The New York State Attorney General’s Office has issued a statement to the Food and Drug Administration (FDA). redouble the warning And refrain from using asthma medications.
“The New York Attorney General’s Office has written a letter encouraging the FDA to address the risks of montelukast, especially to our most vulnerable populations, namely minor children, and to protect all patients from these heartbreaking and unexpected side effects. ” said Chief Secretary Darsana Srinivasan. The Attorney General’s Office of Health Care Services said in a letter Thursday to FDA Commissioner Robert Califf.
Srinivasan said the FDA has “strengthened existing warnings about the mental and behavioral health side effects of the asthma and allergy drug montelukast (brand name Singulair) by imposing the most stringent and serious warning, a black box warning. “Almost four years have passed since then,” he said. I was given medicine. ”
Dr Srinivasan said that since the decision, an “epidemic of devastating adverse mental health events” such as depression and suicide remains “widely reported and disproportionately true for pediatric patients”. .
Srinivasan called the black box warning “inadequate” and urged federal officials to “take immediate action to prevent further unnecessary health risks to patients in the state related to the use of montelukast.” ” requested. The FDA is evaluating the risks of using montelukast in children under 18 for asthma and allergic rhinitis. ”
“We welcome any information you may wish to provide regarding the evaluation of montelukast and the actions we plan to take in relation to its use in mildly ill patients,” Srinivasan continued. “We appreciate the FDA’s consideration of this important issue.”
The Hill has reached out to Merck & Co., the maker of Singulair, and the FDA for comment.
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