A study funded by the U.S. government has discovered that a popular asthma drug called Singulair, with the chemical name montelukast, could be linked to severe mental problems in some patients. Researchers uncovered that the medication binds to brain receptors vital for mood regulation, cognition, and impulse control.
The research was discussed at a recent toxicology meeting in Austin, Texas, though it is still not published. The FDA investigation comes in the wake of several years of reports of drug-related neuropsychiatric side effects, such as suicidal thoughts and actions.
Since the inception of montelukast in 1998, this medication has been popular for asthma management, initially targeted as safe and effective. However, escalating concerns over psychiatric effects prompted the FDA in the year 2020 to add a “black box” the agency’s strongest caution that depicts risks associated with depression and even suicidal tendencies.
This new research further supports these concerns, as the drug crosses into regions of the brain associated with psychiatric effects. Despite this, the FDA has said it won’t alter the label any further at this time.
Asthma drug Montelukast has even caused suicides
Montelukast has been linked to at least 82 suicides reported to the FDA since its debut, with 31 involving individuals aged 19 or younger. Families affected by these tragedies, like Robert England, whose 22-year-old son Nick died by suicide just days after starting the medication, are demanding accountability. “It completely changed the trajectory of our lives,” England said.
Organon, the new marketer of Singulair, continues to hold its product safe. Detractors, however, said that Merck, the original developer of Singulair, underplayed risk possibilities early on. Lawsuits charging Merck with negligence continue.
More research needs to be conducted, experts say, on montelukast’s impact on the nervous system. The findings by the FDA are preliminary in nature but indicate a call to monitor the taking of the medication warily, more so with children and adolescents.
The new revelations about montelukast do serve as an effective reminder of the fine balance between the treatment benefits and possible side effects, especially in matters of psychiatric health.
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