Quoted from http://www.cnn.com/2009/HEALTH/07/16/asthma.drug.xolair/
FDA scrutinizing safety of asthma drug Xolair
Thu July 16, 2009
By Tom Watkins
(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 who use it.
The drug, made by Genentech and co-marketed by Novartis, was approved in 2003. The study, which started in 2004 and is slated to end in 2012, was mandated by the agency as part of its post-approval process.
The data "suggest a disproportionate increase in ischemic heart disease, arrhythmias ... cardiac failure" and other conditions "in patients treated with Xolair compared to the control group of patients not given the drug," the agency said.
Xolair is approved for use by adults and adolescents (12 and older) with moderate to severe persistent asthma who react to a perennial airborne allergen and whose symptoms are not well controlled with inhaled corticosteroids.
The study that raised the questions is called "Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma" -- EXCELS for short. It counted outcomes among some 5,000 Xolair-treated patients and compared them with a control group of about 2,500 patients who were not taking Xolair.
The FDA did not recommend changes to the prescribing information and is not advising patients to stop taking Xolair.