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# FDA Approves Singulair Boxed Warning
- URL: https://www.fdaweb.com/fda-approves-singulair-boxed-warning/
- Published: 2020-04-30T12:00:00.000Z
- Updated: 2026-09-14T16:13:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146694

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](http://s2027422842.t.en25.com/e/es?s=2027422842&e=328325&elqTrackId=376c7bc788024cd5a73d955f2e3dcbdc&elq=3fa74eeac52643318a0db1e33eb72715&elqaid=12344&elqat=1&ref=fdaweb.com) 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.