FDA Schedules Outside Panel Review Of Sanofi Aventis' Antibiotic Ketek Amid Reports Of Liver Failure

Following on the heels of reports of liver failure for persons using the Sanofi Aventis antibiotic Ketek, the FDA has convened an independent panel of experts to review the medication's safety.

(PRWEB) November 19, 2006 -- Rosenbaum Faria, LLP, a Manhattan lawfirm has confirmed that the US FDA has scheduled a December 14 and 15 meeting of an outside expert panel to review the safety of Sanofi Aventis' antibiotic Ketek (telithromycin).

The experts are to "discuss the overall benefit to risk considerations" for Ketek, an FDA spokesperson said in a notice announcing the meeting as reported by Reuters. The antibiotic is currently approved to treat acute bacterial infections of chronic bronchitis, bacterial sinusitis, and community-acquired pneumonia.

Senate Finance Committee Chairman, Senator Chuck Grassley, has repeatedly requested documents and studies from the FDA relative to the safety of Ketek beginning in 2004. Specifically, the Committee wants to see the pediatric studies that were being conducted on children from six months to 13 years. Senator Grassley has requested that the FDA advise what action was being taken to fully inform the parents enrolled in the study about the risks and benefits of Ketek. According to Senator Grassley's website, the FDA has not provided a reasonable response to the Committee's multiple requests.

Said Cory Rosenbaum, a partner in the firm, "The outside panel of experts is a definite step forward in protecting the public. Deaths and liver problems in otherwise healthy people given Ketek could have been prevented before. The Senate Committee already knows that Sanofi's Study 3014 was fraudulent."

"Hopefully, the December panel will do more than the last panel. Back in April 2001, the Anti-Effective Drugs Advisory Committee, was told to consider whether Ketek's benefits outweighed its risks. That panel recommended that Aventis conduct a large clinical safety study, but the FDA told Aventis to just conduct a safety study," said Sol Kodsi, another partner in the firm.

"Sanofi Aventis first asked the FDA to approve Ketek in 2000, but the FDA refused. Aventis conducted a study of 24,000, submitted it to the FDA, and got their approval. The FDA knows the study is fraudulent. This is unconscionable on the part of Sanofi Aventis and the FDA," said Rosenbaum.

Rosenbaum Faria, LLP will continue to monitor the progress of the independent expert panel and the risks of Ketek. All updated information will be posted to their website at www.rosenbaumfaria.com.

http://www.fda.gov/fdac/departs/2004/404_upd.html#fraud
http://www.fda.gov/cder/drug/advisory/telithromycin.htm
http://www.clinicaltrials.gov/ct/show/NCT00315003?order=2
Reuters: USA FDA to Seek Outside Review of Sanofi Antibiotic, 11/14/06, 5:01PM

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