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Popular asthma medication Singulair, also known by its generic name, montelukast, was prescribed to 12 million Americans in 2022, including 1.6 million children. Yet the Food and Drug Administration was slow to alert the public to decades of escalating concerns that the drug could cause aggression, despair and suicidal thoughts, especially in young children, according to a new report in The New York Times. After over twenty years, the FDA finally issued a warning label on the drug in 2020, but the move failed to register with many patients or caregivers. After initially dismissing evidence of adverse effects on the brain during the drug’s approval process in 1998, the FDA discovered nearly a decade ago that the drug’s manufacturer, Merck, had received thousands of reports of side effects. After a high-profile suicide of a teenage patient in 2007, the FDA still would not force Merck to conduct more rigorous and expensive studies that could have uncovered how common adverse reactions were.
Asthma can be deadly, and the drug is prescribed to children as young as three. Researchers who reviewed side effect reports collected by the World Health Organization in 2015 found outsized rates of anxiety and suicidal behavior among children on montelukast, which researchers deemed “striking” in young children. The year before, Merck unsuccessfully sought approval to sell Singulair over the counter, and FDA records from an oversight meeting that year showed that the company had data on about 46,500 cases of adverse effects. WHO officials only knew about less than one-third of those events. As of 2019, the FDA had documented 82 suicides of people on montelukast, and more than 500 suicide attempts have been linked to the drug through unverified reports to the federal agency. In a 2023 court filing, Merck still denied “a significant link between Singulair and neuropsychiatric events.”
Merck spun the drug off to a company called Organon in 2021, and referred comments from Times reporters to that company. Organon told the paper in a statement that it had communicated appropriate information to patients and health providers about the drug’s risks and benefits. “Nothing is more important to Organon than the safety of our medicines and the people who use them,” the company said. Yes, absolutely. If we’ve learned anything from the past half-century, it’s that major pharmaceutical companies would never lead us astray.
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