Antifungal Medications

Why Don’t Doctors Always Prescribe Antifungal Medications?

Oral antifungal medications are typically taken over a period of several months. They are only prescribed if a doctor is satisfied there is no risk of the drugs causing interactions with any other medications you might be taking.

In addition your doctor will ensure there is no existing impairment of your liver or kidneys, or history of certain heart problems such as abnormal heart rhythms or congestive heart failure.

Doctors need to be satisfied on these matters because oral antifungal medications can cause serious interactions with other drugs and can lead in rare cases to serious liver and heart complications including death.

In May of 2001, a United States government department known as the ‘Food and Drug Administration’ (FDA) issued new guidelines on the potential risks to the heart associated with taking the medications itraconazole (Sporanox), and the potential risks to the liver associated with both itraconazole and terbinafine (Lamisil). The circumstances that led to the new guidelines were due to serious medical complications and deaths of some patients taking oral anti-fungal drugs.

The text below is comprised of extracts reproduced from the FDA directive – May 2001.

The FDA issued a Public Health Advisory to announce important safety-related updates to the labelling 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® labelling 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 prompted the labelling updates for Sporanox® and Lamisil®?

Sporanox® Cardiac Risk Labelling Update:

®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 Labelling 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. – FDA May 2001

Over the last five years both itraconazole and terbinafine have been the main treatment options for fungal nail infection affecting the nail bed. However there is now a new safe topical alternative in the form of the PinPointe infrared laser treatment. This new treatment has a higher efficacy rate than oral antifungal medications and to date has no reported side effects or risks. It is also available to patients who have had to discontinue oral medication due to side effects or for the 40-50% of cases where the antifungal medications have simply not worked.

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