Friday, April 22, 2005

Bextra's withdrawal: the FDA's reasoning is a MUST READ

Why did the FDA do it? A nineteen page memo gives answers. You can find it here.

The document was written by John Jenkins, the director of the Office of New Drugs, and Paul Seligman the director of the office that handles statistical science and epidemiology. It states the reasons for the Bextra recall. The memo states that Vioxx, Bextra and Celebrex all appear to be linked to an increased risk of heart attack and stroke.

Our office is investigating these claims. If your office is also doing so, it's worth the time to read this important analysis.