WASHINGTON (Reuters) - U.S. regulators on Monday finalized a strong new label warning patients and doctors about a potentially deadly allergic reaction from Genentech Inc.’s asthma drug Xolair.
The U.S. Food and Drug Administration had proposed the so-called black box warning about anaphylaxis in February, but announced final wording of the label on Monday.
Xolair, given as an injection and known generically as omalizumab, is approved to treat adults and adolescents 12 years of age and older for moderate to severe asthma.
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.
About 15 percent of patients among those studied required hospitalization, according to the FDA.
Novartis collaborates with Genentech to market the drug.