And Sanofi-Aventis Suspends Enrollment In A Pediatric Clinical Trial

In May and June 2006 there was a continuing debate on several levels about whether or not Ketek (telithromycin) should be withdrawn from the market due to its alleged four-times increased risk of causing liver failure when compared to other antibiotics.

In a June 9, 2006 article in The Wall Street Journal, Anna Wilde Mathews reported:

… FDA drug-safety reviewers have linked the drug to 12 cases of liver failure, including four deaths. In a May 16 memorandum, the agency’s Division of Drug Risk Evaluation recommended a prominent new label warning that "severe, life-threatening and in some cases fatal" liver toxicity has been reported in patients taking Ketek.

A June 8, 2006 New York Times article by Gardiner Harris revealed that an internal May 2006 FDA memorandum stated that some staff members have serious concerns about the safety of Ketek:

There is growing evidence that Ketek is unusually toxic, according to a recent review by F.D.A. safety officials. Twelve adult patients in the United States have suffered liver failure, including four who died; 23 others suffered serious liver injury.

The safety officials wrote in their review that the agency should consider forcing Sanofi-Aventis to withdraw Ketek from the market, severely restrict its uses, even in adults, or add a prominent warning to its label about potentially fatal side effects….

In her memorandum, [FDA spokeswoman] Dr. Johann-Liang suggested that Ketek’s risks outweighed its benefits.

Meanwhile, Theresa Agovino, for The Associated Press, reported on June 8, 2006:

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.

FDA spokeswoman Susan Bro said the agency was not considering removing Ketek from the market but that it was conducting a review of the drug’s safety. She said the review would be completed shortly.

And, Reuters reported in their June 9, 2006 article about the Ketek drug-safety issue:

At the request of Europe’s drug regulator, Sanofi has already included stronger warnings about potential liver disorders on product information for Ketek.

Another allegedly unsafe drug, another decision; we wait to see what the FDA does on this one.

(Posted by: Tom Lamb)