New York’s Attorney General, Letitia James, has urged the FDA to take immediate action regarding the potential side effects of Singulair, a drug commonly used to treat asthma and allergies in children. Concerns have arisen due to reports of psychiatric symptoms associated with the medication, prompting calls for enhanced warnings and safety measures.
The FDA previously issued a warning about Singulair’s psychiatric side effects in 2020 following numerous complaints from patients and parents. However, a recent investigation by The New York Times revealed that many people remain unaware of these risks, including the possibility of suicidal thoughts or behavior.
In response to these findings, Attorney General James has called for stricter safety regulations, particularly concerning the use of Singulair in children. She emphasized the importance of parents being fully informed about the potential side effects of medications prescribed to their children.
While the FDA has yet to respond directly to the Attorney General’s request, a spokeswoman indicated that the agency would address the matter. Singulair, initially a highly successful drug for Merck, continues to be widely prescribed, especially for its convenience in providing a once-daily dose for children.
Despite ongoing legal challenges, drug manufacturers maintain that they have adequately communicated the risks associated with Singulair. However, concerns persist, prompting calls for additional regulatory action to ensure patient safety.
Thomas Moore, an expert in drug safety, stressed the importance of parents remaining vigilant for any unexpected changes in their children’s behavior while taking Singulair. Meanwhile, advocates like Kammy Pany, who runs a support group for individuals affected by the drug, welcome the Attorney General’s intervention and hope for increased awareness and scrutiny of Singulair’s risks.
