Ketek Drug

A Republican senator said he suspected that the Food and Drug Administration was withholding information about its review of Sanofi-Aventis' antibiotic Ketek, which has been linked to liver damage. "I smell a cover-up," said Finance Committee Chairman Charles E. Grassley of Iowa after the FDA did not make one of its investigators available for a meeting. An FDA spokesman said the staffer was not available because the investigation was still underway.

Four deaths from liver failure linked to a new antibiotic have renewed concerns about the nation's drug safety program, leading some experts to question the effectiveness of internal fixes made at the Food and Drug Administration since the withdrawal of the discredited painkiller Vioxx. "This is another example that we should see as a signal that the current system needs reform," said Arthur A.

Sanofi-Aventis has put a stronger warning on its antibiotic Ketek after the deaths of four patients who took the drug and developed liver failure, U.S. regulators said. Liver failure was reported in eight other Ketek users, including one who required a liver transplant as a result, the Food and Drug Administration said. Twenty-three others developed less serious liver damage, the FDA said.

A Food and Drug Administration meeting to review whether a recently approved antibiotic carries an unacceptably high risk of liver failure raised questions Thursday about the credibility of the agency's internal decision-making. The antibiotic, Ketek, was approved in 2004 to treat pneumonia and other severe respiratory infections. It appeared promising as a weapon against microbes resistant to older antibiotics.

In another setback for the Food and Drug Administration's drug safety program, government medical advisors recommended Friday that sharp restrictions be placed on the use of a once-promising antibiotic that helps patients with respiratory infections but has also been linked to cases of sudden liver failure.