AB Desk, New Delhi, 23-11-24: U.S. government researchers have discovered that montelukast, a widely prescribed asthma medication sold under the brand name Singulair, may be linked to serious mental health issues. According to a presentation reviewed by Reuters, the drug binds to brain receptors crucial for psychiatric functioning, raising concerns about its potential neuropsychiatric side effects.
A Once-Promising Solution
Montelukast was introduced in 1998 by Merck & Co as a convenient pill alternative to inhalers. Initially, the drug was touted as having side effects comparable to a “sugar pill,” with minimal distribution in the brain. However, generic versions of the drug are still prescribed to millions of adults and children annually, despite accumulating evidence of its risks.
The Emergence of Warnings
By 2019, thousands of reports of neuropsychiatric episodes, including depression, suicidal thoughts, and suicides, began to emerge in patient forums and the U.S. Food and Drug Administration (FDA) database. While such reports do not establish a definitive causal link, they prompted extensive FDA analysis.
In 2020, the FDA added a “black box” warning to montelukast’s label, flagging its potential to cause serious mental health issues, including suicidal thoughts and actions. Around the same time, FDA experts began investigating the underlying mechanisms that might explain these effects.
New Research Findings
Recent findings at the American College of Toxicology meeting indicate that montelukast binds to multiple brain receptors, including those involved in mood, cognition, impulse control, and sleep. The FDA’s deputy director, Jessica Oliphant, stated that the drug penetrates brain regions associated with psychiatric effects. However, further research is required to understand how the drug accumulates in the nervous system and its long-term impacts.
The FDA slides also compared montelukast’s behavior to drugs like risperidone, known for neuropsychiatric effects. While these findings are preliminary, they echo concerns raised by earlier scientific research.
Personal Tragedies and Legal Implications
The risks of montelukast have had devastating consequences for some families. Robert England, for example, lost his 22-year-old son Nick to suicide less than two weeks after Nick began taking the drug. England described the drastic behavioural changes Nick experienced, saying, “It completely changed the trajectory of our lives.”
Such cases have fueled lawsuits alleging that Merck minimized the risks of psychiatric side effects in early regulatory communications. Many of these lawsuits remain unresolved.
Pharmaceutical Companies Respond
Organon, a Merck spinoff now marketing Singulair, has defended the drug’s safety profile, stating that its product label appropriately warns about risks and side effects. However, the lack of response from Merck regarding recent findings has added to public concern.
Looking Forward
While montelukast remains a commonly used medication for asthma and allergies, the ongoing research into its effects highlights the need for caution. As regulators and researchers work to clarify the risks, patients and healthcare providers must weigh the benefits of montelukast against its potential mental health impacts.
This evolving story serves as a reminder of the importance of vigilance in monitoring drug safety, especially for medications prescribed to vulnerable populations such as children.
Source: Reuters
