FDA adds boxed warning to Merck’s asthma med Singulair

Citing a need to strengthen the existing warning about the risk of neuropsychiatric events associated with the drug, the FDA is now requiring a boxed warning in the labeling of Merck’s (MRK +4.6%) asthma med Singulair (montelukast sodium) and generic versions of the leukotriene receptor antagonist.

The agency says the precise incidence of said events is unknown but there have been reports of serious cases. It is also requiring a new medication guide to be given to patients with each prescription.

https://seekingalpha.com/news/3548701-fda-adds-boxed-warning-to-mercks-asthma-med-singulair