FDA Limits Use of Nizoral Antifungal Tablets Due to Risks for Liver Injury

The Food and Drug Administration (FDA) has issued a safety notice saying that the fungal pill Nizoral (ketoconazole) can cause severe liver injuries and adrenal gland problems and shouldn’t be used as a first-line treatment.

The FDA is taking several actions related to Nizoral  oral tablets, including limiting the drug’s use, warning that it can cause severe liver injuries and adrenal gland problems and advising that it can lead to harmful drug interactions with other medications.  The FDA has approved label changes and added a new Medication Guide to address these safety issues.  As a result, he FDA states that Nizoral oral tablets should not be a first-line treatment for any fungal infection.   Instead, Nizoral should be used for the treatment of certain fungal infections, known as endemic mycoses, only when alternative antifungal therapies are not available or tolerated.

The topical formulations of Nizoral have not been associated with liver damage, adrenal problems, or drug interactions. These formulations include creams, shampoos, foams, and gels applied to the skin, unlike the Nizoral tablets, which are taken by mouth.

According to the WS Journal (7/26/13 Burton), Johnson & Johnson, the maker of Nizoral, said the manufacture of the tablets for the U.S. market had been suspended before the FDA announcement. It said a European Medicines Authority committee has recommended against continued sale in Europe, but that the company continues to sell the tablets in some other countries.

The FDA said that topical forms of the medicine, such as ointments, creams, shampoos and gels, haven’t been linked to the liver damage and adrenal problems.

If you have been injured by Nizoral or another medical drug or device, contact our pharmaceutical drug and device lawyers by calling toll-free 888-841-9623.

Zoll, Kranz & Borgess, LLC – Mass Tort and Class Action Lawyers

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