FDA Adds Boxed Warning to Singulair Regarding Behavior, Mood-Related Changes
March 5, 2020
WASHINGTON, D.C. — The Food and Drug Administration says it is adding a boxed warning to Merck's asthma and allergy drug Singulair (montelukast) and generic equivalents regarding serious behavior and mood-related changes.
In a March 4 MedWatch Safety Alert, the agency explained that it decided “a stronger warning is needed after conducting an extensive review of available information and convening a panel of outside experts.”
“We are taking this action after a review of available information led us to reevaluate the benefits and risks of montelukast use,” the alert says. “Montelukast prescribing information already includes warnings about mental health side …