WASHINGTON – A consumer safety group is calling on the Food and Drug Administration to pull certain antifungal tablets off the market, because of risks of liver damage.
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Public Citizen is filing a petition asking the FDA to ban ketoconazole tablets, which are used against hard-to-treat fungal infections. First approved in 1981, the drug has long carried a boxed warning about potentially fatal liver damage. In July 2013, the FDA restricted ketoconazole's use to certain infections that do not respond to other drugs.
But Public Citizen notes that European regulators went further, removing all oral versions of the drug from the market.
The group is requesting similar action from the FDA, noting there are safer antifungal options. Last year U.S. patients filled 462,000 prescriptions for ketoconazole tablets, according to Public Citizen.