FDA Warns Oral Anti-Fungal May Cause Adrenal, Liver Problems

The Wall Street Journal (7/27, Burton, Subscription Publication, 2.29M) reported that the US Food and Drug Administration announced Friday that it was limiting the use of Johnson & Johnson’s oral, anti-fungal therapy, Nizoral (ketoconazole). Although the product is available as a topical, including as a cream and a shampoo, the agency said only the tablet form of Nizoral should not be used as a first-line treatment because of a potential risk for drug interactions, adrenal gland problems and fatal liver injury. The FDA also said it was revising the boxed warning on the treatment’s label to reflect this restriction, and posted a safety communication (pdf) on its website, detailing the issues that prompted the change. The Journal added that prior to the FDA’s announcement, J&J released a statement saying it had halted the US manufacture of Nizoral tablets.

In its coverage of the FDA warning, Bloomberg News (7/27, Nussbaum) noted that the European Medicines Agency’s Committee on Medicinal Products for Human Use also issued a statement Friday recommending that all “oral treatments containing ketoconazole” be suspended from the EU market. The CHMP said the “risk of liver damage, including hepatitis, outweighs the drug’s benefits.” Reuters (7/27, Dey) and MedPage Today (7/27, Gever) also covered the story.