Petition to the FDA to Ban All Oral Forms of the Anti-Fungal Drug Ketoconazole

View as PDF.

View OSE reviewers’ Memo.

View the Press Release.

Public Citizen petitions the Food and Drug Administration (FDA) to immediately require that the oral forms of the antifungal agent ketoconazole be removed from the market because the drug’s risks of fatal liver failure and adrenal insufficiency, and its numerous drug interactions, outweigh its limited benefits in treating fungal infections.

February 24, 2015, Acknowledgement letter from the FDA.

December 23, 2015, Interim response from the FDA.

September 1, 2017, Final response from the FDA.