May 10,2001 WASHINGTON (AP) - The government issued a health warning about potential problems associated with two drugs widely used to treat fungal infections of the nails and skin.
The Food and Drug Administration is requiring that labels for the prescription drugs Sporanox and Lamisil carry stronger warnings about potential liver damage, and labels for Sporanox also cite potential heart damage.
New labeling for Sporanox will state that it should not be used in patients with heart disease.
The agency, in a statement, said it believes "there is a small but real risk of developing congestive heart failure associated with the use of Sporanox."
The new labeling for both drugs strengthens current warnings of serious liver problems, including liver failure and death, associated with Sporanox products and Lamisil tablets. The warnings do not apply to the cream or solution versions of Lamisil.
The FDA said studies found that the drug has the potential to weaken the force of the heart muscle contractions, an effect that stopped when the drug was no longer used.
After learning of that problem, the agency reviewed reports of problems in people who used the drugs between its introduction in 1992 and last month.
It found 94 reports of patients developing congestive heart failure. The FDA said it believes that the drug contributed to the disease in 58 cases. These included 13 deaths, although the FDA said that "the causal relationship between the 13 deaths and Sporanox is very unclear."
Ten of those who died had other serious health problems. Doctors will be told that because of the possibility of serious liver problems they should get a laboratory analysis to confirm the diagnosis of a fungal infection before prescribing the either drug.
The agency said it has reviewed 16 possible Lamisil-associated cases of liver failure including 11 deaths and 24 cases of liver failure possibly associated with Sporanox, also including 11 deaths.
Physicians are being sent letters advising them of the new warnings by the manufacturers of the drugs. Sporanox is made by Janssen Pharmaceutica Inc., of Titusville, N.J. Lamisil is a product of Novartis Pharmaceuticals of East Hanover, N.J.
Copyright 2001 The Associated Press. All rights reserved.
