ischemic heart disease,

> arrhythmias,

> > cardiomyopathy and cardiac failure, pulmonary hypertension,

> cerebrovascular

> > disorders, and embolic, thrombotic and thrombophlebitic events in

> patients

> > treated with Xolair compared to the control group of patients not given

> the

> > drug.

> >

> > FDA is not recommending any changes to the prescribing information for

> > Xolair and is not advising patients to stop taking Xolair at this time.

> > Until the evaluation of the EXCELS study is completed, healthcare

> providers

> > and patients should be aware of the risks and benefits described in the

> > prescribing information, as well as the new information from the ongoing

> > EXCELS study that may suggest a risk of cardiovascular and

> cerebrovascular

> > adverse events.

> >

> > This early communication is in keeping with FDA's commitment to inform

> the

> > public about ongoing safety reviews of drugs. FDA has not made any

> > conclusions regarding these data. The Agency is working with Genentech to

> > obtain further information and will continue to review the strengths and

> > limitations of these interim results. For example, since EXCELS is an

> > observational study, there could be differences in underlying risk

> factors

> > for cardiovascular and cerebrovascular events between the two study

> groups.

> > The Agency will communicate any new findings when its analysis of the

> > interim safety data is complete. The EXCELS study is ongoing and final

> > results are not expected until 2012.

> >

> > The FDA urges both healthcare professionals and patients to report side

> > effects from the use of omalizumab to the FDA's MedWatch Adverse Event

> > Reporting program either online, by regular mail or by fax, using the

> > contact information at the bottom of this page.

> >

> > This information reflects FDA's current analysis of available data

> > concerning these drugs. Posting this information does not mean that FDA

> has

> > concluded there is a causal relationship between the drug products and

> the

> > emerging safety issue. Nor does it mean that FDA is advising health care

> > professionals to discontinue prescribing these products. FDA is

> considering,

> > but has not reached a conclusion about whether this information warrants

> any

> > regulatory action. FDA intends to update this document when additional

> > information or analyses become available.

> >

> >

> >

>

> --

> From the abundance of the heart the mouth speaks. - Prince

>

>

[Guest guest]

You are so right Adah.  My pulmonologist discontnued my Theophyline as it can

cause angina (and other heart ailments?) in a small number of patients..  As I

have developed near daily angina dueto the cardio myopathy, she stopped it.  The

number/severity of pains decreased.  Sadly, they are not gone.  The good news is

that my asthma has not returned even without the supprt.

 Mike McBride

 

________________________________

From: Adah Voigt <asthmatic50@...>

Sent: Saturday, July 18, 2009 9:07:33 AM

Subject: Re: [ ] FDA - Xolair Safety Review

 

If I am not mistaken, heart beat irregularities can also be a side effect of

some of the other asthma meds, and I know that the pred made me extremely

shaky--so much so that when my friend held my hand in a prayer circle, she asked

me if I had palsy.  Once I was off prednisone the shakiness subsided, but I

still have a little shakiness from time to time...but that could be old

age.....Ha:- )

 

I am not a medical person, but maybe before we " blame " xolair for all of the

problems it might do us all well to review the side effects of all of the

medicines was are taking besides the xolair and then look at our family medical

history.  I know I for one need to review the possible side effects of each of

the medicines I take.  I read them but it has been several years since I have

reviewed them....'  (Of course, xolair could be the culprit, but then again it

could be something else)

 

I do know that some of you keep up with that very carefully and I applaud

you....

I do have glaucoma after years of being on prednisone, but my mom had glaucoma,

too, and never once took a steroid even though she had asthma in her later life

as well as a heart problem (one side was weaker than the other which finally

caused her demise at 94!)

 

My dad had one heart attack, due more from stress than from stopped up

arteries.  His weren't.  My grandfather had two heart attacks, changed the way

he ate, took one heart pill and lived to be two weeks short of his 100th

birthday.... so...my doctor knows my family history and periodically does a

heart test.  I have my blood tested on a very regular basis

 

From what I read the majority of all of us have regular checkups and with all of

the medicines and other issues, that is very wise....Hope all of you have

doctors who stay on top of your issues and want the very best care for

you......That kind of doctor is a true blessing!

 

Have a great day, all.....and stay out of the panic mode.....someone said " wait

and see.... " I agree....Have a relaxing day doing what helps you relax. 

 

Adah--breathing freely....

 

 

From: Stesia <annastesia926@ gmail.com>

Subject: Re: [ ] FDA - Xolair Safety Review

Date: Saturday, July 18, 2009, 12:57 AM

 

This is scary to me. I have serious side effects from prednisone. It

stunted my growth as a kid, I have very little hair on my body (which I do

say is nice in the summer because I rarely shave my legs), I have a

dowenger's hump on my back (since grade school) and issues with degenerative

disk disease in my spine. This winter was the first time I haven't had to

use prednisone since I can remember. Last winter was so bad that I was on

it from January to April. I guess I am lucky that I don't take it on a

daily basis, like I did as a child, but I am seriously over weight. Every

time I was on the stuff, I would gain 10 pounds or more. During the summer,

I may be able to take off 5 of it, if I was lucky.

Last year, I had an issue with my heart. I had an SVT attack where my heart

was beating 220bpm. I nearly died. We discovered that it was due to the

fact my Bi-pap (yes, I have sleep apnea too) was not set properly after

being serviced. I went through all the cardiac tests they could put me

through and other than a little leakage in my aorta, I am ok. But I suffer

with high blood pressure and worry about this news. I have been

experiencing palpatations or skipping. Now I wonder if it isn't the Xolair.

I finally find something that gets me away from the dependence on steriods

and now I have to worry about my heart - again. I would really like to know

how this medication would cause these things. Maybe a better explanation on

how it works in the body might help me to understand.

Kim

On Thu, Jul 16, 2009 at 3:30 PM, danielpercy <groups@ danielpercy.

com>wrote:

>

>

> Just had this pop up in my news feeds - as somebody receiving Xolair

> off-label for my urticaria, I really don't know what to do...

>

> ------------ --------- ------

>

> Early Communication about an Ongoing Safety Review of Omalizumab (marketed

> as Xolair)

>

> 7/16/2009

>

> FDA is evaluating interim safety findings from an ongoing study of Xolair

> (omalizumab) that suggests an increased number of cardiovascular and

> cerebrovascular adverse events in a group of patients using Xolair compared

> to a group of patients not given the drug (control group).

>

> Xolair is approved for use by adults and adolescents (12 years of age and

> above) with moderate to severe persistent asthma who test positive for

> reactivity to a perennial airborne allergen, and whose symptoms are

> inadequately controlled with inhaled corticosteroids.

>

> The ongoing study, titled Evaluating the Clinical Effectiveness and

> Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS), is an

> observational study of approximately 5000 Xolair treated patients and a

> control group of approximately 2500 non-Xolair treated patients. The primary

> objective of the EXCELS study is to assess the long-term safety profile of

> Xolair in patients followed for 5 years. Study patients are 12 years of age

> and older with moderate to severe persistent asthma and who have a positive

> skin test or blood test for an aeroallergen.

>

> The interim data, submitted by the manufacturer of Xolair (Genentech),

> suggests a disproportionate increase in ischemic heart disease, arrhythmias,

> cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular

> disorders, and embolic, thrombotic and thrombophlebitic events in patients

> treated with Xolair compared to the control group of patients not given the

> drug.

>

> FDA is not recommending any changes to the prescribing information for

> Xolair and is not advising patients to stop taking Xolair at this time.

> Until the evaluation of the EXCELS study is completed, healthcare providers

> and patients should be aware of the risks and benefits described in the

> prescribing information, as well as the new information from the ongoing

> EXCELS study that may suggest a risk of cardiovascular and cerebrovascular

> adverse events.

>

> This early communication is in keeping with FDA's commitment to inform the

> public about ongoing safety reviews of drugs. FDA has not made any

> conclusions regarding these data. The Agency is working with Genentech to

> obtain further information and will continue to review the strengths and

> limitations of these interim results. For example, since EXCELS is an

> observational study, there could be differences in underlying risk factors

> for cardiovascular and cerebrovascular events between the two study groups.

> The Agency will communicate any new findings when its analysis of the

> interim safety data is complete. The EXCELS study is ongoing and final

> results are not expected until 2012.

>

> The FDA urges both healthcare professionals and patients to report side

> effects from the use of omalizumab to the FDA's MedWatch Adverse Event

> Reporting program either online, by regular mail or by fax, using the

> contact information at the bottom of this page.

>

> This information reflects FDA's current analysis of available data

> concerning these drugs. Posting this information does not mean that FDA has

> concluded there is a causal relationship between the drug products and the

> emerging safety issue. Nor does it mean that FDA is advising health care

> professionals to discontinue prescribing these products. FDA is considering,

> but has not reached a conclusion about whether this information warrants any

> regulatory action. FDA intends to update this document when additional

> information or analyses become available.

>

>

>

--

From the abundance of the heart the mouth speaks. - Prince

[Guest guest]

I get blood work done every three to four months when I see my pcp.  He mainly

monitors me for anemia, but will include the entire blood tests (whatever they

are....) periodically.  I have not had any blood tests related to xolair since I

started on it.  My xolair doctor will asks if I am having checkups periodically,

just to make sure no other problems surface. 

 

 

 

>

> From: Stesia <annastesia926@ gmail.com <annastesia926% 40gmail.com> >

> Subject: Re: [ ] FDA - Xolair Safety Review

> < % 40groups. com>

> Date: Saturday, July 18, 2009, 12:57 AM

>

>

>

> This is scary to me. I have serious side effects from prednisone. It

> stunted my growth as a kid, I have very little hair on my body (which I do

> say is nice in the summer because I rarely shave my legs), I have a

> dowenger's hump on my back (since grade school) and issues with

> degenerative

> disk disease in my spine. This winter was the first time I haven't had to

> use prednisone since I can remember. Last winter was so bad that I was on

> it from January to April. I guess I am lucky that I don't take it on a

> daily basis, like I did as a child, but I am seriously over weight. Every

> time I was on the stuff, I would gain 10 pounds or more. During the summer,

> I may be able to take off 5 of it, if I was lucky.

>

> Last year, I had an issue with my heart. I had an SVT attack where my heart

> was beating 220bpm. I nearly died. We discovered that it was due to the

> fact my Bi-pap (yes, I have sleep apnea too) was not set properly after

> being serviced. I went through all the cardiac tests they could put me

> through and other than a little leakage in my aorta, I am ok. But I suffer

> with high blood pressure and worry about this news. I have been

> experiencing palpatations or skipping. Now I wonder if it isn't the Xolair.

>

> I finally find something that gets me away from the dependence on steriods

> and now I have to worry about my heart - again. I would really like to know

> how this medication would cause these things. Maybe a better explanation on

> how it works in the body might help me to understand.

>

> Kim

>

> On Thu, Jul 16, 2009 at 3:30 PM, danielpercy <groups@ danielpercy.

> com>wrote:

>

> >

> >

> > Just had this pop up in my news feeds - as somebody receiving Xolair

> > off-label for my urticaria, I really don't know what to do...

> >

> > ------------ --------- ------

> >

> > Early Communication about an Ongoing Safety Review of Omalizumab

> (marketed

> > as Xolair)

> >

> > 7/16/2009

> >

> > FDA is evaluating interim safety findings from an ongoing study of Xolair

> > (omalizumab) that suggests an increased number of cardiovascular and

> > cerebrovascular adverse events in a group of patients using Xolair

> compared

> > to a group of patients not given the drug (control group).

> >

> > Xolair is approved for use by adults and adolescents (12 years of age and

> > above) with moderate to severe persistent asthma who test positive for

> > reactivity to a perennial airborne allergen, and whose symptoms are

> > inadequately controlled with inhaled corticosteroids.

> >

> > The ongoing study, titled Evaluating the Clinical Effectiveness and

> > Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS), is

> an

> > observational study of approximately 5000 Xolair treated patients and a

> > control group of approximately 2500 non-Xolair treated patients. The

> primary

> > objective of the EXCELS study is to assess the long-term safety profile

> of

> > Xolair in patients followed for 5 years. Study patients are 12 years of

> age

> > and older with moderate to severe persistent asthma and who have a

> positive

> > skin test or blood test for an aeroallergen.

> >

> > The interim data, submitted by the manufacturer of Xolair (Genentech),

> > suggests a disproportionate increase in ischemic heart disease,

> arrhythmias,

> > cardiomyopathy and cardiac failure, pulmonary hypertension,

> cerebrovascular

> > disorders, and embolic, thrombotic and thrombophlebitic events in

> patients

> > treated with Xolair compared to the control group of patients not given

> the

> > drug.

> >

> > FDA is not recommending any changes to the prescribing information for

> > Xolair and is not advising patients to stop taking Xolair at this time.

> > Until the evaluation of the EXCELS study is completed, healthcare

> providers

> > and patients should be aware of the risks and benefits described in the

> > prescribing information, as well as the new information from the ongoing

> > EXCELS study that may suggest a risk of cardiovascular and

> cerebrovascular

> > adverse events.

> >

> > This early communication is in keeping with FDA's commitment to inform

> the

> > public about ongoing safety reviews of drugs. FDA has not made any

> > conclusions regarding these data. The Agency is working with Genentech to

> > obtain further information and will continue to review the strengths and

> > limitations of these interim results. For example, since EXCELS is an

> > observational study, there could be differences in underlying risk

> factors

> > for cardiovascular and cerebrovascular events between the two study

> groups.

> > The Agency will communicate any new findings when its analysis of the

> > interim safety data is complete. The EXCELS study is ongoing and final

> > results are not expected until 2012.

> >

> > The FDA urges both healthcare professionals and patients to report side

> > effects from the use of omalizumab to the FDA's MedWatch Adverse Event

> > Reporting program either online, by regular mail or by fax, using the

> > contact information at the bottom of this page.

> >

> > This information reflects FDA's current analysis of available data

> > concerning these drugs. Posting this information does not mean that FDA

> has

> > concluded there is a causal relationship between the drug products and

> the

> > emerging safety issue. Nor does it mean that FDA is advising health care

> > professionals to discontinue prescribing these products. FDA is

> considering,

> > but has not reached a conclusion about whether this information warrants

> any

> > regulatory action. FDA intends to update this document when additional

> > information or analyses become available.

> >

> >

> >

>

> --

> From the abundance of the heart the mouth speaks. - Prince

>

>

[Guest guest]

That's great to hear--that the asthma has not returned!

From: Stesia <annastesia926@ gmail.com>

Subject: Re: [ ] FDA - Xolair Safety Review

Date: Saturday, July 18, 2009, 12:57 AM

 

This is scary to me. I have serious side effects from prednisone. It

stunted my growth as a kid, I have very little hair on my body (which I do

say is nice in the summer because I rarely shave my legs), I have a

dowenger's hump on my back (since grade school) and issues with degenerative

disk disease in my spine. This winter was the first time I haven't had to

use prednisone since I can remember. Last winter was so bad that I was on

it from January to April. I guess I am lucky that I don't take it on a

daily basis, like I did as a child, but I am seriously over weight. Every

time I was on the stuff, I would gain 10 pounds or more. During the summer,

I may be able to take off 5 of it, if I was lucky.

Last year, I had an issue with my heart. I had an SVT attack where my heart

was beating 220bpm. I nearly died. We discovered that it was due to the

fact my Bi-pap (yes, I have sleep apnea too) was not set properly after

being serviced. I went through all the cardiac tests they could put me

through and other than a little leakage in my aorta, I am ok. But I suffer

with high blood pressure and worry about this news. I have been

experiencing palpatations or skipping. Now I wonder if it isn't the Xolair.

I finally find something that gets me away from the dependence on steriods

and now I have to worry about my heart - again. I would really like to know

how this medication would cause these things. Maybe a better explanation on

how it works in the body might help me to understand.

Kim

On Thu, Jul 16, 2009 at 3:30 PM, danielpercy <groups@ danielpercy.

com>wrote:

>

>

> Just had this pop up in my news feeds - as somebody receiving Xolair

> off-label for my urticaria, I really don't know what to do...

>

> ------------ --------- ------

>

> Early Communication about an Ongoing Safety Review of Omalizumab (marketed

> as Xolair)

>

> 7/16/2009

>

> FDA is evaluating interim safety findings from an ongoing study of Xolair

> (omalizumab) that suggests an increased number of cardiovascular and

> cerebrovascular adverse events in a group of patients using Xolair compared

> to a group of patients not given the drug (control group).

>

> Xolair is approved for use by adults and adolescents (12 years of age and

> above) with moderate to severe persistent asthma who test positive for

> reactivity to a perennial airborne allergen, and whose symptoms are

> inadequately controlled with inhaled corticosteroids.

>

> The ongoing study, titled Evaluating the Clinical Effectiveness and

> Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS), is an

> observational study of approximately 5000 Xolair treated patients and a

> control group of approximately 2500 non-Xolair treated patients. The primary

> objective of the EXCELS study is to assess the long-term safety profile of

> Xolair in patients followed for 5 years. Study patients are 12 years of age

> and older with moderate to severe persistent asthma and who have a positive

> skin test or blood test for an aeroallergen.

>

> The interim data, submitted by the manufacturer of Xolair (Genentech),

> suggests a disproportionate increase in ischemic heart disease, arrhythmias,

> cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular

> disorders, and embolic, thrombotic and thrombophlebitic events in patients

> treated with Xolair compared to the control group of patients not given the

> drug.

>

> FDA is not recommending any changes to the prescribing information for

> Xolair and is not advising patients to stop taking Xolair at this time.

> Until the evaluation of the EXCELS study is completed, healthcare providers

> and patients should be aware of the risks and benefits described in the

> prescribing information, as well as the new information from the ongoing

> EXCELS study that may suggest a risk of cardiovascular and cerebrovascular

> adverse events.

>

> This early communication is in keeping with FDA's commitment to inform the

> public about ongoing safety reviews of drugs. FDA has not made any

> conclusions regarding these data. The Agency is working with Genentech to

> obtain further information and will continue to review the strengths and

> limitations of these interim results. For example, since EXCELS is an

> observational study, there could be differences in underlying risk factors

> for cardiovascular and cerebrovascular events between the two study groups.

> The Agency will communicate any new findings when its analysis of the

> interim safety data is complete. The EXCELS study is ongoing and final

> results are not expected until 2012.

>

> The FDA urges both healthcare professionals and patients to report side

> effects from the use of omalizumab to the FDA's MedWatch Adverse Event

> Reporting program either online, by regular mail or by fax, using the

> contact information at the bottom of this page.

>

> This information reflects FDA's current analysis of available data

> concerning these drugs. Posting this information does not mean that FDA has

> concluded there is a causal relationship between the drug products and the

> emerging safety issue. Nor does it mean that FDA is advising health care

> professionals to discontinue prescribing these products. FDA is considering,

> but has not reached a conclusion about whether this information warrants any

> regulatory action. FDA intends to update this document when additional

> information or analyses become available.

>

>

>

--

From the abundance of the heart the mouth speaks. - Prince

[Guest guest]

This study is huge! The cerebral problems are very real. I spoke to Genetech

this past spring, as my daughter suffered a severe frontal lobe problem that

began just 12 hours after her 14th set of injections in Dec 2008. We went to

several specialists for severe dizziness, nausea, memory loss, headache,

hallucinations, etc ... The world-renowned specialist we finally found who

treated her to a significant point of healing said from the beginning that this

was a medically-induced attack on the frontal lobe. We had significant problems

getting the make-up of the compound from my daughter's immunologist, and I even

heard him tell this specialist that I was crazy for making a connection! This

particular specialist who helped my daughter is very well quoted as saying, " any

medication can cause any reaction in any person and any organ at any time! "

We stopped xolair and daughter is much better!

<><

> >

> > Just had this pop up in my news feeds - as somebody receiving Xolair

off-label for my urticaria, I really don't know what to do...

> >

> > ---------------------------

> >

> > Early Communication about an Ongoing Safety Review of Omalizumab (marketed

as Xolair)

> >

> > 7/16/2009

> >

> > FDA is evaluating interim safety findings from an ongoing study of Xolair

(omalizumab) that suggests an increased number of cardiovascular and

cerebrovascular adverse events in a group of patients using Xolair compared to a

group of patients not given the drug (control group).

> >

> > Xolair is approved for use by adults and adolescents (12 years of age and

above) with moderate to severe persistent asthma who test positive for

reactivity to a perennial airborne allergen, and whose symptoms are inadequately

controlled with inhaled corticosteroids.

> >

> > The ongoing study, titled Evaluating the Clinical Effectiveness and

Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS), is an

observational study of approximately 5000 Xolair treated patients and a control

group of approximately 2500 non-Xolair treated patients. The primary objective

of the EXCELS study is to assess the long-term safety profile of Xolair in

patients followed for 5 years. Study patients are 12 years of age and older with

moderate to severe persistent asthma and who have a positive skin test or blood

test for an aeroallergen.

> >

> > The interim data, submitted by the manufacturer of Xolair (Genentech),

suggests a disproportionate increase in ischemic heart disease, arrhythmias,

cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular

disorders, and embolic, thrombotic and thrombophlebitic events in patients

treated with Xolair compared to the control group of patients not given the

drug.

> >

> > FDA is not recommending any changes to the prescribing information for

Xolair and is not advising patients to stop taking Xolair at this time. Until

the evaluation of the EXCELS study is completed, healthcare providers and

patients should be aware of the risks and benefits described in the prescribing

information, as well as the new information from the ongoing EXCELS study that

may suggest a risk of cardiovascular and cerebrovascular adverse events.

> >

> > This early communication is in keeping with FDA's commitment to inform the

public about ongoing safety reviews of drugs. FDA has not made any conclusions

regarding these data. The Agency is working with Genentech to obtain further

information and will continue to review the strengths and limitations of these

interim results. For example, since EXCELS is an observational study, there

could be differences in underlying risk factors for cardiovascular and

cerebrovascular events between the two study groups. The Agency will communicate

any new findings when its analysis of the interim safety data is complete. The

EXCELS study is ongoing and final results are not expected until 2012.

> >

> > The FDA urges both healthcare professionals and patients to report side

effects from the use of omalizumab to the FDA's MedWatch Adverse Event Reporting

program either online, by regular mail or by fax, using the contact information

at the bottom of this page.

> >

> > This information reflects FDA's current analysis of available data

concerning these drugs. Posting this information does not mean that FDA has

concluded there is a causal relationship between the drug products and the

emerging safety issue. Nor does it mean that FDA is advising health care

professionals to discontinue prescribing these products. FDA is considering, but

has not reached a conclusion about whether this information warrants any

regulatory action. FDA intends to update this document when additional

information or analyses become available.

> >

>

[Guest guest]

thank you. Jean

On Sat, Jul 18, 2009 at 8:47 PM, Adah Voigt <asthmatic50@...> wrote:

>

>

> I get blood work done every three to four months when I see my pcp. He

> mainly monitors me for anemia, but will include the entire blood tests

> (whatever they are....) periodically. I have not had any blood tests

> related to xolair since I started on it. My xolair doctor will asks if I am

> having checkups periodically, just to make sure no other problems surface.

>

>

>

>

> >

> > From: Stesia <annastesia926@ gmail.com <annastesia926% 40gmail.com>

> >

> > Subject: Re: [ ] FDA - Xolair Safety Review

> > < % 40groups. com>

> > Date: Saturday, July 18, 2009, 12:57 AM

> >

> >

> >

> > This is scary to me. I have serious side effects from prednisone. It

> > stunted my growth as a kid, I have very little hair on my body (which I

> do

> > say is nice in the summer because I rarely shave my legs), I have a

> > dowenger's hump on my back (since grade school) and issues with

> > degenerative

> > disk disease in my spine. This winter was the first time I haven't had to

> > use prednisone since I can remember. Last winter was so bad that I was on

> > it from January to April. I guess I am lucky that I don't take it on a

> > daily basis, like I did as a child, but I am seriously over weight. Every

> > time I was on the stuff, I would gain 10 pounds or more. During the

> summer,

> > I may be able to take off 5 of it, if I was lucky.

> >

> > Last year, I had an issue with my heart. I had an SVT attack where my

> heart

> > was beating 220bpm. I nearly died. We discovered that it was due to the

> > fact my Bi-pap (yes, I have sleep apnea too) was not set properly after

> > being serviced. I went through all the cardiac tests they could put me

> > through and other than a little leakage in my aorta, I am ok. But I

> suffer

> > with high blood pressure and worry about this news. I have been

> > experiencing palpatations or skipping. Now I wonder if it isn't the

> Xolair.

> >

> > I finally find something that gets me away from the dependence on

> steriods

> > and now I have to worry about my heart - again. I would really like to

> know

> > how this medication would cause these things. Maybe a better explanation

> on

> > how it works in the body might help me to understand.

> >

> > Kim

> >

> > On Thu, Jul 16, 2009 at 3:30 PM, danielpercy <groups@ danielpercy.

> > com>wrote:

> >

> > >

> > >

> > > Just had this pop up in my news feeds - as somebody receiving Xolair

> > > off-label for my urticaria, I really don't know what to do...

> > >

> > > ------------ --------- ------

> > >

> > > Early Communication about an Ongoing Safety Review of Omalizumab

> > (marketed

> > > as Xolair)

> > >

> > > 7/16/2009

> > >

> > > FDA is evaluating interim safety findings from an ongoing study of

> Xolair

> > > (omalizumab) that suggests an increased number of cardiovascular and

> > > cerebrovascular adverse events in a group of patients using Xolair

> > compared

> > > to a group of patients not given the drug (control group).

> > >

> > > Xolair is approved for use by adults and adolescents (12 years of age

> and

> > > above) with moderate to severe persistent asthma who test positive for

> > > reactivity to a perennial airborne allergen, and whose symptoms are

> > > inadequately controlled with inhaled corticosteroids.

> > >

> > > The ongoing study, titled Evaluating the Clinical Effectiveness and

> > > Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS),

> is

> > an

> > > observational study of approximately 5000 Xolair treated patients and a

> > > control group of approximately 2500 non-Xolair treated patients. The

> > primary

> > > objective of the EXCELS study is to assess the long-term safety profile

> > of

> > > Xolair in patients followed for 5 years. Study patients are 12 years of

> > age

> > > and older with moderate to severe persistent asthma and who have a

> > positive

> > > skin test or blood test for an aeroallergen.

> > >

> > > The interim data, submitted by the manufacturer of Xolair (Genentech),

> > > suggests a disproportionate increase in ischemic heart disease,

> > arrhythmias,

> > > cardiomyopathy and cardiac failure, pulmonary hypertension,

> > cerebrovascular

> > > disorders, and embolic, thrombotic and thrombophlebitic events in

> > patients

> > > treated with Xolair compared to the control group of patients not given

> > the

> > > drug.

> > >

> > > FDA is not recommending any changes to the prescribing information for

> > > Xolair and is not advising patients to stop taking Xolair at this time.

> > > Until the evaluation of the EXCELS study is completed, healthcare

> > providers

> > > and patients should be aware of the risks and benefits described in the

> > > prescribing information, as well as the new information from the

> ongoing

> > > EXCELS study that may suggest a risk of cardiovascular and

> > cerebrovascular

> > > adverse events.

> > >

> > > This early communication is in keeping with FDA's commitment to inform

> > the

> > > public about ongoing safety reviews of drugs. FDA has not made any

> > > conclusions regarding these data. The Agency is working with Genentech

> to

> > > obtain further information and will continue to review the strengths

> and

> > > limitations of these interim results. For example, since EXCELS is an

> > > observational study, there could be differences in underlying risk

> > factors

> > > for cardiovascular and cerebrovascular events between the two study

> > groups.

> > > The Agency will communicate any new findings when its analysis of the

> > > interim safety data is complete. The EXCELS study is ongoing and final

> > > results are not expected until 2012.

> > >

> > > The FDA urges both healthcare professionals and patients to report side

> > > effects from the use of omalizumab to the FDA's MedWatch Adverse Event

> > > Reporting program either online, by regular mail or by fax, using the

> > > contact information at the bottom of this page.

> > >

> > > This information reflects FDA's current analysis of available data

> > > concerning these drugs. Posting this information does not mean that FDA

> > has

> > > concluded there is a causal relationship between the drug products and

> > the

> > > emerging safety issue. Nor does it mean that FDA is advising health

> care

> > > professionals to discontinue prescribing these products. FDA is

> > considering,

> > > but has not reached a conclusion about whether this information

> warrants

> > any

> > > regulatory action. FDA intends to update this document when additional

> > > information or analyses become available.

> > >

> > >

> > >

> >

> > --

> > From the abundance of the heart the mouth speaks. - Prince

> >

> >

[Guest guest]

Actually, the study as currently reported addresses cardiac events, not cerebral

or neurological events. I cannot find that they have released any information

regarding reported neurological events as yet. It is a large study - 5,000

Xolair clients and a control group of about 2500, if the press report I read was

correct.

I hope that your daughter's specialist reported his suspicion that Xolair caused

her neurological symptoms. He is absolutely right that any medicine can cause

any kind of reaction, although generally the course of reactions are predictable

and related to the mechanism of action of a drug and how the body processes.

I'm glad your daughter is doing much better.

Addy

Group co-owner

- In , " romanianchic2 " <slgolderl@...> wrote:

>

> This study is huge! The cerebral problems are very real. I spoke to Genetech

this past spring, as my daughter suffered a severe frontal lobe problem that

began just 12 hours after her 14th set of injections in Dec 2008. We went to

several specialists for severe dizziness, nausea, memory loss, headache,

hallucinations, etc ... The world-renowned specialist we finally found who

treated her to a significant point of healing said from the beginning that this

was a medically-induced attack on the frontal lobe. We had significant problems

getting the make-up of the compound from my daughter's immunologist, and I even

heard him tell this specialist that I was crazy for making a connection! This

particular specialist who helped my daughter is very well quoted as saying, " any

medication can cause any reaction in any person and any organ at any time! "

> We stopped xolair and daughter is much better!

> <><

>

> > >

> > > Just had this pop up in my news feeds - as somebody receiving Xolair

off-label for my urticaria, I really don't know what to do...

> > >

> > > ---------------------------

> > >

> > > Early Communication about an Ongoing Safety Review of Omalizumab (marketed

as Xolair)

> > >

> > > 7/16/2009

> > >

> > > FDA is evaluating interim safety findings from an ongoing study of Xolair

(omalizumab) that suggests an increased number of cardiovascular and

cerebrovascular adverse events in a group of patients using Xolair compared to a

group of patients not given the drug (control group).

> > >

> > > Xolair is approved for use by adults and adolescents (12 years of age and

above) with moderate to severe persistent asthma who test positive for

reactivity to a perennial airborne allergen, and whose symptoms are inadequately

controlled with inhaled corticosteroids.

> > >

> > > The ongoing study, titled Evaluating the Clinical Effectiveness and

Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS), is an

observational study of approximately 5000 Xolair treated patients and a control

group of approximately 2500 non-Xolair treated patients. The primary objective

of the EXCELS study is to assess the long-term safety profile of Xolair in

patients followed for 5 years. Study patients are 12 years of age and older with

moderate to severe persistent asthma and who have a positive skin test or blood

test for an aeroallergen.

> > >

> > > The interim data, submitted by the manufacturer of Xolair (Genentech),

suggests a disproportionate increase in ischemic heart disease, arrhythmias,

cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular

disorders, and embolic, thrombotic and thrombophlebitic events in patients

treated with Xolair compared to the control group of patients not given the

drug.

> > >

> > > FDA is not recommending any changes to the prescribing information for

Xolair and is not advising patients to stop taking Xolair at this time. Until

the evaluation of the EXCELS study is completed, healthcare providers and

patients should be aware of the risks and benefits described in the prescribing

information, as well as the new information from the ongoing EXCELS study that

may suggest a risk of cardiovascular and cerebrovascular adverse events.

> > >

> > > This early communication is in keeping with FDA's commitment to inform the

public about ongoing safety reviews of drugs. FDA has not made any conclusions

regarding these data. The Agency is working with Genentech to obtain further

information and will continue to review the strengths and limitations of these

interim results. For example, since EXCELS is an observational study, there

could be differences in underlying risk factors for cardiovascular and

cerebrovascular events between the two study groups. The Agency will communicate

any new findings when its analysis of the interim safety data is complete. The

EXCELS study is ongoing and final results are not expected until 2012.

> > >

> > > The FDA urges both healthcare professionals and patients to report side

effects from the use of omalizumab to the FDA's MedWatch Adverse Event Reporting

program either online, by regular mail or by fax, using the contact information

at the bottom of this page.

> > >

> > > This information reflects FDA's current analysis of available data

concerning these drugs. Posting this information does not mean that FDA has

concluded there is a causal relationship between the drug products and the

emerging safety issue. Nor does it mean that FDA is advising health care

professionals to discontinue prescribing these products. FDA is considering, but

has not reached a conclusion about whether this information warrants any

regulatory action. FDA intends to update this document when additional

information or analyses become available.

> > >

> >

>

[Guest guest]

Leigh, my IgE scores have varied by as much as several hundred points on any

reading BEFORE I start Xolair. I've had MANY IgE readings since I started seeing

allergists MANY years ago and they've all varied.

I have not read any literature that confirms the efficacy of Xolair as related

to food allergies. Food allergies are a strange animal, and even though they fit

in the Type I hypersensitivity profile, they do not behave with close similarity

to other Type I hypersensitivities.

It does sound like you need to have a good long chat with your doctor. My life

was so miserable before Xolair, and is so much improved, I cannot imagine having

to do without it.

My pulmo told me that ideally folks will be on Xolair 3-5 years and then be able

to go off it, provided they're bodies do not continue to make new IgE. I wonder

if that is the reason that National Jewish has terminated some of their Xolair

patients. Unfortunately, my body apparently happily continues to make new IgE,

and lots of it.

Good luck,

Addy

Group Co-owner

> > >

> > >

> > > My mom just sent this to me. SHe doesn't know htat I've just been to a

cardiologist trying to figure out the source of a mysterious arrhythmia.

Fortunately, the arrhythmia isn't hindering my heart right now nor is there any

sign of other heart disease, but I hope it isn't Xolair.

> > >

> > > Oh crap.

> > >

> > > --Kitty

> > >

> > > --- In , " danielpercy " <groups@ >

wrote:

> > > >

> > > > Just had this pop up in my news feeds - as somebody receiving Xolair

off-label for my urticaria, I really don't know what to do...

> > > >

> > > > ------------ --------- ------

> > > >

> > > > Early Communication about an Ongoing Safety Review of Omalizumab

(marketed as Xolair)

> > > >

> > > > 7/16/2009

> > > >

> > > > FDA is evaluating interim safety findings from an ongoing study of

Xolair (omalizumab) that suggests an increased number of cardiovascular and

cerebrovascular adverse events in a group of patients using Xolair compared to a

group of patients not given the drug (control group).

> > > >

> > > > Xolair is approved for use by adults and adolescents (12 years of age

and above) with moderate to severe persistent asthma who test positive for

reactivity to a perennial airborne allergen, and whose symptoms are inadequately

controlled with inhaled corticosteroids.

> > > >

> > > > The ongoing study, titled Evaluating the Clinical Effectiveness and

Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS), is an

observational study of approximately 5000 Xolair treated patients and a control

group of approximately 2500 non-Xolair treated patients. The primary objective

of the EXCELS study is to assess the long-term safety profile of Xolair in

patients followed for 5 years. Study patients are 12 years of age and older with

moderate to severe persistent asthma and who have a positive skin test or blood

test for an aeroallergen.

> > > >

> > > > The interim data, submitted by the manufacturer of Xolair (Genentech),

suggests a disproportionate increase in ischemic heart disease, arrhythmias,

cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular

disorders, and embolic, thrombotic and thrombophlebitic events in patients

treated with Xolair compared to the control group of patients not given the

drug.

> > > >

> > > > FDA is not recommending any changes to the prescribing information for

Xolair and is not advising patients to stop taking Xolair at this time. Until

the evaluation of the EXCELS study is completed, healthcare providers and

patients should be aware of the risks and benefits described in the prescribing

information, as well as the new information from the ongoing EXCELS study that

may suggest a risk of cardiovascular and cerebrovascular adverse events.

> > > >

> > > > This early communication is in keeping with FDA's commitment to inform

the public about ongoing safety reviews of drugs. FDA has not made any

conclusions regarding these data. The Agency is working with Genentech to obtain

further information and will continue to review the strengths and limitations of

these interim results. For example, since EXCELS is an observational study,

there could be differences in underlying risk factors for cardiovascular and

cerebrovascular events between the two study groups. The Agency will communicate

any new findings when its analysis of the interim safety data is complete. The

EXCELS study is ongoing and final results are not expected until 2012.

> > > >

> > > > The FDA urges both healthcare professionals and patients to report side

effects from the use of omalizumab to the FDA's MedWatch Adverse Event Reporting

program either online, by regular mail or by fax, using the contact information

at the bottom of this page.

> > > >

> > > > This information reflects FDA's current analysis of available data

concerning these drugs. Posting this information does not mean that FDA has

concluded there is a causal relationship between the drug products and the

emerging safety issue. Nor does it mean that FDA is advising health care

professionals to discontinue prescribing these products. FDA is considering, but

has not reached a conclusion about whether this information warrants any

regulatory action. FDA intends to update this document when additional

information or analyses become available.

> > > >

> > >

> >

>

>

[Guest guest]

>

> Hi Leigh,

>

> If you are concerned about how you are reacting to the medication, why don't

you stop taking it? It is not like prednisone, you can just stop taking it. We

are all allowed to chose what we put into our bodies, food, medication and

otherwise.

>

>

>

>

I agree with . There are some on this board who are having nothing but

problems with Xolair and need to speak with their doctors about quitting the

medication and going back on Prednisone.

Doug

Group founder

[Guest guest]

This really scares me as I've been on xolair for 9 months and recently have had

memory loss that comes and goes, where I cannot remember people I know and

sometimes cannot remember blocks of time. Also dizziness and nausea and blurred

vision. My brain MRI was " normal " but I'm scheduled to see a neurosurgeon as

I've had brain surgery in the past and they suspect it could be that condition

returning again. Now I'm worried its xolair.

> >

> > Hi Leigh,

> >

> > If you are concerned about how you are reacting to the medication, why don't

you stop taking it? It is not like prednisone, you can just stop taking it. We

are all allowed to chose what we put into our bodies, food, medication and

otherwise.

> >

> >

> >

> >

>

>

> I agree with . There are some on this board who are having nothing but

problems with Xolair and need to speak with their doctors about quitting the

medication and going back on Prednisone.

>

> Doug

> Group founder

>

[Guest guest]

<< For me the benefits of this therapy far out way the risks.>>

Me too! I really DON'T want to go back to Presnisone!

[Guest guest]

I don't think most people should go back to their doctors and ask to be put on

prednisone. Go back to their docs when they're having trouble with Xolair, yes.

There are alternatives to prednisone for many people. It's not always that cut

and dried. The docs often don't have the whole story about Xolair because it

isn't being put out there and different docs have different reasons for putting

patients on Xolair.

> >

> > Hi Leigh,

> >

> > If you are concerned about how you are reacting to the medication, why don't

you stop taking it? It is not like prednisone, you can just stop taking it. We

are all allowed to chose what we put into our bodies, food, medication and

otherwise.

> >

> >

> >

> >

>

>

> I agree with . There are some on this board who are having nothing but

problems with Xolair and need to speak with their doctors about quitting the

medication and going back on Prednisone.

>

> Doug

> Group founder

>