FDA recommends Ketek warning label: WSJ

NEW YORK/PARIS (Reuters) – 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, where Sanofi shares were down 1.4 percent at 72.65
euros at 0849 GMT, making them the third biggest loser in the
CAC-40 index of leading French shares.

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.