FDA slaps black box warning on popular asthma medication

March 4, 2020

The FDA announced this week that it is adding a black box warning — its strongest warning — to montelukast, a common allergy and asthma medication. 

Montelukast, sold under the brand name Singulair, was first approved in 1998. In 2008, the agency added a product labeling warning to the medication after several kinds of neuropsychiatric events were reported in conjunction with the medication. After receiving continued reports of suicidal thoughts, sleep disturbances, agitation and depression, the agency said it decided to strengthen its warning and has concluded that in cases where symptoms are mild, the risks of taking the medication could outweigh the benefits. The agency advised that some patients, particularly those with allergic rhinitis, should potentially be switched to another medication.

Singulair was first developed by Merck and in 2018, was one of the world’s top 10 asthma medications, based on revenue. 

Read the FDA press release.