FDA Orders Stronger Warnings For Xolair

Asthma Drug Reported To Cause Delayed Life-Threatening Reaction In Some Patients

(AP)  The government ordered stronger label warnings for an injected asthma medication Wednesday because of reports some patients taking the drug, marketed as Xolair, had suffered a delayed and potentially life-threatening reaction known as anaphylaxis.

A patient experiencing anaphylaxis might have trouble breathing, feel tight in the chest, have swelling in the mouth and throat, suffer dizziness or feel faint, or have itching and hives.

But the Food and Drug Administration ordered the drug's manufacturer, Genentech, Inc., to strengthen the label warnings because of reports of patients having a delayed reaction of anaphylaxis or reacting to a subsequent dose even when they had no problems after a first dose.

The new warning says:

Doctors should observe patients for at least two hours after the drug is injected and be ready to manage a potentially life-threatening reaction.

Anaphylaxis can occur even if a patient did not react to a previous Xolair injection.
Anaphylaxis can occur up to 24 hours after the injection is given.

Patients using Xolair should be prepared for to treat themselves for anaphylaxis in emergency situations.



© MMVII The Associated Press. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed.

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Add a Comment

by drinuk February 22, 2007 5:46 AM PST

It's gotta be bad when the FDA comes out with a warning against a drug company but why not pull it off the shelf ? Why was it approved in the first place? Yet another load of poison which got through to public use on the say so of the manufacturer. Did the FDA check this product ? ANSWER PLEASE !

Reply to this comment

by john3535-2009 February 22, 2007 8:59 AM PST

DRinUK... please understand the facts before you "shoot off at the hip!" First of all, Xolair has revolutinized asthma care. It has saved so many people's lives. People that were unable to walk because of their asthma are free to walk again. Xolair is indicated for moderate to serve asthma. The rate of anaphlyaxis is .1% in Xolair treated patients and 5% in patients receiving allergy shots. Allergy shots have been around for 50 years. The FDA is not going to approve Xolair unless it provides clinical benefit for patients. So... get your facts straight and learn, learn and learn before you open your mouth!

Reply to this comment

by drinuk February 22, 2007 11:58 AM PST

And whilst you are opening your mouth John, tell us just how many people 1% represents ?
Just how serious were the side effects and did anyone die ? You obviously have all the figures at hand, so please tell us, the public.
Furthermore, I do not need you to tell me anything about Asthma, I have suffered seriously for over sixty years, I need no preaching from you, thank you. Big Pharma simply provides dependency and comfort, there 'aint no cash in curing folks. One simply as to consider carefully the so called approval by the FDA of Aspartame to Learn and understand that the health of the public is hardly a consideration when the financial stakes are so high.

Reply to this comment

by mpinjs February 22, 2007 1:31 PM PST

Dear DRinUK,
With all due respect, "1%" is not what John stated, if you read his comment correctly, or were familiar with the Xolair package insert, he stated ".1%" (point one percent) which is ONE TENTH of one percent. This represented 3 in over 4000 patients. The Xolair PI currently states: "Anaphylaxis has occurred within 2 hours of the first or subsequent administration of Xolair in 3 ( 0.1%) patients without other identifiable triggers." No fatal anaphylactic reactions have been reported to date. For over 3 years, Xolair has provided relief, improved quality of life and increased productivity for thousands of asthma sufferers. Having "suffered for 60 years" from asthma yourself, I should think you'd be inclined to try such a revolutionary treatment rather than bash an industry who works tirelessly to create new and effective treatments. Genentech & Novartis have responsibly reported information related to the use of Xolair in order to keep the public informed. Mello out.

Reply to this comment

by jimbo505 February 22, 2007 3:03 PM PST

This is some scary stuff!

Reply to this comment

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[drinuk]

It's gotta be bad when the FDA comes out with a warning against a drug company but why not pull it off the shelf ? Why was it approved in the first place? Yet another load of poison which got through to public use on the say so of the manufacturer. Did the FDA check this product ? ANSWER PLEASE !

[john3535-2009]

DRinUK... please understand the facts before you "shoot off at the hip!" First of all, Xolair has revolutinized asthma care. It has saved so many people's lives. People that were unable to walk because of their asthma are free to walk again. Xolair is indicated for moderate to serve asthma. The rate of anaphlyaxis is .1% in Xolair treated patients and 5% in patients receiving allergy shots. Allergy shots have been around for 50 years. The FDA is not going to approve Xolair unless it provides clinical benefit for patients. So... get your facts straight and learn, learn and learn before you open your mouth!

[drinuk]

And whilst you are opening your mouth John, tell us just how many people 1% represents ?
Just how serious were the side effects and did anyone die ? You obviously have all the figures at hand, so please tell us, the public.
Furthermore, I do not need you to tell me anything about Asthma, I have suffered seriously for over sixty years, I need no preaching from you, thank you. Big Pharma simply provides dependency and comfort, there 'aint no cash in curing folks. One simply as to consider carefully the so called approval by the FDA of Aspartame to Learn and understand that the health of the public is hardly a consideration when the financial stakes are so high.

[mpinjs]

Dear DRinUK,
With all due respect, "1%" is not what John stated, if you read his comment correctly, or were familiar with the Xolair package insert, he stated ".1%" (point one percent) which is ONE TENTH of one percent. This represented 3 in over 4000 patients. The Xolair PI currently states: "Anaphylaxis has occurred within 2 hours of the first or subsequent administration of Xolair in 3 ( 0.1%) patients without other identifiable triggers." No fatal anaphylactic reactions have been reported to date. For over 3 years, Xolair has provided relief, improved quality of life and increased productivity for thousands of asthma sufferers. Having "suffered for 60 years" from asthma yourself, I should think you'd be inclined to try such a revolutionary treatment rather than bash an industry who works tirelessly to create new and effective treatments. Genentech & Novartis have responsibly reported information related to the use of Xolair in order to keep the public informed. Mello out.

[jimbo505]

This is some scary stuff!