Vioxx

On September 30, 2004, Merck & Co., Inc. announced the withdrawal of its arthritis drug Vioxx from the U.S. and worldwide market due to safety concerns of an increased risk of heart attack and stroke. Other serious side effects include kidney insufficiency or failure, congestive heart failure, transient ischemic attacks, high blood pressure and peripheral edema. In 2003 Merck had $2.5 billion dollars of sales in Vioxx.

Vioxx, also known as Rofecoxib, is used to reduce pain from gastrointestinal problems, menstrual cramps, and arthritis. It is part of a class of nonsteroidal anti-inflammatory drugs (NSAIDs) called "COX-2 inhibitors." Currently, the only other drug in this class is the new arthritis medication called Celebrex.

When it first emerged in the late 1990's, Vioxx, was touted as being safer and more effective than readily available NSAIDs such as aspirin and ibuprofen. Like NSAIDs, Vioxx relieves pain and inflammation by inhibiting the effect of a natural enzyme called COX-2. Unlike the older medications, however, Vioxx does not interfere with a similar substance, called COX-1, which exerts a protective effect on the lining of the stomach. While Vioxx does not affect the lining of the stomach, a new research study indicates that using Vioxx may carry an increased risk of heart attack.

The research study sponsored by Merck, Vioxx’s manufacturer, last year showed that patients taking Vioxx had four times the risk of heart attacks than those taking aspirin or ibuprofen. The study also noted that the risk of heart attack increased over time. Although the heart risk is still low, the U.S. Food and Drug Administration is now considering adding warning labels to both Vioxx and Celebrex about cardiovascular side effects. Today, doctors are worried about the possibility of heart attacks because many arthritis patients taking Vioxx are elderly and have a higher risk of cardiovascular problems. Other side effect associated with Vioxx include, stroke, seizure, kidney and liver damage, pregnancy complications, birth defects, and high blood pressure.