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May 19, 2016: One Patient Dies Due to Anti-Fungal Drug Nizoral Injury

Anti-Fungal Drug Nizoral Injury

FDA Warns Against Oral Tablet Form of Anti-Fungal Drug Nizoral

The U.S. Food and Drug Administration (FDA) issued a Safety Announcement on May 19, 2016, warning physicians and other health professionals to avoid prescribing the antifungal medicine ketoconazole oral tablets to treat skin and nail fungal infections. Ketoconazole is commonly know under the brand name Nizoral.

According to the FDA, Nizoral oral tablets have been associated with serious liver damage, adrenal gland problems, and harmful interactions with other medicines that outweigh its benefit in treating skin and nail fungal infections, which are not approved uses of the drug.

Background of Anti-Fungal Drug Nizoral Injury

ucm251847Nizoral is used to treat serious infections caused by fungi. Nizoral works by killing the fungus or preventing it from growing. The oral tablet form of this drug should only be used when other routes of treatment are not available or tolerated. The type of Nizoral which is applied to the skin or nails have not been associated with liver damage, adrenal problems, or drug interactions.

Anti-Fungal Drug Nizoral Injury Leads to Patient Death

In 2013, the FDA approved label changes for oral Nizoral tablets to reflect the risks of serious liver damage, adrenal gland problems, and harmful interactions with other medicines associated with the drug in its oral tablet form. The updated labeling also removed the indications for treatment of skin and nail fungal infections. However, an FDA safety review found that oral Nizoral continues to be prescribed for these types of conditions.

After an FDA study of the matter, it was discovered that during the 12-month period ending in June 2015, approximately 217,000 patients received dispensed prescriptions for oral Nizoral from U.S. outpatient retail pharmacies. One patient died due to liver failure associated with oral Nizoral prescribed to treat a fungal infection of the nails.


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