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Singulair and Montelukast to Require Black Box Warning

Singulair and Montelukast to Require Black Box Warning

Generic Montelukast and Singulair Will Now Carry Stronger Warning Label About Possible Side Effects

Food and Drug Administration today announced that it is requiring a boxed warning - the agency's most prominent warning - for montelukast (sold under the brand name Singulair and in generic form) to strengthen an existing warning about the risk of neuropsychiatric events associated with the drug, which is used to treat asthma and allergic rhinitis (hay fever).

FDA to Require Boxed Warning for Montelukast -- Update

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,... https://www.marketscreener.com/MERCK-AND-COMPANY-13611/news/FDA-to-Require-Boxed-Warning-for-Montelukast-Update-30110633/

FDA Requires Boxed Warning For Singulair Due To Neuropsychiatric Events

(CNN) The US Food and Drug Administration announced Wednesday it is requiring a boxed warning the agencys most prominent warning for asthma and allergy medication montelukast, sold under the brand name Singulair. The boxed warning advises health care providers to avoid prescribing montelukast for patients with mild symptoms.
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Singulair/Monteleukast gets black box warning due to suicidal side effects

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FDA Announces New Warnings For Popular Allergy Medication

PITTSBURGH (KDKA) The Food and Drug Administration has strengthened existing warnings for a prescription medication for asthma and allergies. The warnings are for Montelukast, known under the trade name of Singulair. Montelukast/Singulair prescribing information already includes warnings about ...

FDA: Asthma drug Singulair to get 'black box' warning

Asthma and allergy drug montelukastsold as a generic and under the brand name Singulairwill get a "boxed warning" over potential ties to neuropsychiatric effects, the U.S. Food and Drug Administration announced Wednesday. The drug has long carried a warning that it has been linked with an increased risk for "agitation, depression, sleeping problems, and suicidal thoughts and actions," the FDA said in a statement.
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