The Vioxx Story

Vioxx along with the other Cox-2 inhibitors (Celebrex, Bextra, and Mobic) were heralded as a major breakthrough in the treatment of arthritis. Prior to these drugs, most people turned to NSAIDS (non-steroidal anti-inflammatory drugs) like Motrin and Aleve. These drugs block both the Cox-2 and the Cox-1 enzymes in an attempt to decrease inflammation and improve the sympto

That didn't appear to be the case with Vioxx. The Cox-2 inhibitors primarily blocked only the Cox-2 enzymes and left the Cox-1 enzymes alone. As a result, they were initially shown to significantly decrease the risk of bleeding from the stomach. These newer Cox-2 inhibitors took the marketplace by storm and quickly became the most prescribed arthritis drugs in the world. An estimated 80 million people had taken Vioxx by the time it was withdrawn. Annual sales of the drug exceeded $2.5 billion. But shortly after Vioxx was released, a major study was reported in the Journal of the American Medical Association (2001). Serious evidence was mounting that the patients who were taking Vioxx had a significantly greater risk of having a heart attack or a stroke.1 The evidence continued to grow, but the slowness of the post-marketing surveillance division of the FDA kept the truth from getting out quickly, and of course Vioxx was unwilling to place stronger warnings on its product. As the system faltered, millions continued to take the drug in good faith, too often learning the dangers the hard way. In the end, Dr. Graham, a senior official of the FDA's Office of Drug Safety, estimated that since the introduction of Vioxx into the market in 1999, it has been responsible for an estimated 88,000 to 140,000 excess cases of heart attacks and strokes, many of which were fatal. We know the problem now. If only the Cox-2 enzyme is blocked, there quickly becomes an imbalance in the body between the Cox-2 and Cox-1 enzymes. This leads to an increase in the level of other inflammatory products called 1 Mukherjee D, Nissen SE, Topol EJ. "Risk of cardiovascular events associated with selective Cox-2 inhibitors. JAMA 2001:286:954-959 thromboxane A2. These cause increased clotting due to abnormal platelet aggregation which can cause a heart attack or stroke. Other side effects cause increased hardening of the arteries which, in turn, contributes to coronary artery disease. Even the decrease in stomach bleeding has been called into question with the Cox-2 inhibitors... But we didn't know any of that until they tested it on you.

Dr. David Graham testified during the Congressional hearings that the FDA's failure to protect the public health in the case of Vioxx was "a profound regulatory failure." In the October 21, 2004 New England Journal of Medicine, Dr. Topol wrote a very strong editorial criticizing the FDA's role in never mandating a post-market trial of Vioxx and similar Cox-2 inhibitors. Vioxx was never tested, after its release, to see if it really was a serious risk for heart attacks and strokes in spite of the mounting medical evidence that this was happening. Rather than fund a study, Merck had spent millions of dollars trying to convince physicians and the public that these concerns had absolutely no validity.

What to Do

Every drug has an inherent risk of producing adverse drug reactions. Drugs create a pharmacological effect by blocking certain normal enzymatic reaction or reactions to create a desired result. In the case of NSAIDS and Cox-2 inhibitors the result is decreased inflammation in the joints. However, these same enzymatic reactions are necessary for other beneficial functions in the body. When they are blocked, it can lead to very undesirable effects. In the case of NSAIDS, it can lead to stomach bleeding. In the case of Vioxx, it can lead to an increased risk of heart attacks or strokes.

Finally, it was determined that risks involved in taking Vioxx were greater than the benefits. Therefore Merck removed Vioxx from the market worldwide on September 30, 2004. Celebrex, Bextra, and Mobic are now under increased scrutiny because they potentially could have the same problems as Vioxx. Again, thousands may die taking these drugs for an illness that is never life threatening.

At this point, the medical community is encouraging everyone to switch to other arthritis medications which are in the NSAID class. At least, we know that the main problem they have is upper GI bleeding. If you have to take Celebrex, Bextra or Mobic, It is strongly recommended that you ask your doctor if you could take a low dose aspirin (81 mg daily) along with it. This can at least possibly reduce the increased risk of a heart attack and stroke as further studies are finally being done to determine the safety of these other Cox-2 inhibitors.

In my next article a we will discuss the natural remedies that are available today which can improve your arthritis. These remedies have no side effects and require only a little bit of faith to try.

Kevin McNabb http://tinyurl.com/38eoo7

How to start taking responsibility for your own health. Find out what true optimal health really means. http://tinyurl.com/38eoo7 This article is available for reprint, with the resource box intact. You can make money with this article by adding PPC ads to this article, so that you will generate revenue from the click-thru's. Please see additional articles from Kevin McNabb at http://globalhealthmgmt.blogspot.com/

About the Author

Focused on opening the communication channel between the medical community, the nutritional industry and the general public.

Dedicated to helping people around the world find financial freedom and prosperity.