FDA Denies Public Citizen Petition to Pull Oral Ketoconazole

The FDA denied a petition from Public Citizen to remove the antifungal medication oral ketoconazole from the market.

In its petition, submitted in February 2015, the advocacy group argued that the fatal liver failure risks and hazardous drug interactions outweighed the drug’s antifungal benefits.  In its response, the agency disagreed with the petition’s claim that there are no patients for whom benefits outweigh risk.

Public Citizen based its conclusions largely on a 2013 assessment by the FDA’s Office of Surveillance and Epidemiology. But since then, the agency has conducted further research, including analysis of drug use data for ketoconazole, and concluded it should stay on the market with its current narrow indications. Removing the drug from the market, the agency states, would leave endemic mycoses patients who are intolerant to alternative fungal medications with no oral therapy option.