Sporanox: Frequently Asked Questions
What has the Food and Drug Administration (FDA) announced recently in relation to Sporanox and Lamisil?
The FDA issued a Public Health Advisory to announce important safety-related updates to the labeling of Sporanox (itraconazole) and Lamisil (terbinafine hydrochloride) Tablets. The 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. The 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, 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.
What are some warning signs of congestive heart failure?
Warning signs for congestive heart failure may include, but are not limited to, shortness of breath, swelling of the feet, ankles, legs, or abdomen, weight gain, fatigue, coughing up of white or pink mucous, or unusually rapid heartbeats.
What are some warning signs of liver failure?
Warning signs of liver failure may include, but are not limited to, nausea, vomiting, abdominal pain, fatigue, loss of appetite, dark urine, or generalized skin and eye 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 the FDA approves, the benefits are balanced against its risks. In addition, the 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 the FDA and the manufacturers taken to make the public aware of this safety information?
The 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 who should not receive Sporanox or Lamisil, and explain when Sporanox or Lamisil therapy should be stopped and 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.
Should I contact an attorney if I experienced severe side effects after taking Sporanox or Lamisil?
Perhaps. It may be important for you to contact an attorney who can help you protect your legal rights. Only a licensed attorney can evaluate whether you have a case worth pursuing. Keep in mind however that there may be time limits (Statute of Limitations) which affect your ability to sue.
How much does an attorney evaluation cost in these types of cases?
Nothing! Attorneys associated with InjuryBoard.com will evaluate your case free of charge. If a participating attorney agrees to handle your case, you will owe no fees or other costs unless that attorney recovers money for you.
How do I submit my case for a free evaluation?
Simply click on the free Ask an Attorney button and complete the online intake form. An attorney will evaluate your case and respond to you via email.
-- Article Courtesy of InjuryBoard.com
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