The FDA has approved safety labeling changes for montelukast (Singulair and generics), a prescription medicine for asthma and allergies, to enhance patients', caregivers', and health care professionals' awareness of potential mental health side effects. FDA is strengthening existing warnings about the side effects by requiring a Boxed Warning to be added to the prescribing information and a medication guide for patients. This action comes after a review of continued reports of neuropsychiatric events, feedback from stakeholders, and a re-evaluation of the benefit and risk profile of the drug. For more information, read the drug safety communication issued on March 3, 2020.
NCPA
