Proposed in February and approved in July, Xolair (omalizumab) will be sporting a new, upgraded black box warning as per U.S. Food and Drug Administration recommendation. The warning will emphasize that Xolair, an injectable, used to treat patients with asthma related to allergies, may cause anaphylaxis. Anaphylaxis may cause chest tightness, dizziness, fainting, trouble breathing, itching and hives and swelling of the mouth and/or throat. The FDA has also asked Genetech to revise the Xolair label and provide patients with an updated medication guide with the strengthened warning.
Xolair is indicated for the treatment of asthma patients, over the age of 12, who have severe persistent asthma and who have tested positive for a perennial aerial allergen such as polled, grass or dust. The drug is also recommended in patients whose symptoms have not be controlled by inhaled steroids.
While anaphylaxis was reported in clinical trials, postmarketing data has revealed that there is a possibility of delayed onset of anaphylaxis. The warning will include the possibility of developing anaphylaxis after any dose of Xolair, not just the first, and that the reaction may be delayed up to 24 hours.
The FDA has also recommended that patients who continue to use Xolair be educated in the use and initiation of emergency self-treatment (epinephrine auto-injector) for anaphylaxis.
[Source: FDA]
» Drug Warnings and Withdrawls for 2007 from PharmaGazette
FiercePharma has compiled a list of the top 10 drugs to have who have had approval either withdrawn or been forced to add stronger warning labels, by the FDA, with respect to their pharmaceutical products. The list is based on 2006 worl... [Read More]
Tracked on: December 5, 2007 2:41 PM | Permalink to Trackback