FDA to Require Boxed Warning for Montelukast
March 04 2020 - 4:05PM
Dow Jones News
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)
Copyright (c) 2020 Dow Jones & Company, Inc.
Merck (NYSE:MRK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Merck (NYSE:MRK)
Historical Stock Chart
From Apr 2023 to Apr 2024