FDA orders stronger asthma drug warning

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FDA orders stronger asthma drug warning

Wed Feb 21, 12:10 PM ET

http://news./s/ap/20070221/ap_on_he_me/asthma_drug

WASHINGTON - 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.

The risk of anaphylaxis was known when Xolair, also called

omalizumab, was approved as an asthma treatment in 2003. But

the Food and Drug Administration ordered the drug

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.