FDAnews Drug Daily Bulletin

Genentech Adds Black Box Warning to Xolair

July 5, 2007

Genentech has updated the labeling for its asthma drug Xolair, adding a black box warning to alert patients of the risk of anaphylaxis, the FDA announced.

According to the agency, the company also developed a new medication guide for patients warning them that Xolair (omalizumab) should only be administered under direct medical supervision. In addition, patients should be observed for an appropriate period of time following each injection.

Anaphylaxis has occurred as early as after the first dose of Xolair, but has also occurred beyond one year of beginning regular Xolair treatment, according to the FDA. Anaphylaxis can also be delayed for 24 hours or more following Xolair treatment. The reaction may include trouble breathing, chest tightness, dizziness, fainting, itching and hives and swelling of the mouth and throat.

The agency asked Genentech to add a black box warning, revise the drug’s label and provide a medication guide earlier this year. The FDA said it requested the labeling change because of the continued reports of anaphylaxis and the life-threatening potential of its delayed onset.