In February, the FDA requested Xolair's maker, Genentech, to put the boxed warning on Xolair. Now, those warnings have been added to Xolair's packaging.
Black box warnings are the FDA's sternest warning for prescription drug labels.
The new warning notes reports of anaphylaxis in patients taking Xolair. Those reports include new users of Xolair and patients who have been taking the asthma drug for longer than one year, according to the FDA.
The FDA notes that due to the risk of anaphylaxis, Xolair should only be administered to patients under direct medical supervision by health care workers who are aware of Xolair's anaphylaxis risk, monitor patients taking Xolair, and are prepared to treat anaphylaxis.
Xolair is given by injection to patients who are at least 12 years old and have moderate-to-severe persistent allergic asthma that doesn't respond to inhaled corticosteroids.
Patients taking Xolair should be informed about their chances of developing anaphylaxis, note the FDA and Genentech.
The warning notes that signs and symptoms of anaphylaxis can include the following:
- Wheezing, shortness of breath, cough, chest tightness, trouble breathing
- Low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of impending doom
- Swelling of the throat or tongue, throat tightness, hoarse voice, trouble swallowing
- Flushing, itching, hives, or feeling warm
Patients experiencing such symptoms should seek emergency medical care.
The FDA notes three cases of anaphylaxis among 3,507 patients taking Xolair in the drug's premarketing clinical trials.
The FDA also states that in a review of 124 case reports among some 57,300 patients who took Xolair from June 2003 to December 2006, the frequency of anaphylaxis attributed to Xolair was estimated to be at least 0.2% of treated patients.