Vioxx® is in a class of medications called selective cyclooxygenase-2 inhibitors (COX-2 inhibitors). In other words, they are a specialized form of non-steroidal anti-inflammatory drug (NSAID). NSAIDs and COX-2 inhibitors are used for treatment of osteoarthritis, rheumatoid arthritis, and other indications requiring pain relief. These drugs are available under the names Vioxx®, Bextra®, and Celebrex®. Recently, Vioxx® and Bextra® have been pulled from the market in the United States. These specialized anti-inflammatory agents were developed to avoid some of the negative side-effects of normal NSAIDs while retaining the desired benefits. Some of the side-effects that COX-2 inhibitors reduce include: upset stomach, ulcers, and gastrointestinal bleeding. A few of the benefits COX-2 inhibitors are said to provide include: decrease in colon cancer (polyps), control of pain due to arthritis, and even pain relief due to menstruation.

Cyclooxygenase (COX) is an enzyme that helps build certain inflammatory factors like prostaglandins that mediate pain. Some of the factors produced are also responsible for normal repair and maintenance of cells, particularly in the stomach and intestines. We have discovered two different pathways regulated by two different COX enzymes. They have been designated COX-1 and COX-2. The COX-2 inhibitors act by blocking only the pathway that causes pain and inflammation. The COX-1 pathway is responsible for rebuilding and normal maintenance of body tissue. However, some people believe by blocking one pathway, the other pathway is flooded and this flooding overcomes the beneficial effects.

Recently, the news has reported COX-2 inhibitors as a cause of increased risk for cardiac events or heart attacks. The safety of these drugs has recently been in question. Vioxx® was the first drug voluntarily pulled off the market because of these findings. As of April 8, 2005, Bextra®, which is another COX-2 inhibitor, was also removed from the market. It was removed because taking the drug placed patients at an increased risk for a serious skin reaction (Stevens-Johnson syndrome). However, the FDA recommended the drug be voluntarily suspended due to the same adverse cardiac events associated with Vioxx®. Healthcare providers are still debating whether or not there is a true risk. Overall, the results are inconclusive; however, studies have shown a significant risk for cardiac events in certain populations. There is currently not enough evidence to show the COX-2 inhibitors cause cardiac events alone, but we are becoming aware of their ability to increase risk in a susceptible population. In other words, if you have had heart problems in the past, have a history of high blood pressure, have diabetes, or other risks determined by your health-care provider, the benefits of a COX-2 should be strongly evaluated. The FDA and NIH feel anyone taking Vioxx® or Bextra® may be at increased risk for cardiovascular events including heart attack, cardiovascular accidents, stroke, and even death. Unless a patient has a greater chance of gastrointestinal bleeding, it may be a good idea to choose an older generation NSAID such as ibuprofen or naproxen to treat arthritis before you reach for a COX-2 inhibitor. If you and your healthcare provider choose to continue with Celebrex® therapy, the FDA currently recommends using the lowest effective dose for the shortest possible treatment duration.

Reference: http://www.fda.gov/bbs/topics/news/2005/NEW01171.html

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