New York Attorney General Demands Enhanced Safety Labeling for Pediatric Use of Singulair

1. The New York Attorney General, Letitia James, urgently requests the U.S. Food and Drug Administration (FDA) to take action to address the potential dangers of the asthma and allergy drug Singulair, specifically for children.
2. Singuliar, also known by its generic name montelukast, has been linked to harmful behavioral and mental health issues, including aggression, depression, and suicide, among pediatric users.
3. Approximately 1.6 million children under the age of 18 are among the 12 million individuals prescribed Singulair.
4. Studies have found increased rates of generalized anxiety disorder, insomnia, and antidepressant prescriptions in patients using Singulair.
5. Despite a black box warning added by the FDA in 2020, adverse mental health events, including suicide, continue to be widely reported for pediatric patients.
6. The Attorney General suggests the FDA should issue a new Drug Safety Communication, send a Dear Health Care Provider letter, evaluate all available information, and possibly impose risk evaluation and mitigation strategies (REMS).
7. The call for action comes due to the perceived inadequacy of current warnings on the drug's packaging, especially for children, and reports indicating many healthcare professionals and patients are unaware of these potential serious side effects.
8. The drug's manufacturer, Merck & Co Inc., and now its successor, Organon Inc., have faced criticism for allegedly being aware of the potential brain impacts of Singulair yet downplaying the associated risks.
9. Singulair is considered one of the best-selling drugs in U.S. history, generating around $50 billion in revenue for Merck.
10. The Attorney General stresses the importance of informing parents and guardians about the potential side effects to make well-informed decisions regarding their children's health.