The EMEA posted a press release on its website Friday and asked sanofi-aventis to revise labeling for antibiotic Ketek to include stronger warnings for liver disorders. The EMEA reviewed cases of serious liver injury associated with use of Ketek.
The EMEA said its actions are precautionary. There have been reports of serious acute hepatitis, including liver failure, some of which were fatal. The serious liver reactions started during or immediately after using Ketek and in most cases were reversible after patients stopped taking the drug.
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