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The U.S. Food and Drug Administration (FDA) has issued a Drug Safety Communication to warn about severe, life-threatening side effects of oral Nizoral (ketoconazole), a powerful drug used to treat fungal infections. The FDA is concerned about the risk of liver injury, drug interactions, and adrenal gland problems.

What is Nizoral?

Nizoral (ketoconazole) is a broad-spectrum oral medication for treating fungal infections. Nizoral works by blocking an enzyme that is a key component of the fungal cell membrane. This weakens the structure of the cell and destroys the fungus. It comes in oral tablets and topical formulations (shampoos, creams, etc.). Only the oral forms of Nizoral have been restricted.

FDA Adds Black Box Warning to Nizoral Prescribing Information

In July 2013, the FDA updated the Prescribing Information for oral Nizoral to include the following Black Box Warning:

“Nizoral tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks.”

Nizoral Suspended by European Medicines Agency

The European Medicines Agency (EMA) and the Committee for Medicinal Products for Human Use (CHMP) have issued a statement to announce that they are recommending suspending Nizoral throughout the European Union (EU):

“Doctors should no longer prescribe oral ketoconazole and should review patients’ treatment options. … Taking into account the increased rate of liver injury and the availability of alternative antifungal treatments, the CHMP concluded that the benefits did not outweigh the risks.”

The EMA warned about the following problems with Nizoral:

  • “The incidence and the seriousness of liver injury with oral Nizoral were higher than with other anti-fungals.”
  • “Reports of liver injury occurred early after starting treatment with recommended doses, and it was not possible to identify measures to adequately reduce this risk.”
  • “The clinical benefit of oral Nizoral is uncertain as data on its effectiveness are limited and do not meet current standards.

Nizoral and Liver Injury (Hepatoxicity)

All anti-fungal medications can cause liver injury (hepatoxicity). Unfortunately, Nizoral has been linked to more frequent and more serious cases of liver injury than other anti-fungal medications, according to a study published in British Journal of Clinical Pharmacology in 1999.

FDA Black Box Warning for Nizoral and liver injury:

“Serious hepatoxicity, including cases with a fatal outcome or requiring liver transplantation has occurred with the use of oral ketoconazole. Some patients had no obvious risk factors for liver disease.”

In general, the onset of liver injury occurs between 1 and 6 months after starting Nizoral, but it has been reported as early as 1 month after starting treatment at the recommended dose of 200-mg.

Reported cases of liver injury associated with Nizoral include:

  • Hepatoxicity
  • Hepatitis
  • Cirrhosis of the liver
  • Liver failure
  • Liver transplantation
  • Death

Nizoral and Adrenal Gland Problems (Adrenal Insufficiency)

Nizoral can decrease the body’s production of hormones called corticosteroids, which may cause adrenal insufficiency. The adrenal gland is located on top of each kidney. They are responsible for balancing water, salt, and minerals (electrolytes) in the blood. These hormones also help maintain blood pressure, cardiovascular functions, and metabolism.

Complications of adrenal insufficiency include:

  • Fatigue
  • Weakness
  • Nausea, vomiting
  • Diarrhea
  • Loss of appetite
  • Weight loss
  • And more

Nizoral and Drug Interactions

Nizoral can interact with other drugs and result in life-threatening complications, including abnormal heart rhythm. Combining Nizoral with contraindicated medications (dofetilide, quinidine, pimozide, and cisapride) can increase the concentration of these medications in a patient’s bloodstream. In some cases, this can interfere with electrical activity in the heart and cause the following complications:

  • Abnormal heart rhythm
  • Cardiac arrhythmia
  • QT interval prolongation
  • Torsades des pointes
  • Ventricular dysrhythmia
  • Death