Singulair's Black Box Warning: What's the Real Risk?

Montelukast (Singulair) was a seemingly safe, widely prescribed asthma drug for over two decades — until the FDA issued a boxed warning in 2020 for serious neuropsychiatric events. But what does the absolute risk actually look like? This episode breaks down the numbers behind the headlines, examining large observational studies that put the risk at roughly four additional cases per thousand patients. We explore who might be most vulnerable, what a practical monitoring protocol looks like, and why the drug remains a valuable option despite the warning. Plus: how montelukast works, its unique benefits for certain conditions like aspirin-exacerbated respiratory disease, and what alternatives exist for patients who want to avoid it.