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Antifungal Nizoral (ketoconazole) dangers known as early as 1998

The FDA issued a last week, but the risks surfaced in research as early as 1998.

The study called “Ketoconazole-induced Liver Damage” conducted by physiciansKetoconazole induced liver damage journal article title in Argentina noted two deaths, with liver toxicity, then with one patient who developed “massive necrosis with fulminant liver failure and other, submassive necrosis.” Although the study had few patients, the study was considered significant enough to warn physicians in that country to monitor liver function early with any use of the drug.

Also last week, the European counterpart to the FDA, the European Medicines Agency (EMA) recommended suspension of the drug as well as marketing authorizations for any further promotion by the manufacturers.

Links

FDA Drug Safety Communication: FDA limits usage of Nizoral (ketoconazole) oral tablets due to potentially fatal liver injury and risk of drug interactions and adrenal problems” by Calvin Chong, MedicalSEA, August 4, 2013

European Medicines Agency recommends suspension of marketing authorisations for oral ketoconazole: Benefit does not outweigh risk of liver injury in fungal infections” Official press release, July 26, 2013

 

 

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