The Food and Drug Administration is raising the red flag over Johnson & Johnson’s anti-fungus pill Nizoral, in light of the risk of severe liver and adrenal gland injuries, as well as dangerous drug interactions.
According to the FDA, the boxed label warning for the drug, which is marketed as Nizoral and known generically known as “ketoconozale,” was not sufficient to warn prescribing physicians and their patients of the potential drug hazards. The new warnings apply only to the drug in pill form that are taken by mouth — not topical formulations, including creams, shampoos, foams, and gels.
The label will be revised to specify that Nizoral tablets should only be used for fungal infections when other medications are not available or otherwise contraindicated for use with the particular patient. Essentially, the FDA is putting prescribers and their patients on notice that in many cases, the risk Nizoral poses in many cases may be greater than its benefits, and that doctors should consider less risky alternatives.
The Wall Street Journal is reporting that Johnson & Johnson, suspended the manufacturing of the tablets before the FDA announcement.