Re: Xolair Black box warning, more info?

[Guest guest]

man, i hope my dr doesn't see that article - i get my shots and sneak on out!!!

i don't want to stay 2 hours nor woudl my dr's office staff want to babysit me

for two hours (i'm their last patient...i get my shots and fly off to class).

seriously though, its such a low incidence of anaphylaxis reactions, but

genentech is mandated to report them like this, if for no other reason but to

cover their own behind. i'm sure they're seeing more people with such reactions

because more people are taking xolair now than ever before. if one of us did

have some kind of anaphylaxis emergency, i imagine most of us have an epi-pen

(or several) and are well versed in the anaphylaxis emergency situation.

personally, i'm not worried....nor will i be camping out in my drs office...

heather

(of course, there are no facts to back up what i said, its only my

opinion....feel free to wait 2 hours at your drs office if you feel you should!)

aramo2811 <aramar@...> wrote:

Saw this article. Are they really suggesting that everyone wait 2

hours in doctors' offices? There must be more specific guidance on

these rare occurrances:

MedWatch: Anaphylaxis May Occur After Taking Xolair

BETHESDA, MD -- February 21, 2007 -- FDA notified asthmatic patients

and healthcare professionals of new reports of serious and life-

threatening allergic reactions (anaphylaxis) in patients after

treatment with Xolair.

Usually these reactions occur within two hours of receiving a Xolair

subcutaneous injection. However, these new reports include patients

who had delayed anaphylaxis-with onset two to 24 hours or even longer-

after receiving Xolair treatment.

Anaphylaxis may occur after any dose of Xolair (including the first

dose), even if the patient had no allergic reaction to the first dose.

Health care professionals who administer Xolair should be prepared to

manage life-threatening anaphylaxis and should observe their Xolair-

treated patients for at least two hours after Xolair is given.

Patients under treatment with Xolair should be fully informed about

the signs and symptoms of anaphylaxis, their chance of developing

delayed anaphylaxis following Xolair treatment, and how to treat it

when it occurs. FDA has requested Genentech add a boxed warning to

the product label and to revise the label and provide a Medication

Guide for patients.

SOURCE: Food and Drug Administration

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~ A.

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

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[Guest guest]

to whom it may concern,

my son gets xolair in his drs office.. the first time he got it he had to stay

in the office for over an hour... then after each shot he had to keep stayin

there over an hour...

after the dr seen there was no reaction to the shots we was told we still have

to stay in the office now for 20 minutes. just incase there is a reaction...

most patients dont want to stay and wait... they now have a papers in all the

pts rooms now... pts getting allergy and other shots have to wait 20 minutes

now....

i think that is a good idea for that.. incase theres a problem...

Lin~~~~pittsburgh pa

many blessings for a healthy asthma free day

aramo2811 <aramar@...> wrote:

Saw this article. Are they really suggesting that everyone wait 2

hours in doctors' offices? There must be more specific guidance on

these rare occurrances:

MedWatch: Anaphylaxis May Occur After Taking Xolair

BETHESDA, MD -- February 21, 2007 -- FDA notified asthmatic patients

and healthcare professionals of new reports of serious and life-

threatening allergic reactions (anaphylaxis) in patients after

treatment with Xolair.

Usually these reactions occur within two hours of receiving a Xolair

subcutaneous injection. However, these new reports include patients

who had delayed anaphylaxis-with onset two to 24 hours or even longer-

after receiving Xolair treatment.

Anaphylaxis may occur after any dose of Xolair (including the first

dose), even if the patient had no allergic reaction to the first dose.

Health care professionals who administer Xolair should be prepared to

manage life-threatening anaphylaxis and should observe their Xolair-

treated patients for at least two hours after Xolair is given.

Patients under treatment with Xolair should be fully informed about

the signs and symptoms of anaphylaxis, their chance of developing

delayed anaphylaxis following Xolair treatment, and how to treat it

when it occurs. FDA has requested Genentech add a boxed warning to

the product label and to revise the label and provide a Medication

Guide for patients.

SOURCE: Food and Drug Administration

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

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[Guest guest]

My first shot I had to wait two hours afterwards (that was after

waiting the 20 minutes for them to mix it) and I spent my time fixing

their magazines... If this happens every month than I might start

rearranging their furniture.... (Ok my video i-pod does keep me happy

though... Nothing like listening to NPR and laughing out loud while

waiting)

Maybe they can hire me while I wait to do filing and other office

work... Can we work off our co-pays?

I know if my dr reads this they will change their policy and make us

wait the 2 hours every time... Currently they make us wait 40 minutes.

sd

(Go ----- Go away before I drop a house on you...)

[Guest guest]

next thing you know the fda will pull it off the market. sigh say I.

heather <heaven1975@...> wrote: man, i

hope my dr doesn't see that article - i get my shots and sneak on out!!! i

don't want to stay 2 hours nor woudl my dr's office staff want to babysit me for

two hours (i'm their last patient...i get my shots and fly off to class).

seriously though, its such a low incidence of anaphylaxis reactions, but

genentech is mandated to report them like this, if for no other reason but to

cover their own behind. i'm sure they're seeing more people with such reactions

because more people are taking xolair now than ever before. if one of us did

have some kind of anaphylaxis emergency, i imagine most of us have an epi-pen

(or several) and are well versed in the anaphylaxis emergency situation.

personally, i'm not worried....nor will i be camping out in my drs office...

heather

(of course, there are no facts to back up what i said, its only my

opinion....feel free to wait 2 hours at your drs office if you feel you should!)

aramo2811 <aramar@...> wrote:

Saw this article. Are they really suggesting that everyone wait 2

hours in doctors' offices? There must be more specific guidance on

these rare occurrances:

MedWatch: Anaphylaxis May Occur After Taking Xolair

BETHESDA, MD -- February 21, 2007 -- FDA notified asthmatic patients

and healthcare professionals of new reports of serious and life-

threatening allergic reactions (anaphylaxis) in patients after

treatment with Xolair.

Usually these reactions occur within two hours of receiving a Xolair

subcutaneous injection. However, these new reports include patients

who had delayed anaphylaxis-with onset two to 24 hours or even longer-

after receiving Xolair treatment.

Anaphylaxis may occur after any dose of Xolair (including the first

dose), even if the patient had no allergic reaction to the first dose.

Health care professionals who administer Xolair should be prepared to

manage life-threatening anaphylaxis and should observe their Xolair-

treated patients for at least two hours after Xolair is given.

Patients under treatment with Xolair should be fully informed about

the signs and symptoms of anaphylaxis, their chance of developing

delayed anaphylaxis following Xolair treatment, and how to treat it

when it occurs. FDA has requested Genentech add a boxed warning to

the product label and to revise the label and provide a Medication

Guide for patients.

SOURCE: Food and Drug Administration

- Join or create groups, clubs, forums & communities. Links

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Check out pics of cape the wonder dog

(because we always wonder what we'll pull out of his mouth next!)

http://snipurl.com/z18j (updated 10/06 )

If you can find a path with no obstacles, it probably doesn't lead anywhere.

~ A.

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

Want to start your own business? Learn how on Small Business.

[Guest guest]

I went to my pulmo today and we're still waiting for my approval, but he did

write me for an

epi-pen (was kind of suprised that I didn't already have one) in case of me

having a reaction

to xolair when I begin it. He actually talked to me about this article and said

that he's taking

every precaution to avoid a reaction and he even said that I would be waiting

the full two

hours so come prepared, oh boy! I will just be glad when I can walk and talk at

the same

time without gasping for air, hopefully, xolair gives me that!

Gracie

[Guest guest]

This concerns me. Not that I will have an anaphylaxis emergency, but

what will be the " over reaction " of the medical community and what

will be in their new policies and procedures in an attempt to avoid

any possibility of future legal actions.

I self inject and am concerned if this will alter " self injecting

policy " .

On Feb 21, 2007, at 8:47 PM, heather wrote:

> man, i hope my dr doesn't see that article - i get my shots and

> sneak on out!!! i don't want to stay 2 hours nor woudl my dr's

> office staff want to babysit me for two hours (i'm their last

> patient...i get my shots and fly off to class).

>

> seriously though, its such a low incidence of anaphylaxis

> reactions, but genentech is mandated to report them like this, if

> for no other reason but to cover their own behind. i'm sure they're

> seeing more people with such reactions because more people are

> taking xolair now than ever before. if one of us did have some kind

> of anaphylaxis emergency, i imagine most of us have an epi-pen (or

> several) and are well versed in the anaphylaxis emergency

> situation. personally, i'm not worried....nor will i be camping out

> in my drs office...

>

> heather

> (of course, there are no facts to back up what i said, its only my

> opinion....feel free to wait 2 hours at your drs office if you feel

> you should!)

>

> aramo2811 <aramar@...> wrote:

> Saw this article. Are they really suggesting that everyone wait 2

> hours in doctors' offices? There must be more specific guidance on

> these rare occurrances:

>

> MedWatch: Anaphylaxis May Occur After Taking Xolair

> BETHESDA, MD -- February 21, 2007 -- FDA notified asthmatic patients

> and healthcare professionals of new reports of serious and life-

> threatening allergic reactions (anaphylaxis) in patients after

> treatment with Xolair.

>

> Usually these reactions occur within two hours of receiving a Xolair

> subcutaneous injection. However, these new reports include patients

> who had delayed anaphylaxis-with onset two to 24 hours or even longer-

> after receiving Xolair treatment.

>

> Anaphylaxis may occur after any dose of Xolair (including the first

> dose), even if the patient had no allergic reaction to the first dose.

>

> Health care professionals who administer Xolair should be prepared to

> manage life-threatening anaphylaxis and should observe their Xolair-

> treated patients for at least two hours after Xolair is given.

>

> Patients under treatment with Xolair should be fully informed about

> the signs and symptoms of anaphylaxis, their chance of developing

> delayed anaphylaxis following Xolair treatment, and how to treat it

> when it occurs. FDA has requested Genentech add a boxed warning to

> the product label and to revise the label and provide a Medication

> Guide for patients.

>

> SOURCE: Food and Drug Administration

>

> - Join or create groups, clubs, forums & communities.

> Links

>

> ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

> Check out pics of cape the wonder dog

> (because we always wonder what we'll pull out of his mouth next!)

> http://snipurl.com/z18j (updated 10/06 )

>

>

> If you can find a path with no obstacles, it probably doesn't lead

> anywhere.

> ~ A.

>

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

> Want to start your own business? Learn how on Small Business.

>

>

[Guest guest]

I had my 6-month check-up this morning and got hit with all the FDA

papers. She's going to make me wait 2-hours after each shot which

doesn't bother me so much but I feel sorry for all self-injectors

that might not get that option anymore. I understand how they can

say that Xolair probably caused anaphylaxis within 2hours of the

shots, but how can they say that about the ones that happened after

24 hours, I think there are too many variables that could've caused

it after that long of time period. I had to sign off after reading

all the info from the FDA that I still wanted to continue Xolair

after being made aware of the risks, which was a no-brainer for me.

I remember life without Xolair, heck life when I'm late getting a

shot by a week is bad enough. I think if they made me wait 24 hours

in their office/hospital after each shot I'd still take it.

I'll post the info I got in the files section.

FDA Link: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01567.html

[Guest guest]

Thanks for posting that. I have called and left a message at my

doc's office that I don't care about th black box warning and please

call me if I need to sign anything.

Heck, I'll wait at the DMV for 24 hours to get the shot if that's

what I have to do.

Addy

Group Co-owner

>

> I had my 6-month check-up this morning and got hit with all the

FDA

> papers. She's going to make me wait 2-hours after each shot which

> doesn't bother me so much but I feel sorry for all self-injectors

> that might not get that option anymore. I understand how they can

> say that Xolair probably caused anaphylaxis within 2hours of the

> shots, but how can they say that about the ones that happened

after

> 24 hours, I think there are too many variables that could've

caused

> it after that long of time period. I had to sign off after

reading

> all the info from the FDA that I still wanted to continue Xolair

> after being made aware of the risks, which was a no-brainer for

me.

> I remember life without Xolair, heck life when I'm late getting a

> shot by a week is bad enough. I think if they made me wait 24

hours

> in their office/hospital after each shot I'd still take it.

>

> I'll post the info I got in the files section.

>

>

>

> FDA Link: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01567.html

>