In September 2004 Merck announced the withdrawal of the popular anti-inflammatory drug Vioxx from the market due to a study that showed patients taking the drug faced twice the risk of heart attack and stroke. Since then, the safety of non-steroidal anti-inflammatory drugs (NSAIDs) has been reevaluated and Pfizer's Bextra, an NSAID known as a COX-2 inhibitor, has suffered the consequences.
The Food and Drug Administration (FDA) announced that Pfizer has agreed to stop selling Bextra due to the risk of rare but life-threatening skin reactions. Of all the anti-inflammatory pain relievers, Bextra was most frequently sourced in reports of skin reactions.
New "Black-Box" Warning for Anti-Inflammatory Pain Relievers
The FDA will require a "black-box" warning--the strongest warning possible--to be placed on the labels of Pfizer's blockbuster arthritis drug Celebrex, and other, older prescription anti-inflammatory pain relievers such as ibuprofen and naproxen. The warning will specifically caution against possible cardiovascular and gastrointestinal risks including:
Pain relievers that can be purchased over the counter will also include similar information on their labels, as well as a warning regarding potentially fatal skin reactions. (The wording of the warnings will differ depending on whether the drug is sold by prescription or over the counter.)
Pfizer advises patients, for the time being, to resist using Bextra and to contact their doctors about appropriate treatment options.
USA Today April 7, 2005
Could it be that the FDA is finally coming to its senses? It's not likely, as each positive decision they make seems to be preceded, or followed, by an equally ridiculous one. Regardless, credit must be given where it is due, and the FDA deserves at least a little of it here. Pulling a nasty drug like Bextra off the market is a major step in the right direction, as is requiring black-box warnings on all other NSAIDS (although, so far, the latter hasn't officially happened yet).
Bextra is particularly toxic and, like I said four years ago, we should have never trusted its manufacturer's word on its safety in the first place. We can only hope that the same unfortunate set of circumstances surrounding the return of Vioxx to the market does not repeat itself here and result in Bextra coming back to the market as well.
Perhaps the most important part of the FDA's recent decision involves the inclusion of over-the-counter drugs like Aleve, aspirin and ibuprofen in their list of NSAIDS requiring more revealing warning labels. With all the recent press involving the more expensive prescription NSAIDS, it's easy to forget that drugs like Aleve or ibuprofen also have potentially deadly side effects. If you listen to the radio or watch television, you have probably heard one of the many new ads for these drugs. Their makers have been trying to convince you that they are a safer alternative to Vioxx, Celebrex and the other COX-2 inhibitors that have gotten so much press lately, when you're really just playing a game of "pick your poison."
Fortunately, there are a number of very effective alternative anti-inflammatory treatments that work just as well as NSAIDS but whose primary side effect is improving your health. Products such as:
... can be used not only to reduce inflammation, but also to PREVENT the very same cardiovascular conditions that NSAIDS can cause!
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