In the News

Public Citizen Calls for Ketoconazole (Nizoral) Recall

By June 9, 2015 October 14th, 2019 No Comments

The consumer advocacy group Public Citizen is well known for working to alert the public to products which could prove dangerous, and they recently sent a petition to the FDA calling for the recall of all products containing ketoconazole

Ketoconazole was first sold under the brand name Nizoral, and has been used to treat fungal infections since 1981. In 2013, the FDA stated that Nizoral should not be the first line of treatment for fungal infections, but should only be used when other therapies are not tolerated by the patient or prove ineffective. On the same day as the FDA drug safety communication was issued, European regulators called for a recall of Nizoral. These actions led to the cessation of production of Nizoral brand tablets, but ketoconazole was still sold as a generic product.

Ketoconazole has been linked by multiple studies and adverse event reports to serious health threats including adrenal insufficiency and even liver failure.

According to the petition Public Citizen sent to the FDA, “In 2012, approximately 5.2 million ketoconazole prescriptions were dispensed, of which 609,000 (12 percent) were for tablet formulations, with nonsystemic fungal infections treated in outpatient clinics representing the most common use.”

Though a Nizoral recall was never issued, Public Citizen looked into the studies the FDA conducted to verify the safety of the drug. They found that the agency had received 42 reports of liver toxicity linked to ketoconazole between 1980 and 2011. 90% of the patients were hospitalized, 25% of them required liver transplants, and up to one-half of the patients died.

Public Citizen underscored the severity of liver failure in its petition to the FDA, and stated that, though other antifungal medications may also cause liver damage, the risk is highest by far with ketoconazole.

If you believe that you or someone you love suffered liver damage or even death due to an antifungal medication like Nizoral, you could be entitled to compensation. For more information on dangerous drug lawsuits, contact an experienced personal injury lawyer.

Leave a Reply