Re: Re: FDA - Xolair Safety Review

[Guest guest]

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]

This is lovely....I was just diagnosed in April with hypertrophic

Cardiomyopathy.

 Mike McBride

  " Blessed is he who, with a hunger that is never satisfied, day and night

throughout this present life makes prayer and the psalms his food and drink, and

strengthens himself by reading of God's glory in Scripture. Such communion will

lead the soul to ever-increasing joy in the age to come. " St. of Karpathos.

________________________________

From: lurkitty117 <scruffy@...>

Sent: Thursday, July 16, 2009 9:02:53 PM

Subject: [ ] Re: FDA - Xolair Safety Review

 

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]

I was on blood pressure meds long before I began taking Xolair and actually I am

up to 3 meds for it now. I do have a lot of cranial hypertension now and it is

often associated with Sampter's. I am still doing my shots at home. When I tried

to get off the shots, I became quite ill.

Gwendolyn Rafter,MAOM,MBA/HRM

From: instdesgn1 <instdesgn1@...>

Subject: [ ] Re: FDA - Xolair Safety Review

Date: Friday, July 17, 2009, 3:14 PM

 

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]

At NJ, they have discovered a Patent Foreman Ovale and I am to return for a

stress/echo with bubble to deternmine

if I need to have the PFO closed.  They have discovered a relationship between

the PFO and SOB.  So indeedy there is

an association between the heart and lungs and the attending symptoms.

Have you had a cardiac workup? Are you receiving an albuterol treatment during

those PFTs?  If so, there is an association between albuterol and the symptoms

withwhich you present. 

 Did the symptoms go away after you stopped xolair?

One thing I did read once which possibly explains a xolair/heart connecton is

that xolair has an effect on Nitrous Oxide levels.  I will look for this article

and post it after I find it.

Leigh

 

________________________________

From: instdesgn1 <instdesgn1@...>

Sent: Friday, July 17, 2009 2:14:04 PM

Subject: [ ] Re: FDA - Xolair Safety Review

 

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]

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

________________________________

From: uca79iii <uca79iii@...>

Sent: Friday, July 17, 2009 5:01:31 PM

Subject: [ ] Re: FDA - Xolair Safety Review

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]

Dear Doug:  Thanks for this post.  All the years I was on prednisone, my

allergist would tell me to do this and do that to try and lessen some of the

side effects.  For example, I began taking extra calcium tablets way back then. 

However, I, too, weighed the side effects versus not breathing!  the Prednisone

always won out:-)

 

I have done the same with xolair.  I typed in xolair research and found a site

that listed articles on xolair and research studies on the various aspects of

xolair and on some of the concerns and questions that have been posed by members

of this group.  I read through a couple of them, but did not have time to scan

anymore.  That might be something we all could look at from time to time.  I

know there are some in this group who keep up with the latest research and the

latest articles. 

 

My dose has been reduced so I was interested in an article that dealt with the

effects of reducing the dosage of xolair and the debate about whether or not

there would be a time limit for people being on xolair.  Can't tell you the

bottom line because I did not read all of the article.  I will go back and read

it.  So far I have done pretty well... what the doctor did was keep me on 150 mg

but every 6 weeks instead of 4 weeks.  I have had a sinus infection and had to

have an antibiotic, but NO prednisone!  And I think the sinus infection

developed because I was under tremendous stress with the death of my mom--back

in January.  I don't think I am part of any test group, even though my xolair

doctor has several xolair research groups in his clinic.  For one study, I

qualified until they asked me my age and said " Oops...sorry....the cutoff age is

65.. "   I am 71! 

 

I know this is long, but I, too, think each person must weigh all of the issues

involved.  For me, being able to breath and pretty much do what I want and need

to do, is pretty important.  I have lived the greater portion of my life, but I

would like the quality of life for whatever years God leaves me here.......

 

Adah.

From: uca79iii <uca79iii@...>

Subject: [ ] Re: FDA - Xolair Safety Review

Date: Friday, July 17, 2009, 5:01 PM

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]

Addy,

How do they know you have bone loss due to Xolair? I've never heard of that

before.

Glad you are doing well on it. I'm SO envious of you all.

Nan

Sent from my Verizon Wireless BlackBerry

[Guest guest]

I know you are asking Doug, but for five years I was on Prednisone nearly all

the time..  At times I could get down to 5mg every other day and then my asthma

would escalate and I would go back on the 40 for two days, 20 for four, 10 for

two or three and then try the 5.  There were very few weeks in the five years

when I was not on prednisone.  Finally the doctor started me on an inhaler

regimen---four inhalers, the last one a cortisone (don't ask me, it was too long

ago now) and from time to time would change to another one or drop one totally. 

I did not take any pills except for hydroxyzine at night and occasionally

allegra.  When Advair came out, he started me on that and now I am on Spiriva

and Advair and Singulair...Albuterol only when necessary, which is seldom.  I

use Advair once a day.  But even with the Advair and the others, prednisone was

necessary two to three times a year until I started xolair.  I had terrible

sinus infections which

exacerbated the asthma, so it would be antibiotics and prednisone.  My

allergist was afraid I would develop a resistance to the antibiotics, but so far

whatever he decides to give me works.   That's my story....no prednisone at all

in the last three years.

From: Leigh McCall-Alton <mccallalton@...>

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

Date: Friday, July 17, 2009, 5:09 PM

 

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

____________ _________ _________ __

From: uca79iii <uca79iiigmail (DOT) com>

Sent: Friday, July 17, 2009 5:01:31 PM

Subject: [ ] Re: FDA - Xolair Safety Review

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]

Amen and me, too--questions about the study.

From: pyle456 <jamcculloch2@...>

Subject: [ ] Re: FDA - Xolair Safety Review

Date: Friday, July 17, 2009, 7:21 PM

 

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

>

> --- In , Leigh McCall-Alton <mccallalton@ >

wrote:

> >

> > 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]

Hi,

I'm just curious what you mean by a medically-induced attack on the frontal

lobe. I am a neurosurgery nurse and to be honest I have never heard of such a

thing. Did she have a bleed in her brain or a small attack of ischemia when the

brain is deprived of oxygen or a seizure? All of these things could easily

explain those symptoms.

I am glad she is doing better.

________________________________

From: romanianchic2 <slgolderl@...>

Sent: Saturday, July 18, 2009 9:26:07 PM

Subject: [ ] Re: FDA - Xolair Safety Review

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.

> >

>

__________________________________________________________________

Make your browsing faster, safer, and easier with the new Internet Explorer® 8.

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[Guest guest]

Now I know why the pulmonologist at the Mayo clinic refused to help me take my

Xolair injection when it was due while I was there.

The Mayo Clinic participated in the original studies for Xolair and does not as

a rule prescribe it.  They do not care for it at the Mayo Clinic.  I trust those

doctors more than I do some wahoo pulmonologists who do not keep current.

In fact, the Mayo pulmonologist acted sort of agitated when I merely asked to

have the nurse administer it to me.

And also, a doctor at National Jewish told me that half of the patients who were

originally on Xolair at their facility are no longer on it.

Keep in mind, that National Jewish is Number 1 in pulmonology and the Mayo

Clinic is number 2.

The very first time I took Xolair, my blood pressure went up and the doctor told

my husband that it was the prednisone which I was on.

After it was in me for an hour, I could smell dust on blinds from 15 feet away. 

When we went to lunch that day, I could smell odors coming

from the carpeting of the restaurant and I had eaten there many many times

before.  I also began to hock up phlegm a lot.  I would say I have ended up in

the ER at least a dozen times within the first couple of days after my

injections for breathing problems, etc.  I am going to take my next dose but

also keep a careful almost hour by hour log of how I feel from Xolair for at

least the first 4 days.  Also my food allergies are sooo much worse.

Last week, I was in the ER within 24 hours with the " Oh I can't breathe

feeling. "   They gave me 4 breathing treatments. 

I hope I can get off this drug somehow. 

Leigh

________________________________

From: pyle456 <jamcculloch2@...>

Sent: Sunday, July 19, 2009 1:05:19 PM

Subject: [ ] Re: FDA - Xolair Safety Review

 

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]

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.

________________________________

From: Leigh McCall-Alton <mccallalton@...>

Sent: Sunday, July 19, 2009 4:07:51 PM

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

Now I know why the pulmonologist at the Mayo clinic refused to help me take my

Xolair injection when it was due while I was there.

The Mayo Clinic participated in the original studies for Xolair and does not as

a rule prescribe it. They do not care for it at the Mayo Clinic. I trust those

doctors more than I do some wahoo pulmonologists who do not keep current.

In fact, the Mayo pulmonologist acted sort of agitated when I merely asked to

have the nurse administer it to me.

And also, a doctor at National Jewish told me that half of the patients who were

originally on Xolair at their facility are no longer on it.

Keep in mind, that National Jewish is Number 1 in pulmonology and the Mayo

Clinic is number 2.

The very first time I took Xolair, my blood pressure went up and the doctor told

my husband that it was the prednisone which I was on.

After it was in me for an hour, I could smell dust on blinds from 15 feet away.

When we went to lunch that day, I could smell odors coming

from the carpeting of the restaurant and I had eaten there many many times

before. I also began to hock up phlegm a lot. I would say I have ended up in

the ER at least a dozen times within the first couple of days after my

injections for breathing problems, etc. I am going to take my next dose but

also keep a careful almost hour by hour log of how I feel from Xolair for at

least the first 4 days. Also my food allergies are sooo much worse.

Last week, I was in the ER within 24 hours with the " Oh I can't breathe

feeling. " They gave me 4 breathing treatments.

I hope I can get off this drug somehow.

Leigh

____________ _________ _________ __

From: pyle456 <jamcculloch2@ ec.rr.com>

Sent: Sunday, July 19, 2009 1:05:19 PM

Subject: [ ] Re: FDA - Xolair Safety Review

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]

I can't tell if it is making me sick because everytime I go off of it I seem to

get worse after 4 or 5 days.

I don't know if I can go off of it at this point because my ige was 250 before I

started, then after a year it

jumped to about 850 and now I am back down to 250 again. 

Plus my immunocap food profile came back all negative whereas before I began

this medication, half were

positive. Yet, I still can not eat the foods to which I previously tested

positive. This medicine has done something odd to me.

I am going to see a new allergist and ask him to test me to hamster both by skin

test and immunocap and then we might get some

answers.

Leigh

________________________________

From: <carrie72583@...>

Sent: Sunday, July 19, 2009 9:25:16 PM

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

 

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.

____________ _________ _________ __

From: Leigh McCall-Alton <mccallalton>

Sent: Sunday, July 19, 2009 4:07:51 PM

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

Now I know why the pulmonologist at the Mayo clinic refused to help me take my

Xolair injection when it was due while I was there.

The Mayo Clinic participated in the original studies for Xolair and does not as

a rule prescribe it. They do not care for it at the Mayo Clinic. I trust those

doctors more than I do some wahoo pulmonologists who do not keep current.

In fact, the Mayo pulmonologist acted sort of agitated when I merely asked to

have the nurse administer it to me.

And also, a doctor at National Jewish told me that half of the patients who were

originally on Xolair at their facility are no longer on it.

Keep in mind, that National Jewish is Number 1 in pulmonology and the Mayo

Clinic is number 2.

The very first time I took Xolair, my blood pressure went up and the doctor told

my husband that it was the prednisone which I was on.

After it was in me for an hour, I could smell dust on blinds from 15 feet away.

When we went to lunch that day, I could smell odors coming

from the carpeting of the restaurant and I had eaten there many many times

before. I also began to hock up phlegm a lot. I would say I have ended up in the

ER at least a dozen times within the first couple of days after my injections

for breathing problems, etc. I am going to take my next dose but also keep a

careful almost hour by hour log of how I feel from Xolair for at least the first

4 days. Also my food allergies are sooo much worse.

Last week, I was in the ER within 24 hours with the " Oh I can't breathe

feeling. " They gave me 4 breathing treatments.

I hope I can get off this drug somehow.

Leigh

____________ _________ _________ __

From: pyle456 <jamcculloch2@ ec.rr.com>

Sent: Sunday, July 19, 2009 1:05:19 PM

Subject: [ ] Re: FDA - Xolair Safety Review

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]

What kind of brain surgery did you have? If your mri brain was normal, perhaps

it is a vascular problem that would need an angiogram for diagnosis.

MRIs can find all brain pathologies. When symptoms come and go, it often points

to ischemia or seizure.

Neurosurgery nurse

________________________________

From: kelijeans <kelijeans@...>

Sent: Monday, July 20, 2009 8:07:33 AM

Subject: [ ] Re: FDA - Xolair Safety Review

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

>

__________________________________________________________________

Be smarter than spam. See how smart SpamGuard is at giving junk email the boot

with the All-new . Click on Options in Mail and switch to New Mail

today or register for free at http://mail..ca

[Guest guest]

Leigh, what kind of lipomas did you have? I had one in my armpit and didn't

realize that it could be related to prednisone.

From: [mailto: ] On

Behalf Of Leigh McCall-Alton

Sent: Friday, July 17, 2009 6:09 PM

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

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

________________________________

From: uca79iii <uca79iii@...<mailto:uca79iii%40gmail.com>>

<mailto: %40>

Sent: Friday, July 17, 2009 5:01:31 PM

Subject: [ ] Re: FDA - Xolair Safety Review

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]

Where is this study? So many of us have lived with Chronic Asthma for years and

Xolair has been a life saver especially for me.  We can breathe better which

means more oxygen is getting to our vital organs, losing weight, and exercizing

more so  less stress on our heart!

For me the benefits of this therapy far out way the risks.

 

Webber

303.513.5653

melwebber22@...

 

 

________________________________

From: " nbecker@... " <nbecker@...>

" " < >

Sent: Monday, July 20, 2009 11:38:31 AM

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

 

Leigh, what kind of lipomas did you have? I had one in my armpit and didn't

realize that it could be related to prednisone.

From: [mailto: ] On

Behalf Of Leigh McCall-Alton

Sent: Friday, July 17, 2009 6:09 PM

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

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

____________ _________ _________ __

From: uca79iii <uca79iiigmail (DOT) com<mailto:uca79iii% 40gmail.com> >

<mailto:xolair_ users%40gro ups.com>

Sent: Friday, July 17, 2009 5:01:31 PM

Subject: [ ] Re: FDA - Xolair Safety Review

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]

I don't know what to do anymore.  I am going to cut back on my dose as I have

lost 20 pounds post surgery.

Plus I am not sick right now so I will take the lower dose on Thursday as

planned.  If I get weird this time,

I will quit Xolair. 

Leigh

________________________________

From: pyle456 <jamcculloch2@...>

Sent: Monday, July 20, 2009 6:26:03 AM

Subject: [ ] Re: FDA - Xolair Safety Review

 

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]

I am not sure what type I have but I had some smallish ones before Xolair.

Now I have some huge ones.

Leigh

________________________________

From: " nbecker@... " <nbecker@...>

" " < >

Sent: Monday, July 20, 2009 11:38:31 AM

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

 

Leigh, what kind of lipomas did you have? I had one in my armpit and didn't

realize that it could be related to prednisone.

From: [mailto: ] On

Behalf Of Leigh McCall-Alton

Sent: Friday, July 17, 2009 6:09 PM

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

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

____________ _________ _________ __

From: uca79iii <uca79iiigmail (DOT) com<mailto:uca79iii% 40gmail.com> >

<mailto:xolair_ users%40gro ups.com>

Sent: Friday, July 17, 2009 5:01:31 PM

Subject: [ ] Re: FDA - Xolair Safety Review

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]

I never heard that. I will have to do more research. I had my lipoma removed

over 20 years ago.

From: [mailto: ] On

Behalf Of Leigh McCall-Alton

Sent: Tuesday, July 21, 2009 1:58 PM

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

I am not sure what type I have but I had some smallish ones before Xolair.

Now I have some huge ones.

Leigh

________________________________

From: " nbecker@...<mailto:nbecker%40americanlifetv.com> "

<nbecker@...<mailto:nbecker%40americanlifetv.com>>

" <mailto: %40> "

< <mailto: %40>>

Sent: Monday, July 20, 2009 11:38:31 AM

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

Leigh, what kind of lipomas did you have? I had one in my armpit and didn't

realize that it could be related to prednisone.

From: [mailto: ] On

Behalf Of Leigh McCall-Alton

Sent: Friday, July 17, 2009 6:09 PM

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

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

____________ _________ _________ __

From: uca79iii <uca79iiigmail (DOT) com<mailto:uca79iii% 40gmail.com> >

<mailto:xolair_ users%40gro ups.com>

Sent: Friday, July 17, 2009 5:01:31 PM

Subject: [ ] Re: FDA - Xolair Safety Review

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

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