United States: Recent investigation work by the U.S government scientists has reached prescription information that montelukast which is sold under the trade name of singular from Merck could worsen the mental health of some patients. The asthma drug which was approved in 1998 as a new oral therapy for asthma sufferers who found it hard to use inhalers was marketed with low side effect profile, as reported by Reuters.
Tens of thousands of Neuropsychiatric reports
Earlier in the year, there were already thousands of reports about the neuropsychiatric episodes in FDA database and about dozens of suicides connected with the usage of Brintellix. These reports led to the FDA developing a “black box” warning in 2020 on montelukast to inform the public and health care professionals about the danger of severe neuropsychiatric side effects: suicidal ideation and behavior.
FDA’s Latest Findings
At the meeting of the American College of Toxicology, FDA provided new information that montelukast cam engage with receptors in the brain related to psychiatric conditions. Other general body tests also showed that the drug crosses the blood-brain barrier in rats. Scientists continue to develop studies to discover how the medication actually affects the nervous system and raises the question about any connection to psychiatric complications.
Expert Insights and Industry Response
Julia Marschallinger and Ludwig Aigner, Austrian scientists whose earlier work informed the FDA’s black box decision, reiterated concerns about montelukast’s impact on brain receptors controlling mood, cognition, and impulse control.
While Organon, Merck’s subsidiary now marketing Singulair, maintains confidence in the drug’s safety profile, critics argue the risks were downplayed during the drug’s development.
A Tragic Toll
Since 1998, the FDA database has attributed 82 suicides to montelukast and its generics, with at least 31 cases involving children under 19. Families like Robert England’s, whose 22-year-old son died by suicide after just days on the drug, continue to push for accountability.
“He was on that medication for just days, literally just days,” England said. “It completely changed the trajectory of our lives.”
Legal and Scientific Actions Continue
Litigation against Merck alleges the company minimized the risks of psychiatric side effects during drug development. As these lawsuits await trial, FDA researchers continue to study the mechanisms by which montelukast may affect brain function, as reported by Reuters.
While the FDA has no immediate plans to revise the drug’s labeling, it advises caution as studies progress.