FDA criticizes Aventis for Ketek study failures

Thu, 25 Oct 2007 06:59:57 -0400

Aventis allowed a clinical trial of Ketek to proceed uncorrected despite its own audits that revealed "serious protocol violations and regulatory noncompliance by multiple clinical investigators." In a letter to Sanofi-Aventis, regulators severely criticized Aventis for not throwing doctors out of the study or informing the FDA. The FDA approved Ketek back in 2004. Ketek has since been linked to an increased risk of liver damage, and the questionable study was designed to investigate the drug's potential side effects, including liver damage. One doctor responsible for one site involved in the study was subsequently convicted of fraud. Sanofi-Aventis says the company acted in good faith and plans a detailed response, but that's hardly likely to mollify the company's critics.

- see the FDA release
- here's the article from The Wall Street Journal

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Baraclude given Black Box Warning

Fri, 17 Aug 2007 06:59:55 -0400

The FDA has put a Black Box Warning on Bristol-Myers Squibb's hepatitis B drug Baraclude. A warning letter to doctors said that Baraclude should not be given to HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy because of potential for the development of HIV resistance. BMS recommends that HIV testing should be conducted in all hepatitis B virus patients before starting treatment with Baraclude.

- check out the release on the label change

Related Article:
Baraclude approved for hep B. Report

FDA warning

FDA criticizes Aventis for Ketek study failures

Baraclude given Black Box Warning