July 1, 2001 - Safety Alert Issued on Sporanox and Lamisil
The FDA alerted physicians prescribing a tablet form of itraconazaole (Sporanox), manufactured by Janssen Pharmaceutica and Ortho Biotech, and terbinafine HCl (Lamisil), produced by Novartis, of serious health risks to their patients. Generally, these drugs are offered in a form of a cream or an ointment and are safe and effective in treating fungal infections. However, the agency warns, a pill form of these medications could possibly cause some severe health problems like heart and liver failure in some patients.
The agency further commented that "there is a small but real risk of developing congestive heart failure (CHF) associated with the use of Sporanox, and that both Sporanox and Lamisil have been associated with serious liver problems resulting in liver failure, transplantation, and death. However, there is insufficient data to allow the FDA to make any kind of statement about the comparative safety of Sporanox and Lamisil."
The agency's warning reports are mostly based on 94 studied cases in which patients who took Sporanox had later developed CHF. The FDA further states that in more than half of the studied cases, Sporanox might have caused or contributed to CHF and that 28 patients who used it for fungus were hospitalized and 13 died.
Based on this information, the FDA now requires companies manufacturing Sporanox to label its product and warn patients using it for fungal nail infection not to take it if they have a history of congestive heart failure or develop a cardiac dysfunction after taking the drug.
The FDA had also reviewed a small number of cases where patients who took Lamisil had also developed some severe health complications, including 11 recorded studies that resulted in death. These case studies possibly connect Lamisil to liver failure in patients that took Lamisil tablets. The agency further advises doctors to use lab testing and verify their diagnosis of fungal nail infections before they prescribe either Sporanox or Lamisil tablets.
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