Singulair, a widely-prescribed asthma drug, may cause serious mental health issues, according to data revealed last week by the U.S. Food and Drug Administration (FDA). FDA researchers found that the drug, also sold under the generic label montelukast, attaches to multiple brain receptors critical to psychiatric functioning.
The data support the thousands of patients and dozens of studies that have reported harmful psychiatric side effects, including depression, suicide, anxiety and aggression.
Originally manufactured by Merck, the drug is prescribed for year-round indoor allergies in patients 6 months and up, seasonal outdoor allergies in patients 2 years and up, and for preventing asthma in patients 1 year and older.
Julia Marschallinger, Ph.D., a cell biologist who has studied the drug at the Institute of Molecular Regenerative Medicine in Austria, told Reuters the new data bolster patients’ reports of harm. “It’s definitely doing something that’s concerning,” she said.
The FDA researchers presented their findings — which are preliminary and have not yet been released publicly — during a Nov. 20 meeting of the American College of Toxicology in Austin, Texas.
Their lab tests showed “significant binding” of the drug to multiple brain receptors, according to Jessica Oliphant, Ph.D., a deputy director at FDA’s National Center for Toxicological Research.
“These data indicate that montelukast is highest in brain regions known to be involved in (psychiatric effects),” Oliphant said. The FDA researchers’ findings confirmed prior research that showed montelukast penetrates the brains of rats.
The data do not show whether the binding mechanism leads directly to harmful effects in individual patients or which patients are particularly at risk, Reuters reported.
The FDA said it has no plans to update the drug’s label based on the new data. The FDA did not immediately respond to our request for comment.
According to the Asthma and Allergy Foundation of America, about 4.9 million children under 18 have asthma, making it a leading chronic disease in children. Overall, nearly 28 million — or 1 in 12 — people in the U.S. have asthma.

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