FDA Warns About Asthma Drug, Xolair
Extreme Allergic Reactions Seen in Some Patients Using Injected Drug
Feb. 21, 2007 -- The FDA is calling for a "black box" label warning for the asthma drug Xolair, alerting users it can cause potentially life-threatening allergic reactions.
The FDA issued the alert after reviewing 48 cases of anaphylaxis -- life-threatening allergic reactions -- submitted to the agency from June 2003, when Xolair was approved, through December 2005.
These cases included symptoms of bronchospasm (narrowing of airways), difficulty breathing, drop in blood pressure, fainting, hives, and swelling of the throat or tongue.
Nearly 15% of the patients required hospitalization. No deaths were reported.
The drug, which is injected, is also known by the generic name omalizumab.
It is approved for use in asthma patients aged 12 and older who have moderate to severe persistent asthma, and who have tested positive for a perennial aerial allergen -- such as pollen, grass, or dust.
The drug is a secondary treatment, recommended for those whose symptoms have not been adequately controlled with inhaled steroids.
Delayed Reaction Possible
The FDA alert warns that patients can have a delayed reaction from two to 24 hours -- or longer -- after injection.
It adds that patients who have not reacted in the past can still develop anaphylaxis following a later dose.
In about 39,500 patients who took Xolair, the FDA says anaphylaxis occurred in at least 0.1% of those treated.
The drug is currently injected in a medical setting once every two or four weeks, depending on the patient, according to an email response from the FDA.
Now, the FDA is asking health care professionals who administer Xolair to observe patients for at least two hours after giving the injection and to be prepared to manage life-threatening anaphylaxis if it occurs.
Also, patients who take Xolair should be told of the possibility of a delayed reaction and be able to recognize the signs and symptoms of anaphylaxis, the FDA says in its alert.
Patients using Xolair should carry medical contact information and an epinephrine auto-injector (EpiPen). They should also be prepared to begin treatment on themselves while they seek immediate medical attention should anaphylaxis occur.