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.

A Merck representative couldn't immediately be reached for comment.

 

--Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

 

(END) Dow Jones Newswires

March 04, 2020 15:50 ET (20:50 GMT)

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