Side Effects of Singulair May Increase Risk of Mental Health Problems in Some Patients: Report

Federal researchers have discovered that side effects of Singulair may actually be responsible for causing a number of reported suicide attempts and suicidal thoughts  experienced by users of the popular asthma drug, according to a Reuters report.

Singulair and its generic equivalent montelukast are popular asthma medications first approved for use in 1998. Unlike previous asthma drugs that are usually taken via inhaler, Singulair and montelukast work as a daily pill, which can prevent serious asthma symptoms that are often immune to other treatments.

However, by 2019, the U.S. Food and Drug Administration (FDA) found that there were thousands of reports of neuropsychiatric episodes related to the drug, including at least 82 suicides, 31 of which involved a person 19-years-old or younger.

Although these reports do not prove a definitive link between the medication and its potential side effects, the FDA determined a closer examination of Singulair’s risks was warranted.

In 2020, the FDA determined that a “Black Box” label warning about risk of suicide on Singular was necessary. In addition, FDA experts began further research to explore how the drug might cause the alleged side effects.

According to a report published by Reuters News, the results of this study were quietly presented at the American College of Toxicology meeting in Austin, Texas last month, to a limited audience.

Reuters indicates that the FDA experts discovered montelukast and Singulair can penetrate the brains of rats, and the drugs appear to bond with multiple brain receptors, particularly ones associated with psychiatric effects, such as suicidal ideation and impulse control.

However, the FDA indicates that these results have not been finalized and the study is ongoing. The agency does not currently intend to update any warning labels for the drugs, Reuters says in its report.

“The product label for Singulair contains appropriate information regarding Singulair benefits, risks and reported adverse reactions,” Organon, the spinoff company from drug manufacturer Merck that now markets Singulair, told Reuters in a statement.

Singulair Mental Health Concerns Lead to Calls for Stricter Labels

Although a number of Singulair lawsuits have been filed In the U.S. over the medication’s suicide risks, regulators fear that many parents, caretakers and patients still appear to be unaware of the danger presented by Singulair.

Earlier this year, New York Attorney General Letitia James sent a letter to the FDA asking for changes to be made to Singulair’s warning label, due to the medication’s pediatric suicide risks.

In her letter, James stated that Singulair’s mental health side effects make it a safety risk, and more than just a black box label is needed to protect American children.

U.K. regulators have already taken action, with a Singulair label update announced by the Medicines and Healthcare Products Regulatory Agency (MHRA) in April, which added more prominent warnings about the risk of sleep disorders, aggression and depression to the prescription guide, including a black box warning.