FDA Wants Warning on Ketek
The U.S. Food and Drug Administration has sent a memo to Sanofi-Aventis asking the French drugmaker to put a strongly worded warning label on its antibiotic Ketek after finding 12 cases of liver failure, including four fatalities, according to reports Friday.
Safety regulators from the FDA’s Division of Drug Risk Evaluation identified cases of liver injury that set in just a few days after patients began taking the drug, according to The Wall Street Journal. The drug was linked to four fatalities
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