Antifungals and Cardiac Risks

OB/GYN News, June 15, 2001 by Sally Koch Kubetin

The Food and Drug Administration has issued two public health advisories concerning oral antifungal agents indicated for the treatment of onychomycosis.

The agency warns of serious risks associated with the use of Sporanox (itraconazole) capsules and the development of congestive heart failure.

Further, Sporanox and Lamisil (terbinafine hydrochloride) tablets have also been linked to serious hepatic toxicity, even in some patients without preexisting liver disease or an underlying medical condition.

The FDA has received 94 reports of Sporanox patients developing congestive heart failure since September 1992. In response, the current black box warning on the Sporanox label now advises against the product's use in patients with a history of congestive heart failure or evidence of cardiac dysfunction.

Use of Sporanox has been connected to 24 cases of liver failure, including 11 deaths, while 16 cases of liver failure, also including 11 deaths and two liver transplants, have been linked to Lamisil tablets. The advisory does not apply to topical forms of Lamisil.