Seborrheic Dermatitis

On May 9, 2001. The Food and Drug Administration (FDA) issued a
Public Health Advisory to announce significant safety-related updates
to the labeling of Sporanox products and Lamisil tablets. Sporanox
and Lamisil are used to treat nail (onychomycosis), skin and other
systemic fungal infections.

Potential Heart Damage

The FDA believes there is real risk of developing congestive heart
failure (CHF) associated with the use of Sporanox. Both Sporanox and
Lamisil have been associated with serious liver problems resulting in
liver failure, transplantation and even death.

Results of recent studies of Sporanox showed that the drug can weaken
the force of the heart muscle’s contractions. This condition,

sometimes called "negative inotropic effect" was observed when
Sporanox was injected intravenously into anesthetized dogs and
healthy human volunteers. In these studies, the adverse effect on the
heart muscle resolved once the drug was stopped.

Since becoming aware of the study findings, the FDA analyzed US and
international post-marketing adverse event reports involving Sporanox
that were received between its approval in September 1992 and April
2001.

During this period, FDA received the following event reports:

94 cases in which patients receiving Sporanox developed CHF
In 58 of the 94 cases, FDA believes Sporanox contributed to or may
have been the cause of CHF.
In 26 of these 58 cases, Sporanox was being administered to treat
fungal nail infections.
Of these 58 patients, 28 were hospitalized. Death was reported in 13
cases.
In response to the study findings and the analysis of the post-
marketing adverse event reports, the FDA has added additional
information to the current warning in the Sporanox labeling. The
warning now states that Sporanox should not be administered for the
treatment of fungal nail infections in patients with evidence of
cardiac dysfunction, such as CHF, or a history of CHF.

The revised Sporanox warning also includes important information
about heart-related adverse events caused by drug interactions. If
signs and symptoms of CHF occur during treatment of fungal nail
infections, the revised labeling recommends that the use of Sporanox
should be discontinued.

Potential Liver Damage

The advisory also alerts healthcare professionals to rare cases of
serious liver problems including liver failure, transplantation and
death associated with the use of Sporanox products and Lamisil
tablets.

While adverse liver effects were previously included in the labeling
for both products, the FDA decided to include this information in the
advisory because some cases involved patients with no preexisting
liver disease or any serious underlying medical condition.

As of March 2001, FDA has received and reviewed 24 cases of liver
failure possibly associated with Sporanox, including 11 deaths. In
almost half of the liver failure cases, subjects received Sporanox
for fungal nail infections or other dermatological infections.

Given the possible serious risks associated with Sporanox products
and Lamisil tablets, the new labeling for both products now
recommends that healthcare professionals should obtain nail specimens
for laboratory testing prior to prescribing the medications for
fungal nail infections, to confirm the diagnosis.

This entry was posted on Friday, December 31st, 2004 at 6:14 am and is filed under Uncategorized. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.