The U.S. Food and Drug Administration reviewers have linked Sanofi-Aventis SA’s antibiotic Ketek to 12 cases of liver failure, including four deaths, and is now recommending the company put a warning label on the drug, the Wall Street Journal said on Friday.
The paper said the cases were reported in a May 16 memo which it has seen from the FDA’s Division of Drug Risk Evaluation.
The company said it “continues to believe that Ketek is safe and effective when used as directed,” according to a company statement issued to the Journal.
No one could be immediately reached for comment at Sanofi in Paris.
U.S. lawmakers have questioned the FDA’s 2004 approval of the drug amid charges of faulty data from one of the trials.
Ketek, which was approved to treat respiratory infections, drew renewed scrutiny in January when researchers reported that three patients using the drug developed severe liver damage and one died.
The FDA rejected the drug in 2001 and 2003, asking for more safety information.
A U.S. representative for Sanofi-Aventis could not immediately be reached for further comment.