February 19, 2005

FDA's odd, questionable deliberation of Vioxx et al

The FDA advisory panel that looked at the safety of Cox-2 inhibitors and walked away with a mealy-mouthed, back-door endorsement of this class of drugs -- in the face of strong evidence of risks -- is troubling.

Journalist Merrill Goozner writes about the label you won’t read on Celebrex, Bextra and Vioxx (if Merck decides to bring Vioxx back):

"WARNING: This drug increases your risk of a heart attack or stroke. This drug provides no more pain relief than generic and over-the-counter painkillers. There is no reason to take this expensive, prescription drug unless you are among the 1 to 4 percent of people who suffer from gastrointestinal side effects from other
painkillers, which are available at one-tenth the price at your local supermarket or drug store without a prescription. Nearly half of all heart attacks are fatal and those who survive must deal with the consequences for the rest of their lives. Only one in 20 ulcers are fatal and the vast majority of gastrointestinal problems are easily treated with few long-term effects."

Posted by schwitz at February 19, 2005 12:02 PM
Comments
The views and opinions expressed in this page are strictly those of the page author. The contents of this page have not been reviewed or approved by the University of Minnesota.