Nizoral Liver Problems Result in FDA Warning

Side effects of the antifungal treatment Nizoral may cause deadly liver injury, adrenal gland problems and may interact dangerously with other medications, according to a warning issued by federal drug regulators.

In a drug safety communication (PDF) issued by the FDA on July 26, the agency indicated that Nizoral should only be used as a drug of last resort for treatment of certain fungal infections.

The FDA has approved label changes for Nizoral that recommend the Johnson & Johnson drug only be used if alternative antifungal therapies are not available or cannot be tolerated by the patient.

Johnson & Johnson officials have indicated that the manufacture of Nizoral (ketoconazole) tablets was suspended before the FDA’s drug safety communication.

The restrictions come in the wake of a comprehensive FDA benefit-risk assessment on the safety and effectiveness of the drug. Reviewers found that Nizoral side effects may increase the risk of liver injury, which could result in death or the need of a liver transplant. They also found that Nizoral can decrease the production of corticosteroids, causing adrenal gland problems that disrupt the balance of water and salt in a patient’s body. The drug was also found to produce serious and life-threatening side effects when taken with certain other drugs, including heart problems.

The label warnings will be updated to contraindicate the use of Nizoral by patients with liver disease and FDA approval has been restricted to the treatment of blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis fungal infections. Even then, it is only to be used in patients who cannot be treated with another antifungal therapy.

In 2012 there were about 5.2 million ketoconazole prescriptions given out, but only about 609,000, or 12%, were in the tablet formation affected by the new restrictions and warnings.

The FDA advises patients to be aware of Nizoral health risks and contact a health care professional immediately if they are taking Nizoral and start to show signs of liver problems, including:

• Loss of appetite, nausea, vomiting or other abdominal problems
• Fever and fatigue
• Signs of jaundice, including yellowing of the skin or the whites of the eyes
• Unusually dark urine or lightly colored stool
• Pain and discomfort in the liver (the upper right abdomen)

The FDA also recommends patients discuss any other medications they are taking with their doctor before taking Nizoral, due to the risk of drug interactions. The agency also recommends not using alcohol, drugs or medications that include acetaminophen, due to increased risk of liver injury.