Risky Drugs Revealed: The Untold Story of Black Box Warnings

As of November 2025, the FDA's most serious drug safety alerts, known as black box warnings, have been applied to over 400 medications. These warnings are designed to alert healthcare providers to the potential for serious adverse events or even death associated with certain drugs.

The use of black box warnings dates back to the 1960s, when a consumer protection law required pharmaceutical companies to provide detailed information about their products. Over the years, the FDA has issued these high-level warnings for a range of drugs, from antidepressants to hormone replacement therapies.

While black box warnings are intended to promote patient safety, they can also significantly influence how clinicians prescribe certain medications. For example, the warning on the schizophrenia drug clozapine has led many doctors to reserve it as a last resort due to the risk of life-threatening infections.

However, the landscape of black box warnings is evolving. In November 2025, the FDA removed the warning for hormone replacement therapy, citing new data that showed the therapy does not pose significant risks for women aged 50 to 60. This decision reflects the FDA's ongoing efforts to balance drug safety with patient access and clinical needs.

As the use of black box warnings continues to be a critical tool in the FDA's arsenal, healthcare professionals and patients alike must stay informed about the latest developments and their implications for medication management.