Xolair Gets 'Black Box' Warning
Asthma Drug's Packaging Warns of Potentially Severe Allergic Reaction
July 3, 2007 -- The asthma drug Xolair has a new "black box" warning
about severe, potentially life-threatening allergic reaction (anaphylaxis).
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
Black box warnings are the FDA's sternest warning for prescription drug
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
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
- Wheezing, shortness of breath, cough, chest tightness, trouble
- 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
- 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