Re: Flogging a dead pony: FDA Update on Black Box Warning

[Guest guest]

As advised by my Doctor, I carry an Epi-Pen right in my pocket when

I go to get my Xolair shots. Later, it goes into my brief case at

work and I have one at home. If anaphylaxis sets in I'll have no

hesitation to give myself an epinephrine jab. So far I've not had

the slightest sensation or symptoms of anaphylxis. I'm approaching

one year on Xolair with two injections every two weeks.

I'm glad the FDA sounds the alert so I'm on the lookout if something

happens. Be Prepared, they say!

>

> Nan here....the FDA site is a pain to navigate, so I cut and paste.

>

> http://www.fda.gov/cder/drug/InfoSheets/HCP/omalizumabHCP.htm

>

> Boy, is the FDA hyping up " the shot should only be giving in

medical settings " .

> I wonder how many doctors this is going to scare.

>

> Nan-->who, I guess, should be grateful that I can get the

injection at

> the doctor's office, instead of the infusion center.

>

>

> ---------FROM FDA WEB

> SITE---------------------------------------------------------------

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

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

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

>

> FDA ALERT [2/2007, updated 7/2007]: This Alert highlights

important

> revisions to the full prescribing information for Xolair. The

updated

> full prescribing information for Xolair (July 2007) includes a new

> Boxed WARNING, updated WARNINGS, PRECAUTIONS, and ADVERSE

> REACTIONS--Postmarketing Spontaneous Reports. A New Medication

Guide

> [PDF] about the risk of anaphylaxis following administration of

Xolair

> is to be distributed with each dose of Xolair.. These revisions

> address the risk of anaphylaxis following treatment with Xolair.

The

> implications of this new labeling for healthcare professionals who

> administer Xolair are summarized below. Xolair is approved to

treat

> adults and adolescents (12 years of age and above) with moderate to

> severe persistent asthma who have a positive skin test or in vitro

> reactivity to a perennial aeroallergen and whose symptoms are

> inadequately controlled with inhaled corticosteroids.

>

> Recommendations and considerations for healthcare professionals:

>

> Anaphylaxis, presenting as bronchospasm, hypotension, syncope,

> urticaria, and/or angioedema of the throat or tongue has been

reported

> to occur after administration of Xolair.

>

> * Anaphylaxis has occurred as early as after the first dose of

> Xolair, but also has occurred beyond one year after beginning

regular

> treatment with Xolair.

> * Due to the risk of anaphylaxis, Xolair should only be

> administered to patients in a healthcare setting under direct

medical

> supervision by providers who:

> o Are prepared to identify and treat anaphylaxis after

> Xolair treatment

> o Know anaphylaxis can occur after any dose of Xolair,

even

> if past doses were well tolerate

> o Know the onset of anaphylaxis can be delayed after

administratiom

> o Observe patients for an appropriate period of time

> following each Xolair injection

> o Have trained personnel, medications, and equipment for

the

> treatment of life-threatening anaphylaxis available when

administering

> Xolair. Medical personnel administering Xolair should be prepared

to

> recognize and treat anaphylaxis

> * Inform patients receiving Xolair treatment of their chance of

> developing anaphylaxis (including anaphylaxis delayed for 24 hours

or

> more following Xolair treatment) and how to treat it if it occurs.

> The " Information for the patient " section below provides more

detail.

> o Give patients the Medication Guide [PDF] for Xolair and

> instruct them to read it before starting treatment with Xolair and

> before each subsequent dose

> o Inform patients of the signs and symptoms of

anaphylaxis

> o Instruct patients to seek immediate care should such

symptoms occur

> * Discontinue Xolair in patients who experience a severe

> hypersensitivity reaction

> * Report patients who have adverse events including

anaphylaxis or

> hypersensitivity to the FDA's MedWatch program (see reporting

> information at the bottom of this page)

> * Periodically reassess the need for continued Xolair therapy

> based upon the patient's disease severity and level of asthma

control

>

> Information for the patient: Physicians who are prescribing Xolair

> should discuss with their patients:

>

> * Because of the chance of anaphylaxis with Xolair, patients

> should receive Xolair treatment in a doctor's office and be

observed

> for an appropriate period of time after each treatment

> * Anaphylaxis can be serious and life-threatening. Signs and

> symptoms of anaphylaxis include:

> o Wheezing, shortness of breath, cough, chest tightness,

or

> trouble breathing

> o Low blood pressure, dizziness, fainting, rapid or weak

> heartbeat, anxiety, or feeling of " impending doom "

> o Swelling of the throat or tongue, throat tightness,

hoarse

> voice, or trouble swallowing

> o Flushing, itching, hives, or feeling warm

> * Anaphylaxis can occur with the first dose or after any dose

of Xolair

> * Anaphylaxis can begin 24 hours or more after Xolair treatment

> * To tell your healthcare provider right away if you have

symptoms

> of anaphylaxis after receiving Xolair, and

> * To get emergency medical attention immediately if any

symptoms

> of anaphylaxis appear after leaving the doctor's office

> * Carry medical contact information and be fully prepared to

begin

> treatment for anaphylaxis

> * You should not receive Xolair if you have ever had an

allergic

> reaction to a Xolair injection

> * Do not change or stop taking any of your other asthma

> medications unless otherwise instructed to do so by a healthcare

> provider

> * Patients may not see immediate improvement in their asthma

after

> beginning Xolair therapy

>

> Background Information and Data

>

> Clinical trial experience

> Three cases of anaphylaxis were identified among the 3,507 subjects

> exposed to Xolair in premarketing clinical trials. Reports of

> anaphylaxis were based on investigator judgment in relationship to

the

> study drug. The time to onset of anaphylaxis after administration

of

> Xolair in these three patients was:

>

> * 90 minutes in two patients

> * 2 hours in one patient.

>

> In addition to these three cases, there were two cases of dyspnea

> and/or wheezing with urticaria that were not reported as

anaphylaxis,

> but met the diagnostic criteria for anaphylaxis that were used to

> define the postmarketing cases (see below). One of these patients

> developed localized urticaria, dyspnea, coughing, and wheezing

after

> receiving the first dose of Xolair. The second patient experienced

> urticaria, dyspnea, and hot flushes the day after receiving the

third

> dose of Xolair.

>

> Postmarketing Cases

> Based on a review of 124 spontaneous case reports and an estimated

> exposure of about 57,300 patients from June 2003 to December 2006,

the

> frequency of anaphylaxis attributed to Xolair use was estimated to

be

> at least 0.2% of treated patients. Because adverse reactions are

> reported voluntarily, the actual frequency of anaphylaxis and

percent

> of patients with onset during specific time periods after

> administration of Xolair may differ from these estimates and this

case

> series. The case definition of anaphylaxis used for this review

> included either skin or mucosal tissue involvement, and, either

airway

> compromise, and/or reduced blood pressure with or without

associated

> symptoms; and a temporal relationship with Xolair administration

with

> no other identifiable cause.

> Symptoms and signs of anaphylaxis in these reported cases included

> bronchospasm, hypotension, syncope, urticaria, angioedema of the

> throat or tongue, dyspnea, cough, chest tightness, cutaneous

> angioedema, and generalized pruritus. Some patients required

oxygen

> and parenteral medications. Pulmonary involvement, including

> bronchospasm, dyspnea, cough, or chest tightness, was reported in

89%

> of the cases. Hypotension or syncope was reported in 14% of cases.

> Fifteen percent of patients required hospitalization. A previous

> history of anaphylaxis unrelated to Xolair was reported in 24% of

the

> cases. The list below provides information about the time to

onset of

> anaphylaxis following Xolair administration for these patients.

> • 30 minutes or less 35%

> • Greater than 30 to 60 minutes 16%

> • Greater than 60 to 90 minutes 2%

> • Greater than 90 to 120 minutes 6%

> • Greater than 2 hours to 6 hours 5%

> • Greater than 6 to 12 hours 14%

> • Greater than 12 to 24 hours 8%

> • Greater than 24 hours (up to 4 days) 5%

> • Unknown 9%

>

> Of the reported cases of anaphylaxis, 39% occurred after the first

> dose of Xolair, 19% occurred with the second dose, 10% occurred

with

> the third dose, and the rest after subsequent doses. One case

> occurred after 39 doses (after 19 months of continuous therapy,

> anaphylaxis occurred when treatment was restarted following a 3

month

> gap). Twenty-three patients who experienced anaphylaxis were

> re-challenged with Xolair; among them, 18 had a recurrence of

similar

> symptoms of anaphylaxis. Four patients who experienced urticaria

and

> not anaphylaxis were re-challenged with Xolair and developed

> anaphylaxis upon re-challenge.

>

> ----------------------------------------END------------------------

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

>

[Guest guest]

Hello

Newbie just on third shot, and a question is xolair a lifelong shot since

Doug you are on your 105th???

I can't imagine-- but like I said I am on my third...Louise

************************************** See what's free at http://www.aol.com.

[Guest guest]

>

> As advised by my Doctor, I carry an Epi-Pen right in my pocket when

> I go to get my Xolair shots. Later, it goes into my brief case at

> work and I have one at home. If anaphylaxis sets in I'll have no

> hesitation to give myself an epinephrine jab. So far I've not had

Since the black box warning, my doctor requires me to bring my Epi pen

to my injections also and keep it close for 2 hours. I am going for

my 104th and 105th shots here in a few minutes and have never had any

problems either. But just in case, I want to be safe.

Doug

Group founder

[Guest guest]

WOW Doug, hoping for that positive out come for me-- have not seen the Mecca

yet.. Thanks for the email, Louise

************************************** See what's free at http://www.aol.com.

[Guest guest]

>

> Hello

> Newbie just on third shot, and a question is xolair a lifelong shot

since

> Doug you are on your 105th???

> I can't imagine-- but like I said I am on my third...Louise

>

>

My asthma has been a lifetime condition. I am told that yes, xolair is

a lifetime medication just like my neb and inhalers.

The POSITIVE thing is that now thanks to Xolair, for many of us, Pred

and it's horrible side effects is NO LONGER a lifetime medication.

Doug

Group founder

[Guest guest]

>

> WOW Doug, hoping for that positive out come for me-- have not seen

the Mecca

> yet.. Thanks for the email, Louise

>

Remember.....Xolair is not a quick acting medication like your inhaler

or a large dose of Prednisone. It takes some people a few weeks to

see any results. It took me a full year. After I was on Xolair for

about a year and a half, I was able to completely get off Prednisone.

Also, we must remember that there is no cure for asthma; only

medications that keep our symptoms under control. Xolair is just the

latest weapon in our fight to breathe.

Doug

Group founder

[Guest guest]

I don't quite understand the reason for this latest warning since

there was one in Feb. Is it because of the increase in cases of

anaphylaxis? Or is it to stop home injectors? It sounds kind've

like they're trying to warn doctor office staff about it more. I

would expect that more cases would come to light with more users but

then the same can happen with any med.

I'm still injecting at home - my 8th " round " of shots later this week

(375 mgs every 2 weeks - that's 3 shots at a time) but I do keep the

epi-pen around for first 24 hours and try to keep my hubby awake for

2 hrs after my injection.

When anaphylaxis occurs is it gradual or do people just stop

breathing and fall over? No breathing or swelling that I can tell so

far for me.

>

> As advised by my Doctor, I carry an Epi-Pen right in my pocket when

> I go to get my Xolair shots. Later, it goes into my brief case at

> work and I have one at home. If anaphylaxis sets in I'll have no

> hesitation to give myself an epinephrine jab. So far I've not had

> the slightest sensation or symptoms of anaphylxis. I'm approaching

> one year on Xolair with two injections every two weeks.

>

> I'm glad the FDA sounds the alert so I'm on the lookout if

something

> happens. Be Prepared, they say!

>

[Guest guest]

Technically, an anaphylactic reaction can be as mild as itching all

over (not just where the allergen exposure occurred like at the site

of a bee sting)or hives and as severe as what we're all pretty much

familiar with, difficulty breathing, wheezing and dangerous drop in

blood pressure leading to loss of consciousness. It can start with

only generalized itching or hives and not progress in the mildest

cases, or quickly progress to severe difficulty breathing and passing

out due to a severe drop in blood pressure. It is the most severe

kind that is life threatening but if you have a mild case it's not

possible to predict whether or not it will worsen, you just have to

observe. Because of that, you are safest haveing an anaphylactic

reaction in a medical setting.

That's the reason for the black box warning. Even though anaphylactic

reactions are due to Xolair are rare, they definitely happen and all

but one of them that happened during the clinical trial happened

again when Xolair was given again. I think the reason for the most

recent warning is that it includes specific information to be given

to patients. My guess is that more anaphylactic reactions occurred,

perhaps outside of medical settings, after the first warning was

issues in February and the FDA felt the need to reissue the warning

with additional info included.

Several members of this discussion board have mentioned that they

keep an epi pen at hand after their Xolair injections and one person

(?Doug) mentioned that their doc requires them to keep two on hand.

The reason to keep two available is that each epi injection can wear

off within 2-5 minutes; it's only a very temporary fix. In general,

if you need to use your epi pen, you need to get to an ER

immediately, with someone else driving or by ambulance. This is both

because the reaction may quicly return and worsen and because the epi

pen itself can cause a rapid heart beat that, in some cases, can

become dangerous, especially if two injections are given.

Having said all that, it's true that most anaphylactic reactions are

the milder kind. But the unpredicability of where it goes next is a

big problem. In my mind, better safe than sorry.

Fran

> >

> > As advised by my Doctor, I carry an Epi-Pen right in my pocket

when

> > I go to get my Xolair shots. Later, it goes into my brief case

at

> > work and I have one at home. If anaphylaxis sets in I'll have no

> > hesitation to give myself an epinephrine jab. So far I've not

had

> > the slightest sensation or symptoms of anaphylxis. I'm

approaching

> > one year on Xolair with two injections every two weeks.

> >

> > I'm glad the FDA sounds the alert so I'm on the lookout if

> something

> > happens. Be Prepared, they say!

> >

>