FDA requires boxed warning for asthma and allergy drug due to neuropsychiatric events

The US Food and Drug Administration announced Wednesday it is requiring a boxed warning — the agency’s most prominent warning — for the asthma and allergy medication montelukast, sold under the brand name Singulair.

The boxed warning advises health care providers to avoid prescribing montelukast for patients with mild symptoms. It strengthens an existing warning about the risk of neuropsychiatric events, such as agitation, depression and suicidal thoughts and actions, associated with the drug.

“The incidence of neuropsychiatric events associated with montelukast is unknown, but some reports are serious, and many patients and health care professionals are not fully aware of these risks,” said Dr. Sally Seymour, director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.

“Importantly, there are many other safe and effective medications to treat allergies with extensive history of use and safety,” she said.

The FDA reached this decision after re-evaluation of the risks and benefits of montelukast compared to other available treatments that have entered the market since the drug was first approved in 1998. It determined the risks of montelukast may outweigh its benefits, especially for people with mild allergies. It recommends using montelukast only if patients have failed or cannot tolerate other therapies.

In addition to the boxed warning, the FDA is also requiring a new Medication Guide to be given to patients with montelukast prescriptions.