News Brief for July 2015

Public Citizen Petitions FDA for Removal of Oral Anti-Fungal Drug

In February, Public Citizen petitioned the Food and Drug Administration (FDA) to remove all oral forms of the anti-fungal drug ketoconazole from the U.S. market because the drug’s risks far outweigh its questionable benefits in treating fungal infections. Non-oral forms of ketoconazole, such as creams, do not pose the same risks.[1]

Oral ketoconazole, approved in 1981 to treat fungal infections, is associated with fatal liver injury, adrenal gland disorders and multiple medication interactions. In July 2013, the FDA issued a safety communication restricting the approved uses of oral ketoconazole, but Public Citizen obtained an unreleased internal agency memo revealing a previous recommendation from the FDA’s Office of Surveillance and Epidemiology that the agency remove the drug from the market. The team noted that, for all of oral ketoconazole’s FDA-approved uses, multiple treatments exist that are safer and equally or more effective. To read the petition, visit www.citizen.org/hrg2241.

References
[1] Public Citizen. Petition to the FDA to Ban All Oral Forms of the Anti-Fungal Drug Ketoconazole. February 24, 2015. http://www.citizen.org/hrg2241. Accessed April 21, 2015.