FDA to Require Boxed Warning for Montelukast -- Update
March 04 2020 - 5:59PM
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.
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 stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
March 04, 2020 17:44 ET (22:44 GMT)
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