Merck & Co., Inc. announced September 30th a voluntary withdrawal of Vioxx (chemical name rofecoxib) from the U.S. market due to safety concerns. Vioxx is a prescription COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) that was approved by the Food and Drug Administration (FDA) in May 1999 for the relief of the signs and symptoms of osteoarthritis, for the management of acute pain in adults, and for the treatment of menstrual symptoms. It is also approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children.

The FDA was informed by Merck & Co., Inc. on September 27, 2004, that the Data Safety Monitoring Board for an ongoing long-term study of Vioxx (APPROVe) had recommended that the study be stopped early for safety reasons. The study was being conducted in patients at risk for developing recurrent colon polyps. The study showed an increased risk of cardiovascular events (including heart attack and stroke) in patients on Vioxx compared to placebo, particularly those who had been taking the drug for longer than 18 months. Patients taking the drug chronically face twice the risk of a heart attack compared to patients receiving a placebo.

Based on this new safety information, Merck and FDA officials met the next day, September 28, 2004, and during that meeting the FDA was informed that Merck was voluntarily withdrawing Vioxx from the market place.

As far back as June 2000, Merck submitted to FDA a safety study called VIGOR (Vioxx Gastrointestinal Outcomes Research) that found an increased risk of serious cardiovascular events, including heart attacks and strokes, in patients taking Vioxx compared to patients taking naproxen. In April 2002, after reviewing the results of the VIGOR study and other available data from controlled clinical trials, FDA implemented labeling changes to reflect the findings from the VIGOR study. The labeling changes included information about the increase in risk of cardiovascular events, including heart attack and stroke. The drug remained on the market, however, and no action was taken by Merck & Co., Inc.

The Vioxx recall has the potential to create hundreds of thousands of Vioxx claims against Merck & Co., Inc. If you think you may have a Vioxx claim or have used Vioxx in the past and are unsure, call 877- VIOXX- SUIT to speak with a Vioxx attorney.