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.
What are some warning signs of congestive heart failure?
Shortness of breath
Swelling of the feet, ankles, legs, or abdomen
Coughing up of white or pink mucous
Unusual fast heartbeats
What are some warning signs of liver failure?
Loss of appetite
Generalized skin discoloration
If I develop heart or liver problems, do the warning signs happen while on drug treatment or can they develop years after stopping treatment?
Based on data known at present, the warning signs are most likely to be present while taking the drug or soon after stopping it.
The FDA has created MedWatch, the FDA Medical Products Reporting Program, to educate all health professionals about the critical importance of being aware of, monitoring for, and reporting adverse events and problems to FDA and/or the manufacturer. While participation in MedWatch is voluntary, FDA encourages anyone aware of a serious adverse reaction, including consumers, to make a MedWatch report.
You can report an adverse event in two ways:
and click on "How to Report"
I only have a few days left of Sporanox. Although I was at the hospital today for an unrelated matter, my heart was fine while it was being monitored during a heart test. I did not have the heart test because I was having heart problems or Sporanox side effects. It was just to check my heart out since I never checked it out before. I only have a few days left of Sporanox so I might stop taking it tomorrow. I do not know.
Please keep us updated. I hope everything is ok.
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