FDA issues new warning on asthma drug Xolair

March 5, 2007

Washington - The Food and Drug Administration (FDA) has issued a new warning about omalizumab, an asthma drug marketed by Genentech as Xolair, and has requested that the manufacturer add “black box” warnings to the product’s label reflecting the risk of anaphylaxis.

Washington -

The Food and Drug Administration (FDA) has issued a new warning about omalizumab, an asthma drug marketed by Genentech as Xolair, and has requested that the manufacturer add “black box” warnings to the product’s label reflecting the risk of anaphylaxis.

The annual incidence of anaphylactic reactions is about 30 per 100,000 persons, and individuals with eczema, asthma or hay fever are at greater relative risk of experiencing them. In its recent warning, the FDA noted its research shows that about one of every 1,000 patients who take Xolair has had severe allergic reactions, online news source newsinferno.com reports.

Xolair was approved by the FDA in 2003 to treat patients with allergy-related asthma. It was previously believed that the risk of anaphylaxis was most severe within two hours of receiving the injection. The FDA issued its latest warning after receiving reports that serious allergic reactions can develop up to 24 hours after the drug is administered, and even later, in some cases.