Defective Drugs Cases...
Sporanox Related Side Affects....

   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.

   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.

The FDA received the following event reports:

1) 94 cases in which patients receiving Sporanox developed CHF
2) In 58 of the 94 cases, FDA believes Sporanox contributed to or may have been the cause of CHF.
3) In 26 of these 58 cases, Sporanox was being administered to treat fungal nail infections.
4) 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.

   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.

Other Names:
Itraconazole

Adverse Effects/ Potential Injuries:
Congestive Heart Failure
Death
Liver Failure

Related Terms:
Lamisil

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