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WASHINGTON (Reuters) - U.S. lawmakers criticized the Food and Drug Administration's monitoring of the risks of the antibiotic Ketek (Sanofi-Aventis) and some other prescription drugs on Tuesday. At a hearing on the FDA's drug safety oversight, lawmakers said the agency stifled dissent about the risks of drugs when top managers disagreed. They cited problems with Ketek, Vioxx (Merck & Co. Inc.'s withdrawn arthritis drug) and antidepressants made by several companies. "With each of these drugs, it appears that the FDA is not seriously questioning whether the risks outweigh the benefits of the new drug," said Rep. Bart Stupak (news, bio,...

Associated Press NEW YORK — French pharmaceutical company Sanofi-Aventis SA said Thursday it has suspended enrollment in studies of its antibiotic Ketek in children, amid reports the drug can cause liver failure in adults. The company denied the studies were halted because of safety concerns and said it was only trying to ensure the trials' design complied with FDA requirements. The Paris-based company said the Food and Drug Administration did not request the action. It also said the suspension was not linked to a published report which said an FDA official last month requested the trials be halted because Ketek...

I need help getting a WSJ article from todays WSJ. I don't want to subscribe to it, just this one article about Sanof/Aventis and Ketek. Could someone send it to me Please. Thanks daihuy

FINDINGS Researchers reported three cases of severe liver problems yesterday, including one death, in patients at a North Carolina hospital after they began taking a novel antibiotic. The Food and Drug Administration said it was reviewing an unknown number of cases involving the drug, telithromycin, marketed as Ketek, and consulting with counterparts overseas. The FDA approved the drug in 2004. One patient at Carolinas Medical Center in Charlotte died after taking telithromycin. Another required and received a liver transplant, while the third recovered from drug-induced hepatitis after treatment with Ketek was stopped. --snip-- Oral Cancer Study False, Journal Says The...