Government researchers have found that a widely prescribed asthma medication The drug, originally sold by Merck & Co, may be linked to serious mental health problems for some patients, according to a scientific presentation reviewed by Reuters.
US researchers found that the drug, sold under the brand name Singulair and generically as montelukast, binds to several brain receptors important for psychiatric functioning.
Singulair was a blockbuster product for Merck when it was launched in 1998, providing relief in a pill as an alternative to inhalers. In early advertising, the company said that the side effects were so mild that they “like a sugar pillWhereas the label stated that any distribution to 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 episodes, including dozens of suicides, in patients prescribed the drug had accumulated on Internet forums and in the US Food and Drug Administration’s tracking system. Such “adverse event” reports do not prove a causal relationship between a drug and a side effect, but are used by the FDA to determine whether more study is needed about a drug’s risks.
After years of analysis, the report and new scientific research prompted the FDA in 2020 to add a “black box” warning to montelukast prescribing labels, flagging serious mental health risks such as suicidal thinking or actions.
The agency also convened a group of internal experts around the same time to explore why the drug might trigger neuropsychiatric side effects.
The results of the group’s work, which are preliminary and have not been previously reported or publicly released, were presented to a limited audience on Wednesday at the American College of Toxicology meeting in Austin, Texas.
The FDA said it has no plans to update the drug label based on the data from the presentation.
‘Something that is worrying’
Montelukast’s behavior appears to be similar to that of other drugs with neuropsychiatric effects, such as the antipsychotic risperidone, according to FDA slides reviewed by Reuters. The FDA cautions that its studies are ongoing, and the results have not been finalized.
When the FDA added the black box, it cited research by Julia Marschelinger and Ludwig Aigner at Austria’s Institute of Molecular Regenerative Medicine.
Both scientists told Reuters on Thursday that the new data showed that significant amounts of montelukast are present in the brain. He said the receptors involved play a role in regulating mood, impulse control, cognition and sleep, among other functions.
Both scientists said the research does not show whether that binding mechanism has direct harmful effects in individual patients, or who is particularly at risk. However, Marschallinger said the new data reinforces reports from people who reported suffering side effects.
“It’s definitely something that’s worrisome,” she said.
A representative for Merck did not respond to questions. Organon, a Merck spinoff that now markets Singulair, said in a statement that it is confident in the drug’s safety profile.
“Singulair’s product label contains appropriate information about Singulair’s benefits, risks, and reported adverse reactions,” the company said.
Reuters reported last year The FDA had received thousands of reports of patients, including many children, experiencing depression, suicidal thoughts and behavior, or other mental problems after starting to use montelukast.
As of 2019, the FDA counted 82 suicides linked to Singulair and its generic versions reported in its adverse-event database since 1998. At least 31 of these reports involved people 19 or younger.
Robert England’s 22-year-old son Nick committed suicide in 2017, less than two weeks after starting montelukast. England recalls that her son had trouble sleeping before he died, and says that he was completely healthy and had no mental health problems before taking the medication.
“He was on that drug for just a few days, literally just a few days,” England said. “It completely changed the direction of our lives.”
The Reuters report also details lawsuits alleging that Merck knew from its early research that the drug could have effects on the brain and downplayed the potential for psychiatric problems in statements to regulators. . Many of those cases are still pending.
If you are struggling with suicidal thoughts or experiencing a mental health crisis and live in New York City, you can call 1-888-NYC-WELL for free and confidential crisis counseling. If you live outside the five boroughs, you can dial the 24/7 National Suicide Prevention Hotline at 988 or visit SuicidePreventionLifeline.org,
