3 hours Ago By Debosmita Ghosh
A new study found that a widely prescribed asthma drug may be linked to severe mental health issues and suicide for some patients. The Food and Drug Administration (FDA) presented the preliminary results of a study on the asthma drug Singulair which is which is sold generically as montelukast, to a “limited audience”. The scientific presentation was reviewed by Reuters.
The study found that the drug attaches to multiple brain receptors critical to psychiatric functioning. According to a report in Reuters, Singulair was a blockbuster product after its launch in 1998. It offered relief in a pill as an alternative to an inhaler.
In early advertising, the company said the side effects were so benign that they were “similar to a sugar pill,” while the label said any distribution in the brain was “minimal.” Generic versions are still prescribed to millions of adults and children every year. However, by 2019, thousands of reports of neuropsychiatric episodes, including dozens of suicides, in patients prescribed the drug had piled up on internet forums and in the U.
S. Food and Drug Administration’s tracking system. These “adverse event” reports do not prove a causal link between a medicine and a side effect but are used by the FDA to determine whether more studies of a drug’s risks are warranted.
After analysis, the reports and new scientific research led the FDA in 2020 to add a “black box” warning to the montelukast prescribing label, flagging serious mental health risks like suicidal thinking or actions. The agency also convened a group of internal experts around the same time to look into why the drug might trigger neuropsychiatric side effects. The results of the group’s work were presented to a limited audience at the American College of Toxicology meeting in Austin, Texas.
Jessica Oliphant, a deputy director at FDA’s National Center for Toxicological Research, said at the event that laboratory tests showed “significant binding” of montelukast to multiple receptors found in the brain. The FDA also said that scientific research shows montelukast penetrates the brains of rats. Oliphant said that more studies are needed about how the drug accumulates in the nervous system.
She added, “These data indicate that montelukast is highest in brain regions known to be involved in (psychiatric effects).” When the FDA added the black box, it cited research from Julia Marschallinger and Ludwig Aigner at Austria’s Institute of Molecular Regenerative Medicine. Speaking to Reuters, the two scientists said that the new data showed significant quantities of montelukast present in the brain.
They said that the receptors involved play a role in governing mood, impulse control, cognition and sleep, among other functions. The research does not show whether that binding mechanism leads directly to harmful effects in individual patients or who is particularly at risk, the two scientists said. However, Marschallinger said the new data bolsters reports from people who reported suffering side effects.
She added, “It’s definitely doing something that’s concerning.” (With inputs from Reuters) Get Latest News Live on Times Now along with Breaking News and Top Headlines from Health and around the world..
