J&J Anti-Fungal Tablet Draws FDA Liver-Damage Warnings

Johnson & Johnson (JNJ)’s anti-fungal Nizoral tablets raise the risk of deadly liver injuries and harmful drug interactions and their use should be limited, regulators in the U.S. and European Union said.

The U.S. Food and Drug Administration said in a statement today that it changed the drug’s label to warn that Nizoral tablets shouldn’t be the first line of treatment for a fungal infection. The European Medicines Agency, meanwhile, said it was recommending a suspension of marketing for oral treatments containing ketoconazole, Nizoral’s main ingredient.

The risk of liver damage, including hepatitis, outweighs the drug’s benefits, the EU agency said, while the FDA said the medication can cause adrenal-gland problems as well as liver injuries that may be fatal or require a transplant. New Brunswick, New Jersey-based J&J, the world’s biggest maker of health-care products, hasn’t released sales figures for the tablet in recent financial statements.

Nizoral also comes in topical formulations, including creams, shampoos, foams, and gels applied to the skin, the FDA said. None of those have been associated with liver damage, adrenal problems, or drug interactions, the FDA said.

J&J rose less than 1 percent to $92.83 at the close in New York. The shares have gained 32 percent this year.

To contact the reporter on this story: Alex Nussbaum in New York at anussbaum1@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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