Nizoral Oral Tablets Warning

CaseyGerry has a strong history in drug litigation in high-profile such as the case below. We are currently not accepting new clients for this case. 

The Pharmaceutical and Medical Device team at CaseyGerry is currently evaluating and accepting cases against Johnson & Johnson, the makers of Nizoral (ketoconazole) oral tablets, which are used to treat fungal infections, and can cause liver injury, potentially resulting in liver transplant or death.

The Food and Drug Administration (FDA) reports that during 2012 alone, approximately 5.2 million Nizoral (ketoconazole) prescriptions were dispensed, of which 609,000 (12%) were for the tablet formulation. Safety Announcement

The Warning:

The FDA has revised its boxed warning for Nizoral tablets – stating that Nizoral oral tablets should not be a first-line treatment for any fungal  infection and adding a strong recommendation against its use in patients with liver disease, with new recommendations for assessing and monitoring patients for liver toxicity.

According to the FDA, Nizoral can cause severe liver injuries and adrenal gland problems, as well as lead to dangerous drug interactions with other medications, causing serious and potentially life-threatening outcomes such as heart rhythm problems. As a result, the FDA  recently approved the label changes and added a new Medication Guide to address safety concerns. Nizoral Risks

The label now states, “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.” The FDA also requires that the label include a new contraindication that patients with liver disease should not use Nizoral.

Additionally, The European Medicines Agency’s Committee on Medicinal Products for Human Use (CHMP) recommended against continued sale of ketoconazole-containing products in Europe. The CHMP concluded that the risk of liver injury is greater than the benefits in treating fungal infections.

Background

Nizoral (Ketoconazole) is used to treat fungal infections – such as yeast infections of the mouth, skin, urinary tract, and blood – that begin on the skin or in the lungs and can spread to different parts of the body through the bloodstream. Also used to treat fungal infections of the skin or nails that cannot be treated with other medications, it is in a class of antifungals called imidazole and  works by slowing the growth of fungi that cause infection.

Serious liver damage has occurred in patients receiving high doses of the drug for short periods of time as well as those receiving low doses for long periods. Symptoms of drug induce liver damage may include nausea, vomiting, loss of appetite, weakness,  jaundice and pain or discomfort in the right upper abdomen, where the liver is located.

In addition, these tablets may cause adrenal insufficiency by decreasing the body’s production of hormones called corticosteroids – which affect the body’s balance of water and salts and minerals (electrolytes).