Less than a week ago, an online advisory notice was posted by the Food and Drug Administration (FDA) warning both pharmaceutical researches and drug companies alike against the use oral ketoconazole in their trials and examinations of between-drug interactions. Nizoral, the brand name for oral ketoconazole, has been connected to instances of adrenal gland dysfunction and liver injury. Accordingly, the FDA has advised that other drugs be used in substitution of oral ketoconazole, the anti-fungal agent found in creams, foams, shampoos, gels, and oral tablets.
First approved by the FDA in June of 1981, Nizoral – or oral ketoconazole – is a synthetic antifungal agent that has since come under a great deal of scrutiny from drug safety monitors. In July of this year, the FDA ruled that Nizoral tablets be used only by patients who’ve been diagnosed with endemic mycoses and only when no other alternative treatment options are available. Using data collected by the FDA Adverse Event Reporting System (FAERS), the following information was identified in conjunction with the use of Nizoral:
- 359 serious adverse events
- 96 cases of hepatic disorders
- 11 cases of adrenal gland disorders
The Drug Safety Communication issued by the FDA warned of the potential for fatal liver damage among users of Nizoral and its generic counterpart, oral ketoconazole. The CYP3A inhibitor affects the user’s ability to metabolize certain types of drugs. However, given the toxicity of ketoconazole, the FDA is recommending that other, less toxic versions of CYP3A inhibitors be used instead. Common alternatives that have been deemed to be safer for use include clarithromycin and itraconazole.