The attorney general of New York said on Thursday that the present warnings regarding the drug’s psychological side effects were insufficient and encouraged the Food and Drug Administration to “engage in quick action” and update cautions to physicians and patients about the harmful effects of Singulair for youngsters.
Letitia James, the attorney general, also urged the federal government to think about banning the medication of asthma and allergy medication Singulair to kids in a letter.
The medicine, referred to as montelukast in generic form, has been connected to hundreds of patient and parent complaints to the FDA regarding psychological disorders such as delusions, anxiety, and anger.
These allegations, together with a tearful FDA hearing in 2019 and incidents mentioned in medical journals, prompted the FDA to issue their strictest warning on how to use the medicine in 2020.
However, a New York Times investigation revealed that individuals kept claiming they were unaware of the medication’s potential negative effects—which included suicide or attempted suicide—when they used it or offered it to their kids.
Citing an article from The Times, Ms. James demanded that the FDA “apply new, stricter safety regulations for the drug,” with a focus on youngsters.
In a statement released on Thursday, Ms. James stated that “parents and caretakers have the privilege to be completely aware of a medication’s possible negative effects when making decisions concerning their children’s health.” “Taking Singulair carries risks that are far too serious to be disclosed without a strong warning.”
When contacted for comment on Thursday, F.D.A. spokesman Chanapa Tantibanchachai stated that the organization would address Ms. James immediately.
In its initial years, the drug was a big hit for Merck. Even though it is now generic, doctors still recommend it since kids can consume a chewing pill every day instead of constantly carrying an inhaler. Another reason it is thought to be a possibility for those with asthma is that it is not a steroid.