FDA calls for stricter warnings on antibiotic after liver failure reports

An antibiotic linked to a growing number of reports of liver failure, including four deaths, should carry stricter warnings about its effect, according to an internal US Food and Drug Administration memo.

The drug’s manufacturer, Sanofi-Aventis, said it was in talks with the FDA officials about the reports.

The FDA has received reports of 12 cases of acute liver failure, including the four deaths, in patients treated with Ketek, according to a copy of the memo shown to The Associated Press.

FDA safety evaluators also uncovered 23 other cases where patients suffered serious liver injuries after receiving the antibiotic, which is formally called telithromycin.