- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
Safety Concerns Limit Use of Antifungal Drug, Nizoral (Ketoconazole)
FDA approves label changes (July 26)
The FDA has taken several actions related to Nizoral (ketoconazole, Johnson & Johnson) oral tablets, including limiting the drug’s use, warning that it can cause severe liver injuries and adrenal gland problems, and advising that it can lead to harmful drug interactions with other medications. The agency has approved label changes and has added a new Medication Guide to address these safety issues.
As a result, Nizoral oral tablets should not be a first-line treatment for any fungal infection, the agency says. The drug should be used for the treatment of certain fungal infections, known as endemic mycoses, only when alternative antifungal therapies are not available or tolerated.
The topical formulations of Nizoral have not been associated with liver damage, adrenal problems, or drug interactions. These formulations include creams, shampoos, foams, and gels applied to the skin, unlike the Nizoral tablets, which are taken by mouth.
The FDA warns that the tablets:
- Can cause liver injury, which may potentially result in liver transplantation or death
- May cause adrenal insufficiency by decreasing the body’s production of corticosteroids
- May interact with other drugs
- Can result in serious and potentially life-threatening outcomes, such as heart-rhythm problems
Source: FDA; July 26, 2013.