Provider Alert! New “Black Box” warning for Singulair (montelukast) and generic formulations
Attention: PCPs, Pulmonologists, and Pharmacists Effective Date: March 20, 2020 After careful analysis of the benefits and risks, the Food and Drug Administration (FDA) has strengthened the existing warnings on potential side effects on all Singulair and generic montelukast formulations. A “Black Box” warning has been included to stress the potential for serious side effects, including but not limited to serious behavior and mood-related changes. The FDA has also advised restricting the use for allergic rhinitis (hay fever) to those not treated...
