Who Is On Your Side?

Halt Is Urged for Trials of Antibiotic in Children
By GARDINER HARRIS

A Food and Drug Administration official called in May for a drug company to halt clinical trials of an antibiotic in children because the drug could be deadly, according to internal memorandums sent to other F.D.A. officials.

The drug, Ketek, made by Sanofi-Aventis, is being tested as a treatment for ear infections and tonsillitis in nearly 4,000 infants and children in more than a dozen countries, including the United States, according to postings on a government Web site. But Ketek, which is currently approved for use only in adults, has been reported to cause liver failure, blurred vision and loss of consciousness in adults.

"How does one justify balancing the risk of fatal liver failure against one day less of ear pain?" Dr. Rosemary Johann-Liang, an official in the Office of Drug Safety at the agency, wrote in one of the memorandums, a copy of which was obtained by The New York Times.

Sanofi-Aventis is sponsoring four clinical trials in children ages 6 months to 13 years, according the Web site posting. The drug agency approved plans for the trials.

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.

More than five million prescriptions for Ketek have been written in the United States since its approval two years ago.

Asked about the memorandum written by Dr. Johann-Liang, an F.D.A. spokeswoman, Susan Bro, said that it was "a preliminary, raw assessment" and that "the final decision will be made by experts who have the full benefit of a large section of opinion and scientific fact."

Melissa Feltmann, a spokeswoman for Sanofi-Aventis, said in an e-mail message, "We are engaged in ongoing discussions with the F.D.A. regarding Ketek."

Other antibiotics cause liver failure, but Ketek seems to do so almost four times as often, the safety officials concluded in the review.

With this fatality rate in adults, what the fuck were they thinking about even trying this in kids? Isn't it nice to know your government is looking out for you?

Posted by Melanie at June 8, 2006 09:52 AM | TrackBack