FDA Approves Singulair Boxed Warning

FDA has approved a new Boxed Warning for labeling for Merck’s Singulair (montelukast) and generics to increase awareness of potential mental health side effects. An agency notice says the Boxed Warning will be added to both the prescribing information and a medication guide.

The notice says FDA took the action after reviewing continued reports of neuropsychiatric events, feedback from stakeholders, and a reevaluation of the drug’s benefit/risk profile. Although the prescribing information already included warnings about mental health side effects including suicidal thoughts or actions, FDA says, many healthcare professionals and parents/caregivers still are not aware of the risk.

“The label changes will provide a stronger warning of potential risks so healthcare professionals and patients/caregivers can make informed decisions about use of the medications and look for warning signs,” FDA says.