Awareness of ketoconazole’s risks may be low among endocrinologists

Results from a small survey suggest that endocrinologists were unaware of the safety risks, including adrenal gland problems, associated with the antifungal ketoconazole.

In July 2013, the FDA suggested that use of oral ketoconazole tablets be limited due to its potential to cause severe liver injuries, adrenal insufficiency and serious drug interactions when taken with other medications, according to a drug communication from the agency. On Oct. 16, 2013, the FDA issued another warning recommending against the use of ketoconazole in drug interactions and said other strong CYP3A inhibitors are available as alternatives.

Researchers surveyed 10 endocrinologists who have experience with ketoconazole and are currently treating patients with Cushing’s syndrome. Of those included, five were unaware of the original FDA safety alert and eight have used the drug off-label as first-line therapy for Cushing’s syndrome, according to a press release.

After discussion of the FDA alert, none of the respondents were comfortable with using the drug as first-line treatment. Additionally, eight expressed significant concern about the risks associated with ketoconazole and eight also were concerned about the mandatory weekly liver monitoring during treatment with the drug. All respondents felt the news was important and relevant for all practicing endocrinologists.

Four respondents were in hospital-based practice; three were in group private practice, two were in an academic institution-based practice and one was in solo private practice.