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.