After receiving reports of “serious and life-threatening” allergic reactions following the use of Xolair, the federal government has requested that a black box warning be carried on labeling for the asthma drug.
The U.S. Food and Drug Administration said on Feb. 21, 2007 that the strengthened warning for Xolair, manufactured by Genentech Inc. and administered by injection, should notify doctors and patients that the drug may cause anaphylaxis, a potentially fatal reaction.
The FDA warned that Xolair, generically omalizumab, could cause the allergic reaction after any size dosage, up to 24 hours or even longer after the injection – reactions were previously thought to have occurred within the first two hours – and “even if the patient had no allergic reaction to the first dose.”
Symptoms include trouble breathing, swelling of the mouth and throat, tightness in the chest, dizziness, fainting, itching and hives.
If you or a loved one suffered serious injury or death as a result of an allergic reaction believed to have been caused by Xolair, you may want to contact a Xolair attorney.
Omalizumab is used for the treatment of patients 12 years and older with moderate to severe persistent asthma who are allergic to perennial aeroallergens such as pollen, grass or dust and whose symptoms are not sufficiently controlled by inhaled steroids.
Allergic reactions were noted before Xolair was approved by the FDA in 2003. Reports from 39,500 patients showed that anaphylaxis occurred in about one in 1,000 patients.
The latest action by the FDA to strengthen the warning label came “due to the nature of continued reports” after Xolair went on the market, the agency said in a news release. (Read the complete news release.)
The FDA advised that doctors be prepared to manage life-threatening reactions following Xolair injections and to observe patients for at least two hours. It said patients should also carry and know how to use self-treatment for anaphylaxis.
Kline & Specter, PC, with more than 50 experienced attorneys, several of whom are also highly regarded doctors, is one of the nation's leading law firms with the ability to litigate pharmaceutical drug lawsuits. Contact a Xolair lawyer today.
