NEW YORK, May 19 (UPI) -- The U.S. Food and Drug Administration has linked Sanofi-aventis' drug Ketek to 12 cases of liver failure, the Wall Street Journal reported.
According to the newspaper, the FDA is considering adding a strong new warning to the antibiotic that "severe, life-threatening, and in some cases, fatal" liver toxicity has been reported in some patients.
Congress is already probing the clinical data on which the FDA relied to approve Ketek. Specifically, Senate lawmakers led by Charles Grassley, R-Iowa, and others are particularly questioning a large clinical study submitted to support Ketek's safety and efficacy that was clouded by suspicions of fraudulent data.
The agency threw out the study but still approved Ketek for market in April 2004, the WSJ said.
Ketek was prescribed 3.35 million times in the United States last year and generated sales of $193 million, the report said, quoting statistics from IMS Health.
