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WASHINGTON (AP) - The government on Monday restricted an antibiotic linked to rare reports of severe liver problems including several deaths, saying the drug should be used only to treat pneumonia and not less serious illnesses.
The Food and Drug Administration said the antibiotic, Ketek, would remain on the market but that its label will bear a new, stern warning. The agency said it and manufacturer Sanofi-Aventis SA also created a guide for patients outlining the drug's risks and its safe use.
The FDA announced the changes on the eve of a House subcommittee hearing on drug safety that will examine irregularities in the approval of Ketek.
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