A widely prescribed asthma drug originally sold by Merck & Co. may be linked to serious mental health problems for some patients, the government says, according to scientific publications reviewed by Reuters. discovered by researchers.
US researchers have discovered that the drug, sold under the brand name Singulair and commonly sold as montelukast, binds to multiple brain receptors important for psychiatric function.
Singulair has been a blockbuster product for Merck since its launch in 1998, providing symptom relief in tablet form as an alternative to inhalers. The company said in early advertising that side effects were very benign.looks like a sugar pill” Meanwhile, Label said the distribution in the brain was “minimal.” Generic versions are still prescribed to millions of adults and children each year.
But by 2019, thousands of reports of neuropsychiatric symptoms, including dozens of suicides, in patients prescribed the drug had piled up on internet forums and on the U.S. Food and Drug Administration's tracking system. These “adverse event” reports do not prove a causal relationship between the drug and the side effect, but are used by the FDA to determine whether a drug's risks warrant further study.
After years of analysis, reports and new scientific research led the FDA in 2020 to add a “black box” warning to montelukast prescription labels, warning of serious mental health risks such as suicidal thoughts and actions. uttered.
The agency also convened an internal expert group around the same time to investigate why the drug could cause neuropsychiatric side effects.
The group's findings, which are preliminary and have not previously been reported or published, were presented to a limited audience Wednesday at the American Society of Toxicology meeting in Austin, Texas.
The FDA said it has no plans to update drug labels based on data from the recital.
“What I'm concerned about”
Montelukast's behavior appears to be similar to other drugs known to have neuropsychiatric effects, such as the antipsychotic drug risperidone, according to FDA slides reviewed by Reuters. The FDA cautioned that the study is ongoing and the results have not yet been finalized.
When adding the black box, the FDA cited research by Julia Marshalinger and Ludwig Aigner of Austria's Institute for Molecular Regenerative Medicine.
Two scientists told Reuters on Thursday that new data shows there are significant amounts of montelukast in the brain. The receptors involved play a role in controlling mood, impulse control, cognition and sleep, among other functions, the researchers said.
The study does not show whether the binding mechanism directly causes harmful effects in individual patients or who is particularly at risk, the two scientists said. But Marshallinger said the new data supports reports from people who have reported suffering from side effects.
“It's definitely doing something concerning,” she said.
A Merck representative did not respond to questions. Organon, the Merck spinoff that currently markets Singulair, said in a statement that it is confident in the drug's safety profile.
“Singulair's product label provides pertinent information regarding Singulair's benefits, risks, and reported side effects,” the company said.
Reuters reported last year The FDA says it has received thousands of reports of patients, many of them children, experiencing depression, suicidal thoughts and behaviors, and other mental illnesses after starting to use montelukast.
Through 2019, the FDA had tallied 82 suicides related to Singulair and its generic versions reported in its adverse event database since 1998. At least 31 of these reports involved individuals under the age of 19.
Robert Englund's 22-year-old son Nick committed suicide less than two weeks after starting montelukast in 2017. Ms England said her son was perfectly healthy and had no mental health problems before taking the medication, recalling that he had been having trouble sleeping before his death.
“He had only been on that drug for a few days, literally just a few days,” England said. “It completely changed the trajectory of our lives.”
Reuters reports that Merck knew from early studies that the drug could affect the brain and claimed in a statement to regulators that it minimized the possibility of psychiatric problems. He also detailed the lawsuit that will be filed. Many of these lawsuits are still pending.
If you live in New York City and are struggling with suicidal thoughts or experiencing a mental health crisis, call 1-888-NYC-WELL for free and confidential crisis counseling. You can. If you live outside the five boroughs, dial the 24/7 National Suicide Prevention Hotline at 988 or visit the link below. SuicidePreventionLifeline.org.
