Sporanox and Lamisil Public Health Advisory, Questions and Answers.
What is the Food and Drug Administration (FDA) announcing today?
The FDA issued a Public Health Advisory to announce important safety-related updates to the labeling of Sporanox® (itraconazole) and Lamisil® (terbinafine hydrochloride) Tablets.
FDA is advising healthcare professionals not to prescribe Sporanox® to treat fungal infections (onychomycosis) in patients who have congestive heart failure (CHF) or a history of CHF. The updated Sporanox® labeling also includes contraindications and precautions with certain medicines.
FDA’s advisory also alerts the public that both Sporanox® and Lamisil® Tablets have been associated with serious liver problems including liver failure and death.
What are Sporanox® Capsules and Lamisil® Tablets used for?
Sporanox® Capsules and Lamisil® Tablets are prescription medicines approved to treat toe and finger nail fungal infections. Sporanox® Capsules, Oral Solution, and Injection are also approved to treat serious fungal infections that may occur in other parts of the body.
Lamisil® is also available as cream and solution. This Public Health Advisory does NOT apply to these topically applied dosage forms.
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.
What are some warning signs of congestive heart failure?
- Shortness of breath
- Swelling of the feet, ankles, legs, or abdomen
- Weight gain
- Unusually tired
- Coughing up of white or pink mucous
- Unusual fast heartbeats
What are some warning signs of liver failure?
- Abdominal pain
- Loss of appetite
- Dark urine
- 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.
Are there other treatments for my nail fungus that are safer?
No drug product is "perfectly" safe. Every single drug that affects the body will have some side effects.
For every drug FDA approves, the benefits are balanced against its risks. In addition, FDA makes sure the labeling (package insert) outlines the benefits and risks reported in the tested population and is updated, as new information becomes available. You and your healthcare professional should decide together if the benefits outweigh the risks for YOU based on the new safety information for Sporanox® and Lamisil®.
The new labeling for both Sporanox® and Lamisil® recommends that healthcare professionals obtain nail specimens for laboratory testing to confirm the diagnosis of onychomycosis before prescribing the medications for this indication.
What actions have FDA and the manufacturers taken to make the public aware of this safety information?
FDA has worked with the manufacturers of Sporanox® and Lamisil® to:
- Revise the professional labeling to inform health care providers about these possible serious side effects, describe the types of patients that should not receive Sporanox® or Lamisil®, and explain when Sporanox® or Lamisil® therapy should be stopped.
- Distribute a "Dear Health Care Professional" letter which the manufacturers will send to health care providers to convey new information on safety.
What should I do if I am currently taking Sporanox® or Lamisil®?
Tell your doctor about any side effects you experience while taking Sporanox® or Lamisil®.
Any decision about which drug product to take to treat your nail fungus should be made in consultation with your doctor based on an assessment of your specific treatment needs, specific risk profile, and other factors.
How can I report a serious side effect to the FDA?
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:
- Visit www.fda.gov/medwatch and click on "How to Report"
- Call 1-800-FDA-1088