Potentially Deadly Allergic Reaction Occurs Twice As Often As Previously Stated On Medication's Prior Label
(Posted by Tom Lamb at DrugInjuryWatch.com)
The FDA announced on July 2, 2007 that the package insert, or label, for the asthma drug Xolair now has a black-box warning about anaphylaxis, a potentially fatal allergic reaction which can involve shortness of breath, rash, wheezing, and low blood pressure.
Xolair, which is given as an injection, was approved in June 2003 by the FDA for the treatment of moderate to severe asthma in adults and children older than 12 years of age.
The prior Xolair label's warning about anaphylaxis stated that this allergic reaction occurs in about one in 1,000 patients taking this asthma medication.
The black-box warning added to the new Xolair label states that cases of anaphylaxis were seen in roughly two out of 1,000 patients, or twice as many as the label previously warned.
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A MedWatch Safety Information Alert about Xolair issued in February 2007 and updated on July 2 by the FDA describes the risk of Xolair-associated anaphylaxis in this manner:
... new reports of serious and life-threatening allergic reactions (anaphylaxis) in patients after treatment with Xolair (omalizumab). 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.
The FDA also directed Genentech Inc., the manufacturer of Xolair, to prepare a new Medication Guide that will be given to asthma patients using Xolair when their prescription is filled by a pharmacy.