The U.S. Food and Drug Administration has begun a safety review of the asthma drug Xolair (omalizumab) after reports of an increased risk of heart attack, abnormal heart rhythm, heart failure and stroke, the agency said Thursday.
Early results from the what’s known as the EXCELS trial (Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma) spurred the investigation, the FDA said. The results indicate that Xolair boosts the risk of heart problems among users of the drug compared with nonusers.
The data from the trial was supplied to the FDA by Genentech, the maker of Xolair. The trial includes some 5,000 people taking the drug and an additional 2,500 people who are not using Xolair, according to the FDA.
Xolair, which is given by injection, is intended for people whose asthma is not controlled by inhaled corticosteroids.
Currently, the FDA is not telling people using Xolair to stop taking the drug. However, the agency believes that patients and doctors should be aware of potential problems when taking Xolair, including the possible risk for heart attack and stroke.