Despite a warning from the Food and Drug Administration regarding “serious mental health” side effects, millions continue to use a frequently prescribed asthma medication.
In March 2020, the FDA issued a boxed warning about the mental health side effects of Singulair, a 25-year-old asthma and allergy drug also known by its generic name, montelukast, saying the risks of consuming this drug “may include suicidal thoughts or actions.”
But despite the warning, the New York Times reports that in 2022, 12 million individuals in the United States, including 1.6 million children, were still prescribed the drug, with some people still taking the drug today.
An FDA investigation from 1998 to 2018 linked the drug to 82 suicides, including 19 in children.
Warnings were first added in 2008, highlighting psychiatric risks on the label, with an additional warning in 2020. The FDA, in the added black box warning on the drug's label, states that the medication can lead to "serious neuropsychiatric events."
Nicole Sims, who spoke to the New York Times, said she had no clue why her 6-year-old son started having nightmares and hallucinations of a woman in the window. When he expressed a desire to die, she searched online for answers and found the FDA warning and a Facebook support group with over 20,000 members who had experienced side effects of the drug.
However, Dr. Reshma Ramachandran, an assistant professor at Yale University and a family doctor, told the New York Times that the warning hasn't effectively reached the channels doctors typically rely on. She stated that the FDA “needs to do much more in terms of direct communication to clinicians and through more active channels.”
Furthermore, a study in 2021 using Korean health data found that older adults with asthma who developed psychiatric problems were 70% more likely to have taken drugs like montelukast. In Denmark, a 2023 study showed that younger adults prescribed the drug were 38% more likely to subsequently require psychiatric or ADHD medications.
