The U.S. Food and Drug Administration (FDA) issued a stern warning to patients who take Janssen Pharmaceutical’s Nizoral (generic name ketoconazole) oral tablets. In fact, the FDA issued a safety release advisiong that Nizoral should not be the initial treatment for any fungal infection. During 2012, approximately 5.2 million ketoconazole prescriptions were dispensed, of which 609,000 were for tablet formulation.
According to the FDA, Nizoral tablets can cause liver injury, which could potentially result in liver transplantation or death. The FDA has revised the Box Warning to strongly recommend against its use in patients with liver disease, and included new recommendations for assessing and monitoring patients for liver toxicity.
With regard to Adrenal Gland Problems, Nizoral tablets may cause adrenal insufficiency by decreasing the body’s production of hormones called corticosteroids. The FDA is encouraging healthcare professionals to monitor adrenal function in patients taking Nizoral tablets who have existing adrenal problems or in patients who are under prolonged periods of stress such as those who have a recent major surgery or who are under intensive care in the hospital
Based on the above risks, the drug label for Nizoral tablets have been updated to include the following information, inter alia:
•Limitation of the usage of Nizoral tablets by removing indications in which the risk outweighs the benefits.
•Nizoral tablets are now only indicated for the treatment of the following fungal infections: blastomycosis, coccidioidomycosis, histoplasmosis, and paracoccidioimycosis in patients in whom other treatments have failed or who are intolerant to other therapies.
•Nizoral tablets are no longer indicated for the treatment of fungal infections of the skin or nails.
•A new contraindication that Nizoral tablets should not be used in patients with acute or chronic liver disease.
•A warning regarding adrenal insufficiency with recommendation for monitoring populations at risk.
The European Medicines Agency (EMA) also announced their negative risk-benefit assessment for oral ketoconazole-containing medicines used to treat infections caused by dermatophytes and yeasts and recommended suspensions of these medicines throughout the EU. EMA has concluded that the benefit of oral ketoconazole does not outweigh risk of liver injury in fungal infections. This begs the questions, what did Janssen Pharmaceutical know about the risks of Nizoral?
If you or a loved one has experienced a liver injury or adrenal issues due to Nizoral, please contact Pogust Braslow & Millrood for a free consultation at (610) 941-4204 or on our website: www.pbmattorneys.com