FDA to Require Boxed Warning for Montelukast -- Update

   By Stephen Nakrosis 
 

The U.S. Food and Drug Administration on Wednesday said it is requiring a boxed warning for montelukast, which is used to treat asthma and allergy attacks.

The FDA said its warning follows a "review of available data regarding continued reports of neuropsychiatric events with montelukast, such as agitation, depression, sleeping problems, and suicidal thoughts and actions."

A boxed warning is the agency's most prominent warning, the FDA said.

Montelukast is sold under the brand name Singulair by Merck & Co. and in generic form.

The agency also said in addition to the boxed warning, a new Medication Guide is to be given to patients with each montelukast prescription.

Merck said, "We remain confident in the efficacy and safety of Singulair (montelukast sodium), a medicine that has been prescribed to tens of millions of indicated patients with asthma and allergic rhinitis since its approval more than 20 years ago. We will work with the FDA to update the labeling for Singulair. Today Merck supplies only a small portion of the overall market."

--Write to Stephen Nakrosis at [e-mail]

(END) Dow Jones Newswires

March 04, 2020 17:44 ET (22:44 GMT)

Copyright (c) 2020 Dow Jones & Company, Inc.