ROCKVILLE, Md. A biotech drug used to treat asthma in teenagers and adults has attracted the scrutiny of the Food and Drug Administration amid study findings that it could increase the risk of heart disease.
The study suggests that Xolair (omalizumab), developed by Genentech and Novartis, could increase the risk of ischemic heart disease, arrhythmias, cardiac failure, pulmonary hypertension and other heart disease. The drug is used in patients for whom inhaled asthma drugs are inadequate.
The FDA said it was not recommending changes to Xolair’s prescribing information or advising patients not to use the drug. It also said that until it finishes evaluating the study, titled “Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma,” healthcare providers and patients should be aware of the risks and benefits described in Xolair’s prescribing information, as well as the information from the study.
As of Friday, Novartis and Genentech had not made a public statement regarding the study.