- Ketoconazole pills, used for hard-to-treat fungal infections, carry a label warning of potentially fatal liver danger.
- Ketoconazole pills, which are generics made by Teva and Mylan, were approved in 1981 and came with the black-box warning.
- In 2013, the FDA voted to restrict ketoconazole's use to infections that don't respond to other treatments.
At issue here is not topical ketoconazole, which is used to treat athlete's foot and similar conditions. However, according to Public Citizen, a consumer watchdog group, 14 scientists from the FDA's surveillance unit have concluded that the risks of ketoconazole outweigh the benefits.
In fact, these findings led to the FDA restriction in January 2013. Despite that. Public Citizen has noted that 462,000 prescriptions for ketoconazole were filled in 2014. In contrast, European regulators have completely banned oral ketoconazole. The result, according to Public Citizen, is hundreds of fewer cases of ketoconazole-related liver toxicity—a situation that they would like to replicate in the U.S.