The New York attorney general emphasized the urgency for the Food and Drug Administration to issue new alerts to doctors and patients regarding the harmful effects of Singulair for children.
The attorney general stated that the current warnings about the drug’s psychiatric side effects were inadequate.
In a letter, Letitia James, the attorney general, also urged the federal agency to consider advising against prescribing Singulair, an asthma and allergy medication, to children.
Many patients and parents have raised concerns with the F.D.A. regarding symptoms of anxiety, rage, hallucinations, and other psychiatric issues that they have associated with the drug, also known as montelukast.
The information from various sources, including an impactful F.D.A. hearings in 2019 and instances documented in medical literature, prompted the F.D.A. in 2020 to issue its strongest caution on how the drug should be used.
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However, a review conducted by The New York Times discovered that individuals still claimed they were unaware of the potential side effects, such as suicide or suicide attempts, when using the medication themselves or administering it to their children.
Ms. James referenced The Times’s article and urged the F.D.A. to enforce stricter safety regulations for the drug, especially for children.
“Parents and guardians deserve to have all the information about a medication’s possible side effects when deciding on their children’s health,” stated Ms. James on Thursday. “The dangers of using Singulair are too serious to not have a clear warning.”
Singulair’s Continued Popularity Among Doctors for Asthma Treatment
When requested for a comment, Chanapa Tantibanchachai, a spokeswoman for the FDA, mentioned that the agency would provide a direct response to Ms. James.
The medication was a huge success for Merck during its initial years. Now a popular choice among doctors, particularly because children can easily take a chewable pill once a day instead of managing an inhaler.
This medication is not a steroid, making it a viable choice for individuals with asthma. In 2022, over 12 million individuals obtained a prescription for the medication, as per information shared with The Times by Komodo Health, a medical data company.
Merck has been standing by the drug in court, but previously directed inquiries to a generic manufacturer, Organon, which stated that the risks of the drug had been clearly communicated to patients and healthcare providers.
Over the years, the FDA has defended its actions regarding the drug’s availability in light of safety concerns. The agency continues to research and keep an eye on the drug, but conducting studies large enough to identify rare events associated with the drug, such as suicide, was not possible.