Popular asthma drug linked to serious psychological problems

The drug montelukast, known by its brand name Singulair, was considered a revolution in asthma treatment when it was introduced in 1998. It offered an easy alternative to inhalers and was promoted as safe with minimal side effects. However, new scientific findings and thousands of reports of serious mental health problems, including suicides, have cast doubt on its safety.

Montelukast and its original promise

Findings from the FDA and scientists

After analyzing thousands of reports, the U.S. Food and Drug Administration (FDA) added a "black box" warning, the highest level of warning about the drug's potential risks, to montelukast in 2020. This warning highlights possible serious psychological side effects such as depression, suicidal thoughts and actions.

At a scientific conference in Austin, Texas, FDA researchers presented the new lab test results. These showed that montelukast binds to receptors in the brain that regulate mood, impulsivity, sleep and cognitive function. According to…