New York Attorney General Urges FDA Action On Widely Used Asthma Drug's Concerns Over Pediatric Safety

The Attorney General of New York, Letitia James, has called on the FDA to address safety risks associated with the widely used asthma and allergy medicine Singulair (montelukast). 

In a letter dated Wednesday, the state attorney general’s office emphasized the inadequacy of current warnings on the drug’s packaging, particularly concerning children.

The letter urged the FDA to conduct a comprehensive investigation into and provide warnings about the harmful neuropsychiatric side effects of Singulair. 

Citing FDA’s spokesperson Chanapa Tantibanchachai’s response on Friday, Reuters stated that the agency would directly address the concerns raised by Attorney General Letitia James. 

The letter referenced a Reuters report from the previous year, revealing thousands of reports to the FDA about patients, including children, experiencing depression, suicidal thoughts, or other psychiatric problems after taking Singulair.

The report also detailed lawsuits alleging that Merck & Co Inc MRK the drug’s manufacturer, was aware from early research that Singulair could impact the brain. Merck consumer unit spin-off Organon Inc (NYSE: OGN) now markets Singulair.

It further claimed that the company downplayed the potential for psychiatric problems in its statements to regulators.

Reuters noted that Singulair is one of the best-selling drugs in U.S. history and generated approximately $50 billion in revenue for Merck. 

The drug’s widespread use is evident from millions of prescriptions, including generic versions. The AG’s concerns bring attention to the need for a reassessment of the drug’s safety profile, particularly in the pediatric population.

Despite the FDA adding a “black box” warning to Singulair’s label in 2020, describing serious neuropsychiatric events reported by patients, the AG’s office emphasized that adverse mental health events, including suicide, continue to be widely reported disproportionately for pediatric patients. Many healthcare professionals and patients remain unaware of these potential serious side effects.

The AG urged the FDA to assess whether the risk of adverse side effects of Singulair outweigh its benefits for pediatric patients. Additionally, the office suggested notifying healthcare providers about the drug’s safety risks to minors and encouraging alternative FDA-approved medications for asthma and allergies in children and adolescents.

Photo by Minerva Studio via Shutterstock