What prompted the labeling updates for Sporanox® and Lamisil®?
These labeling changes are based on a safety evaluation of preclinical, clinical and post-marketing information.Sporanox® Cardiac Risk Labeling Update:As of April 2001, FDA has reviewed 94 cases in which Sporanox® treated patients developed congestive heart failure. In 58 of the 94 cases, FDA believes Sporanox® contributed to or may have been the cause of the congestive heart failure. Although the causal relationship is unclear, death was reported in 13 cases.Sporanox® and Lamisil® Hepatic Risk Labeling Update:As of March 2001, the FDA has reviewed 24 cases of liver failure possibly associated with Sporanox® use, including 11 deaths. As of April 2001, the FDA has reviewed 16 possible Lamisil® associated cases of liver failure, including 11 deaths and two liver transplant patients.
These labeling changes are based on a safety evaluation of preclinical, clinical and post-marketing information.Sporanox® Cardiac Risk Labeling Update:As of April 2001, the FDA has reviewed 94 cases in which Sporanox® treated patients developed congestive heart failure. In 58 of the 94 cases, the FDA believes Sporanox® contributed to or may have been the cause of the congestive heart failure. Although the causal relationship is unclear, death was reported in 13 cases.Sporanox® and Lamisil® Hepatic Risk Labeling Update:As of March 2001, the FDA has reviewed 24 cases of liver failure possibly associated with Sporanox® use, including 11 deaths. As of April 2001, the FDA has reviewed 16 possible Lamisil® associated cases of liver failure, including 11 deaths and two liver transplant patients.
