Antiobiotic label to bear severe warning of liver problems

The label of an antibiotic linked to reports of liver failure, including at least four deaths, will be updated with the strictest warning prescription drugs can bear, its manufacturer said Thursday.

France-based Sanofi-Aventis said the antibiotic, Ketek, will carry a so-called "black-box" warning about reports of its effects on the liver. The company said it believes the drug's benefits still outweigh its risks.

The Food and Drug Administration has received reports of 12 cases of acute liver failure, including the four deaths, in patients treated with Ketek, according to an internal memo.

FDA safety evaluators also uncovered 23 other cases where patients suffered serious liver injuries after receiving the antibiotic, also called telithromycin. The reports, when considered in proportion to the number of prescriptions filled for Ketek, exceed what's been seen in similar antibiotics, according to the memo.

The Senate Finance Committee is investigating allegations of fraud connected with trials of Ketek.

Earlier this month, Sanofi-Aventis, the third largest drug maker, stopped enrolling children in trials of the drug. The company has sold Ketek in the United States since 2004, reports AP.

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