U.S. Researchers Link Asthma Drug to Serious Mental Health Risks.
A widely prescribed asthma medication, montelukast, originally marketed by Merck & Co under the brand name Singulair, has been associated with serious mental health concerns, according to a scientific presentation reviewed by Reuters.
Researchers have found that the drug interacts with multiple brain receptors essential for psychiatric functioning.
Since its launch in 1998, Singulair became a blockbuster product, offering an alternative to inhalers with minimal side effects, as advertised. Despite being hailed as safe, its generic versions continue to be widely prescribed to millions of adults and children annually.
Growing Reports of Neuropsychiatric Episodes
By 2019, thousands of reports linking montelukast to neuropsychiatric episodes, including suicides, had accumulated in the U.S.
Food and Drug Administration (FDA) database and online forums. While such reports do not confirm causation, they serve as a basis for the FDA to investigate drug risks further.
These concerns prompted the FDA in 2020 to issue a “black box” warning for montelukast, highlighting severe risks such as suicidal thoughts and behaviors.
FDA Investigates Drug’s Mechanism
The FDA also convened an expert group to explore why montelukast might cause these psychiatric effects. Preliminary findings from their analysis, presented at the American College of Toxicology meeting, indicate that montelukast binds significantly to multiple brain receptors involved in mood, impulse control, and cognition.
Research on rats confirmed that the drug penetrates the brain, though further study is needed to understand how it accumulates in the nervous system.
Jessica Oliphant from the FDA’s National Center for Toxicological Research noted the significant presence of montelukast in brain regions associated with psychiatric functions.
While the findings suggest concerning effects, they do not definitively link the drug’s mechanisms to specific mental health outcomes in patients or identify those at highest risk.
Austrian researchers Julia Marschallinger and Ludwig Aigner supported these findings, emphasizing that the data aligns with patient reports of adverse effects.
Merck has not responded to inquiries about these findings, while Organon, the company now marketing Singulair, maintains confidence in the drug’s safety profile.
The label, they assert, provides adequate information about its benefits and risks. Meanwhile, lawsuits alleging that Merck downplayed the drug’s psychiatric risks during regulatory discussions remain unresolved.
Patient Experiences Highlight Concerns
The FDA’s database recorded 82 suicides linked to montelukast between 1998 and 2019, with 31 involving individuals aged 19 or younger.
One such case was Nick England, a 22-year-old who died by suicide in 2017 less than two weeks after starting montelukast.
His father, Robert England, recounted that Nick had no prior mental health issues and struggled with sleep shortly before his death. He expressed that the medication fundamentally altered their lives within days of its use.
Despite these reports, the FDA does not currently plan to update montelukast’s label based on the latest findings.
Researchers caution that their studies are ongoing, with many questions about the drug’s effects and risk factors remaining unanswered. However, mounting data continues to raise alarms about the psychiatric risks associated with the once-celebrated asthma drug.
U.S. Researchers Link Asthma Drug to Serious Mental Health Risks.
