PARIS, May 19 (Reuters) - French drug maker Sanofi-Aventis confirmed on Friday that it was in talks with the U.S. Food and Drug Administration about its antibiotic Ketek, following a report the regulator wanted a warning label on the drug.
The Wall Street Journal, citing an internal FDA memo, reported that Ketek had been linked to 12 cases of liver failure, including four deaths, and that the FDA was recommending that the company put a warning label on the drug.
"Sanofi continues to believe that Ketek is safe and effective," said a company spokesman in Paris. "We are in talks with the FDA to evaluate secondary effects on the liver; and, as we are in discussions, we are not going to start commenting on these figures."
He said that all secondary effects were reported to the FDA, and that talks on labeling had been going on for several months. He said that the company did not have a copy of the memo cited by the newspaper.
The Wall Street Journal said that 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 that one died.
The FDA rejected the drug in 2001 and 2003, asking for more safety information.
Sanofi shares were down 0.5 percent, at 73.10 euros, by 1247 GMT.
Posted by treepatrol (Member # 4117) on :
I held off for over a year and a half from taking this one then I took it for 2 months nothing like putting the genie back in the bottle. ah crud
Posted by AZURE WISH (Member # 804) on :
I am glad they are just trying to put a warning label on it and not trying to take it off the market.
It would be horrible if they took it off the market.....at least for me. Posted by luvs2ride (Member # 8090) on :
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