Vioxx, a widely used prescription medicine produced by drug manufacturing giant, Merck & Co., was voluntarily withdrawn on September 30, 2004 due to mounting evidence linking it to increased risk of cardiovascular problems. Following a three-year study involving the drug, it was concluded that withdrawing Vioxx from the market would be in the best interest of the patients. The drug, a popular pain reliever used worldwide by millions of patients, has also been connected with higher incidences of respiratory and liver and kidney dysfunction.

The removal of Vioxx from the market was a major surprise to many people but the first signs of problems with Vioxx were first noticed over four years ago. In fact even before Vioxx was approved by the FDA a University of Pennsylvania study raised questions about whether Vioxx increased the risk of heart attacks and strokes.

Merck's voluntary withdrawal of Vioxx from the market has started a firestorm of probing inquires. Some analysts and cardiologists are criticizing the FDA for not acting faster as the evidence mounted over 5 years, pointing to an increased risk of heart attacks and strokes with Vioxx. Others are defending the FDA, claiming it is hard to associate conditions which are so widespread with a particular drug.

Shortly after Vioxx was approved and put on the market a study sponsored by Merck and published in the New England Journal of Medicine in 2000 clearly showed an increase in heart attacks. In 2001 Doctors at the Cleveland Clinic published a study in the Journal of American Medical Association JAMA re-analyzing existing data. This study again showed the risk of heart attacks and other serious side effects. Instead of acknowledging Vioxx's side effects Merck said it would conduct a big study testing Vioxx's heart safety, but the study never materialized.

By the time Vioxx was removed from the market it had been used by millions of people worldwide and its annual sales in 2003 totaled $2.5 billion. On September 30, 2004 Vioxx was finally taken off the market. The withdrawal came after a Merck study that tried to show Vioxx reduced Colorectalpolyps, instead showed again that Vioxx increased the risk of heart attacks, strokes, blood clots and other cardiovascular injuries.