Antibiotic label to warn of liver danger

The label of an antibiotic will be updated to reflect reports of severe liver problems, including several deaths, its manufacturer said Thursday.

Sanofi-Aventis said the antibiotic, Ketek, will carry a bold-type warning about reports of liver failure and severe injury, some of them fatal, in patients treated with the drug. The company also will provide additional information to patients and doctors.

Sanofi-Aventis 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 four deaths, in patients treated with Ketek, according to an internal agency 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 stopped enrolling children in trials of the drug. The company has sold Ketek in the United States since 2004.