U.S. health regulators have placed strict limits on the use of oral Nizoral tablets after a review indicated the prescription anti-fungal medication causes potentially fatal liver injuries, as well as adrenal gland problems and dangerous drug interactions. In a communication issued on July 26th, 2013, the U.S. Food & Drug Administration (FDA) cautioned that Nizoral tablets should never be a first-line treatment for any fungal infection.
Nizoral, which is marketed by Johnson & Johnson, is also sold in topical formulations, including creams and shampoos. Those versions of the drug are not affected by the FDA’s new warnings.
While the FDA has taken drastic steps to limit the use of Nizoral tablets, it appears the drug will remain on the market in the U.S. However, European regulators have recommended that marketing of Nizoral tablets be suspended entirely. In a statement that was also issued on July 26th, the European Medicines Agency’s Committee on Medicinal Products for Human Use warned that the risk of Nizoral liver injury outweighs any benefits associated with its use.
Nizoral Liver Injury Warnings
According to the FDA, a new Black Box Warning regarding liver injury that may result in transplantation, or even death, has been added to the label of Nizoral tablets. A Black Box Warning is the FDA’s most serious drug safety warning, and signifies that medical studies indicate that the drug carries a significant risk of serious or even life-threatening side effects. Because of the risk of Nizoral liver injuries, the new Black Box label will state that the oral tablets should never be a first choice for treating fungal infections, and advises that Nizoral “is only appropriate for certain fungal infections, known as endemic mycoses, only when alternative antifungal therapies are not available or tolerated.”
The Black Box also includes a contraindication against the use of Nizoral tablets in patients who suffer from pre-existing liver disease, and removes indications for dermatophyte and Candida infections. It further states that Nizoral should only be used to treat certain other infections when other anti-fungal treatments have failed or are not tolerated.
The FDA deemed the new Black Box label necessary after it completed a comprehensive benefit-risk assessment of the safety and efficacy of Nizoral. Among other things, data retrieved from the FDA Adverse Event Reporting System indicated that the risk of Nizoral liver injury was higher compared to the risk associated with other antifungal medications. The FDA also reviewed a published study in the U.K. General Practice Research Database that suggested a risk of acute liver injury of approximately 1 in 500 patients. In addition, the agency said that an analysis of liver transplantation data indicated that Nizoral liver injury accounted for proportionately more liver transplants than liver injuries associated with other antifungal drugs.
Other Nizoral Side Effects
The Nizoral tablet label has also been revised to include a recommendation that doctors monitor adrenal function in patients who have existing adrenal problems or who are under prolonged periods of stress. According to the FDA, reports have indicated that the use of Nizoral tablets can decrease corticosteroid production and cause adrenal insufficiency. Finally, the label now states that the use of Nizoral tablets is contraindicated in patients taking dofetilide (Tikosyn), quinidine, pimozide (Orap), and cisapride (Propulsid). According to the FDA, all medications that a patient is currently taking should be assessed for possible interactions with Nizoral tablets, as it may interact with other drugs to cause serious and potentially life-threatening outcomes, such as heart rhythm problems.
Legal Help for Nizoral Injuries
Gilman Law LLP is offering free legal consultations to individuals who suffered liver injuries, adrenal gland problems, or dangerous drug interactions that may have been associated with the use of Nizoral tablets. To ensure the statute of limitations on their claim does not run out, potential plaintiffs should contact the firm immediately. Once the statute of limitations expires, Nizoral victims who haven’t filed suit will be unable to recover damages for their injuries. Free Nizoral lawsuit consultations are available by filling out the form on this page, or calling toll free at 1-888-252-0048.