A new study found that a popular asthma medication might be linked to severe mental health issues, including suicide.
Singulair, often generically known as montelukast, is an anti-inflammatory that treats allergies and asthma attacks. It was originally sold by Merck & Co. starting in 1998.
Now, recent research has shown that the drug binds itself to brain receptors and potentially impacts psychiatric functions. In other words, it might cause mental health issues and even suicide—a side effect that’s become prevalent in recent years.
In fact, according to Reuters, after receiving reports of neuropsychiatric episodes and suicides in patients who took the drug, the Food and Drug Administration (FDA) added a boxed warning to the prescribing label back in 2020, highlighting that the drug could cause suicidal thoughts or action.
“The U.S. Food and Drug Administration (FDA) is strengthening existing warnings about serious behavior and mood-related changes with montelukast (Singulair and generics), which is a prescription medicine for asthma and allergy,” the FDA wrote at the time.
“We are taking this action after a review of available information led us to reevaluate the benefits and risks of montelukast use. Montelukast prescribing information already includes warnings about mental health side effects, including suicidal thoughts or actions; however, many health care professionals and patients/caregivers are not aware of the risk,” the administration continued. “We decided a stronger warning is needed after conducting an extensive review of available information and convening a panel of outside experts, and therefore determined that a Boxed Warning was appropriate.”
After studying the link between the drug and its apparent neuropsychiatric side effects over the past few years, the FDA found “significant binding” of montelukast to brain receptors, according to Jessica Oliphant, 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, per Reuters.
However, the data doesn’t explain whether this binding actually causes harmful mental health side effects. According to Oliphant, more research is also needed to determine how the medication collects in the nervous system.
Nevertheless, this medication is “definitely doing something that’s concerning,” Julia Marschallinger, a scientist at Austria’s Institute of Molecular Regenerative Medicine, told Reuters.
For now, the FDA does not yet plan on updating the black box label.
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