FDA Says Sanofi-Aventis Failed To Halt Serious Abuses In Study Of High-Risk Ketek

-TradingMarkets.com

10/26/2007 -  Government investigators have said that Sanofi-Aventis ignored misconduct by doctors who helped test the high-risk antibiotic Ketek, that was later linked to several deaths.

Congress has been investigating FDA's approval of the drug since last year after several users developed serious liver problems and died. Earlier this year, the agency limited the use of Ketek, which was approved in 2004 to treat bronchitis, sinus infections and pneumonia, saying it should be used for pneumonia only, not less serious illnesses.

The government said one physician who worked on the study falsified data, including fabricating a patient's existence. Even after raising concerns about the researcher with Sanofi, government investigators said the company did not discipline or fire the physician. The physician was sentenced to 57 months in prison after pleading guilty to fabricating the patient's identity.

The FDA also said Sanofi failed to check the credentials of physicians who participated in the study. Shares of Sanofi-Aventis rose 42 cents, or one percent, to close at $42.63.

If you or a loved one have experienced liver damage, liver failure, or Stevens Johnson Syndrome as a result of Ketek side effects contact the Ketek attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and attorneys are standing by to answer any questions you may have regarding Ketek side effects, a possible Ketek class action lawsuit, or any other type of Ketek litigation.