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.