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participating institutions:
Johns Hopkins University AIDS Service, New York State DOH AIDS Institute, The CORE Center, Cook County Hospital



NEWS AND NEW DEVELOPMENTS



FDA warning on safety of Itraconazole (Sporanox)
The FDA noted that some animal model studies and trials in healthy humans showed that Itraconazole was associated with a negative inatrophic effect. On the basis of this, the Agency reviewed the data from "Drug Watch" which showed 58 cases of congestive heart failure associated with Itraconazole. Of these, 28 patients were hospitalized and 13 died, but the deaths were associated with other confounding variables that precluded any clear conclusions. The Agency is also aware of rare cases of hepatic failure with the use of Itraconazole and Lamisil. The special concern in these cases is the use of these drugs for nail infections where the risk-benefit may be seriously questioned. The result is a "black box warning" concerning the Sporanox for onychomycosis in patients with cardiac dysfunction. The new labeling with both Sporanox and Lamisil will warn about hepatotoxicity and recommend that the diagnosis be confirmed with laboratory testing prior to prescribing.
posted 6/1/2001





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