The Food and Drug Administration (FDA) presented the preliminary results of new research on montelukast at the American College of Toxicology meeting recently, describing potential side-effect risks for the oral asthma drug. Montelukast may be leading to mental health conditions and suicide by attaching to multiple brain receptors that are involved in psychiatric functioning, researchers say. According to Reuters, thousands of patients have reported neuropsychiatric episodes, prompting the FDA to launch a comprehensive investigation and to place a black box warning on the montelukast label in 2020. Even with this recent study, the agency says it does not have immediate plans to issue a new update to the montelukast label because research is still ongoing.Â
Common condition and common treatment: According to the most recent data from 2021, almost 25 million Americans have asthma, including 4.6 million children. More than 986,000 emergency department visits are attributed to asthma attacks in the United States. About 30 million prescriptions for montelukast were written annually in each of the past several years.