First the U.S. Food and Drug Administration limited a certain antifungal drug’s use, and now an advocacy group has called for its removal in oral form from the market. The drug is ketoconazole, which is sold under the brand name Nizoral. The drug, which has been made and marketed by Janssen Pharmaceuticals, has been linked to liver and adrenal injuries.
The organization Public Citizen wants the FDA to take the action that it stopped short of taking in 2013 – remove the tablets from the market immediately because their “questionable benefits are far outweighed by risks of severe liver injury and other side effects.”
If the FDA were to act as Public Citizen petitioned it to do, the move may wind up following a European example. As the organization pointed out in its Feb. 24 statement, a committee of the European equivalent of the FDA “recommended that all forms of ketoconazole be removed from the European market because the agency had concluded that the risks outweighed its limited benefits for any fungal infection.”
Public Citizen wrote that the same situation exists in the U.S., explaining, “Public Citizen learned – after obtaining an unreleased, internal agency memo – that six months before the FDA’s July 2013 announcement restricting ketoconazole, a team of FDA scientists at the Office of Surveillance and Epidemiology reached the same conclusion as the EMA: that ketoconazole should be removed from the market.”
Based on data from the Office of Surveillance and Epidemiology, the group estimated that about 600 cases of liver injury in the U.S., which led to either hospitalization or referral to a specialist, may have resulted from the 462,000 prescriptions for ketoconazole used in 2014.
“The FDA’s own experts concluded that ketoconazole was too dangerous to remain on the market – for any of its approved uses – yet the agency continues to allow hundreds of thousands of prescriptions for the medication to be filled each year, likely resulting in hundreds of preventable cases of serious liver damage,” Public Citizen health researcher Dr. Sammy Almashat said. “The FDA needs to listen to its own scientists and follow the EMA’s example in banning ketoconazole as an antifungal treatment.”
Pointing out in 2013 that topical formulations of Nizoral have not been associated with liver and adrenal injury, the FDA explained that oral Nizoral should be restricted to “the treatment of certain fungal infections, known as endemic mycoses, only when alternative antifungal therapies are not available or tolerated.”
Back in 2013, the FDA wrote this about potential Nizoral liver damage: “Nizoral tablets can cause liver injury, which may potentially result in liver transplantation or death. FDA has revised the Boxed Warning, added a strong recommendation against its use (contraindication) in patients with liver disease, and included new recommendations for assessing and monitoring patients for liver toxicity (see Additional Information sections). Serious liver damage has occurred in patients receiving high doses of Nizoral for short periods of time as well as those receiving low doses for long periods. Some of these patients had no obvious risk factors for liver disease. The liver injury is sometimes reversible upon stopping the drug, but that is not always possible.”
In regard to the adrenal risk, the FDA explained almost two years ago, “Nizoral tablets may cause adrenal insufficiency by decreasing the body’s production of hormones called corticosteroids. Corticosteroids are produced by the adrenal glands, which are small glands located on top of each kidney. Corticosteroids affect the body’s balance of water and salts and minerals (electrolytes).”
All of this means that patients who were diagnosed with a liver or adrenal injury following the use of the tablet-form antifungal Nizoral may be entitled to compensation. The product liability attorneys at Reich & Binstock have taken on the big pharmaceutical companies on behalf of its clients for 30 years, and they are skilled and well-resourced at representing these types of victims.
At no charge, one of Reich & Binstock’s experienced attorneys will investigate the patient’s circumstances and determine whether there is a viable case for a Nizoral lawsuit. For a free consultation, contact Reich & Binstock either by calling the toll-free number below or by submitting an electronic message through its website.