Tonton Dfm2u
U.S. government investigators have found that an asthma drug previously sold by Merck & Co may be linked to serious mental health problems in some patients, according to a scientific report reviewed by Reuters.
Researchers found that the drug, sold under the brand names Singulair and montelukast, binds to several brain receptors important for mental function. Singulair has been a successful product for Merck since its launch in 1998, offering relief in pill form as an alternative to hot flashes.
In its initial advertising, the company said its side effects were so mild that they were “similar to those of diabetes medications,” while the label said any spread to the brain was “minor.” Millions of adults and children are still registered every year.
But by 2019, thousands of reports of neuropsychiatric disorders, including many suicides, in patients given the drug had been collected on Internet forums and in the US Food and Drug Administration system. These “adverse event” reports do not prove a cause-and-effect relationship between the drug and the side effects, but the FDA uses them to determine whether further investigation of the drug’s risks is necessary.
After years of research, new reports and scientific research led the FDA in 2020 to add a “black box” warning to the prescription label for montelukast, warning of serious mental health risks such as suicidal thoughts or behavior. The agency also convened a group of internal medicine experts at the same time to study why the drug may trigger adverse neuropsychiatric effects.
The results of the group’s work, which has not been previously reported or made public, were presented to a small audience at the American College of Toxicology meeting in Austin, Texas, on Wednesday. Jessica Oliphant, deputy director of the FDA’s National Center for Toxicology Research, said the study and laboratory tests showed “significant binding” of montelukast to multiple receptors in the brain.
The FDA has supported previous scientific research showing that montelukast penetrates the brains of rats. Further studies are needed to determine how the drug interacts with the nervous system, Oliphant said.
“These data suggest that montelukast is highly concentrated in brain regions known to be involved in (emotional) function,” he said. The FDA said it does not plan to update the drug’s labeling based on the data from the filing.
“Concerns”
Montelukast’s actions are similar to those of other drugs known to have neuropsychiatric effects, such as the antipsychotic risperidone, according to an FDA filing reviewed by Reuters. The FDA cautioned that its study is ongoing and has not yet produced any conclusive results.
When the FDA added the black box, it cited research by Julia Marschallinger and Ludwig Aigner of the Austrian Institute for Biologically Active Substances. The two scientists told Reuters yesterday that the new data showed a significant concentration of montelukast in the brain.
The receptors were involved in mood regulation, impulse control, cognition and sleep, among other functions, they said. The study doesn’t show whether this combination of mechanisms directly leads to harmful effects in individual patients, or in those at risk, the two scientists said.
However, Marschallinger said the new data supports reports from people who have reported experiencing side effects. He said: “It is clear that he is doing something that is disturbing.
A Merck representative did not respond to questions. Organon, the Merck subsidiary that currently markets Singulair, said in a statement that it is confident in the drug’s safety profile.
“The product information for Singulair contains appropriate information about the benefits, risks, and adverse reactions of Singulair,” the company said. Last year, Reuters reported that the FDA had received thousands of reports of patients, many of them children, experiencing depression, suicidal thoughts and behavior or other mental health problems after starting montelukast.
In 2019, the FDA identified 82 suicides linked to Singulair and all its variants reported to its adverse reaction database since 1998. At least 31 of the reports involved people aged 19 or older.
Robert England’s 22-year-old son Nick committed suicide in 2017, less than two weeks after starting montelukast. England recalled that her son had trouble sleeping before he died, and said he was in perfect health and had no mental health issues before taking the medication.
“He was on this medication for a few days, literally a few days,” England said. It has completely changed our way of life. »
The Reuters report also reported on the lawsuit alleging that Merck knew from its early research that the drug could affect the brain and reduce the risk of mental disorders in its claims.
