FDA investigating link between asthma drug and heart disease

An ongoing omalizumab study prompted FDA officials to conduct a safety review of the product after interim safety data suggested increased rates of cardiovascular and cerebrovascular adverse events in patients receiving the drug compared with patients in a control group.

“FDA is not recommending any changes to the prescribing information for Xolair and is not advising patients to stop taking Xolair at this time,” according to an early communication available on the FDA website.

Disproportionate increases in ischemic heart disease, arrhythmias, cardiomyopathy, cardiac failure, pulmonary hypertension, cerebrovascular disorders and embolic, thrombotic and thrombophlebitic events in patients prescribed omalizumab (Xolair, Genetech) were among findings from the observational study, which is being conducted by the manufacturer.

The purpose of Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS) is to assess long-term safety profiles in patients receiving omalizumab after five years. Participants are aged 12 years or older, have moderate- to- severe persistent asthma and have tested positive with either a skin or blood test for an airborne allergen. Currently, 7,500 patients are enrolled; 5,000 in the omalizumab group and 2,500 in the control group.

“Until the evaluation of the EXCELS study is completed, health care providers and patients should be aware of the risks and benefits described in the prescribing information, as well as the new information from the ongoing EXCELS study that may suggest a risk of cardiovascular and cerebrovascular adverse events,” the FDA wrote.