FDA scrutinizing safety of asthma drug

By Tom Watkins
CNN
(CNN) - The Food and Drug Administration announced Thursday it is conducting a safety review of the asthma drug Xolair after data from an ongoing study suggested an increased number of heart attacks and strokes among patients using it.

The drug, made by Genentech and co-marketed by Novartis, was approved in 2003. The ongoing five-year study that has raised the safety questions was mandated by the agency as part of its post-approval process, an agency spokeswoman said.

The data "suggest a disproportionate increase in ischemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic and thrombophlebitic events in patients treated with Xolair compared to the control group of patients not given the drug," the agency said.