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 the FDA's Jessica Oliphant, these are "significant bindings," with the highest concentrations of the drug found in areas of the brain involved in psychological functions.

Who is most at risk?

Although researchers have not confirmed a direct causal link between the use of the drug and its effects on the psyche, they point out that some cases are alarming. For example, Robert England, whose son committed suicide shortly after being put on montelukast, described how quickly the healthy young man began to behave unusually.

According to FDA statistics, 82 suicides associated with montelukast use have been reported from 1998 to 2019, including at least 31 in children and adolescents under the age of 19. These cases raise questions about the safety of the drug, especially for young patients.

Reactions from pharmaceutical companies

Neither Merck, the original manufacturer of Singulair, nor its offshoot Organon, which now distributes the drug, has yet admitted to any major wrongdoing. Organon has said that the drug's label contains adequate information about its risks and benefits. Meanwhile, however, lawsuits are pending against Merck, which claims that the company knew from initial research about the drug's potential effects on the psyche, but minimized that information.

Disclaimer: You will find a lot of inspiration on Bulios, but stock selection and portfolio construction is up to you, so always do a thorough analysis of your own.

Source: Investing.com, Reuters.