Nizoral Liver Damage Risks Lead to “Do Not Use” Recommendation

The prominent consumer watchdog group Public Citizen is warning against the use of the oral tablet version of Nizoral, an antifungal treatment, due to the serious liver injury risk.  

In the latest edition of Public Citizen’s Worst Pills, Best Pills (subscription required), Nizoral (ketoconazole) tablets were placed on the groups “do not use” list.

The recommendation comes after the FDA restricted use of the drug this summer and European drug regulators called for Nizoral to be recalled from the market due to the risk of liver damage.

“Liver injury caused by ketoconazole tablets has been estimated to occur in 1 of 500 patients with no prior history of liver disease,” warns Public Citizen in the report. “Liver damage can be severe, leading to liver transplant or death in some patients, including in those without a prior history of liver disease. Although other antifungal medications in the same class also can cause liver damage, the risk is considerably higher with ketoconazole.”

The group warned that Nizoral side effects can also cause adrenal gland problems, disrupting the body’s balance of water, salts and minerals, and can also react with a large number of other drugs and cause fatal heart rhythm problems.

In July, the FDA issued a drug safety communication warning of Nizoral liver problems, adding new label warnings, updated the medication guide to the drug, and warned doctors to only use it as a last result if other antifungal therapies are not available or are not tolerated by the patient. However, the FDA let the drug stay on the market, saying that it still had uses.

The European Medicines Agency went one step further, calling for Nizoral to be removed from the market after determining that the liver risks outweigh the benefits.

Johnson & Johnson, the manufacturer, suspended production before the FDA warning, but has not issued a Nizoral recall.

Public Citizen states that it agrees with the EMA recommendations that remaining Nizoral tablets be removed from pharmacy and hospital inventories completely. However, the group notes that patients should not stop taking any prescribed drug without first consulting their physician.

“Do not use ketoconazole tablets under any circumstances,” the group warns. “If you are currently taking ketoconazole, see your doctor immediately to consider switching to another therapy.”