Tuesday, July 03, 2007

Xolair (Asthma Drug) Gets Black Box Warning

The FDA finalized a strong new label warning patients and doctors about a potentially deadly allergic reaction from the asthma drug Xolair.

Xolair, given as an injection and known generically as omalizumab, is approved to treat for moderate to severe asthma (12 and older).

The previous label warned that anaphylaxis, a dangerous inflammatory reaction marked by shortness of breath, rash, wheezing and low blood pressure, occurs in about one in 1,000 patients taking the medication.

The new label, prompted by patient reports following the drug's June 2003, notes that cases of anaphylaxis were seen in roughly two out of 1,000 patients.

Source: FDA, Reuters, APand Yahoo.