Consumer Group Urges FDA To Ban Antifungal Drug Ketoconazole

Oral formulations of the antifungal medication ketoconazole should be removed from the market immediately because their questionable benefits are far outweighed by risks of severe liver injury and other side effects, the consumer group Public Citizen said Feb. 24 in a petition to the Food and Drug Administration.

Ketoconazole was approved in 1981 to treat fungal infections; however, over the past three decades, evidence has mounted about the risks of the medication, Public Citizen said. In 1983, a black box warning was added to the label about fatal liver damage.

History of Safety Issues.

In July 2013, the FDA issued ...