Nizoral Use For Skin, Nail Infections Linked To Liver Damage, Patient Death: FDA

Federal health regulators are warning that side effects of the antifungal medication Nizoral may cause serious liver damage and other health problems, indicating that doctors should stop prescribing the drug for skin and nail infections; a use for which it is not approved. 

The FDA issued a drug safety communication on May 19, indicating that off-label use of Nizoral for skin and nail fungal infections should be avoided. The agency says that the risk of problems from Nizoral outweigh the potential benefits for treating skin and nail infections.

In 2013, the FDA ordered warning label changes for Nizoral (ketoconazole) tablets, which removed approval for treatment of skin and nail infections and recommended that it only be used if alternative antifungal therapies are not available or cannot be tolerated by the patient.

The restrictions came following a benefit-risk assessment of the safety and effectiveness of the drug, during which reviewers determined that Nizoral side effects could increase the risk of liver damage cause adrenal gland problems that disrupt the balance of salt and water in a patient’s body, and can cause serious and life-threatening side effects when taken with certain other drugs.

“We approved label changes for oral ketoconazole tablets in 2013 to reflect these serious risks and to remove indications for treatment of skin and nail fungal infections,” the most recent FDA warning notes. “However, an FDA safety review found that oral ketoconazole continues to be prescribed for these types of conditions.”

The FDA found that over an 18-month period, ending June 2015, it appears that Nizoral was only prescribed for skin and nail infections, according to an office-based physician surveys database. That includes about 217,000 patients over a one-year period alone. In addition, one patient death from Nizoral-related liver damage was reported to the agency.

When drugs are prescribed for uses not approved by the FDA, it is called being prescribed off-label. While manufacturers are barred from promoting their drugs for off-label uses, doctors are allowed to prescribe medications for any reason they see fit. However, the FDA is urging doctors to stop prescribing Nizoral for skin and nail infections, and in fact urge them to only use Nizoral for any infection when no other antifungal therapies are available.

The agency is also suggesting patients discuss the risks and benefits of available therapies before they use any medication to treat skin and nail fungal infections. Patients taking Nizora should seek medical attention immediately if they show symptoms of liver problems, including:

• Loss of appetite
• Nausea
• Vomiting
• Abdominal discomfort
• Yellowing of the skin or whites of the eyes
• Unusually dark urine or light stools
• Pain and discomfort in the upper right abdomen

The agency notes that only Nizoral tablets are affected by the warning. There are topical forms of ketoconazole which have not been associated with the same health risks.