Vioxx Recall Information

On September 30, 2004 the Food and Drug Administration (FDA) announced the voluntary recall of Vioxx (chemical name rofecoxib). Vioxx is an anti-inflammatory drug manufactured by Merck, & Co. The FDA also issue a public health advisory advising Vioxx users to consult with a physician about alternate medications.

Merck withdrew Vioxx after a long term study was cancelled due to an increased risk of serious cardiovascular problems including heart attacks and strokes.

The study suggested that patients taking Vioxx chronically face twice the risk of a heart attack compared to patients who were given a placebo.

Other drugs in this class are being closely monitored. According to Acting FDA Commissioner Dr. Lester M. Crawford "All of the NSAID drugs have risks when taken chronically, especially of gastrointestinal bleeding, but also liver and kidney toxicity..."

Vioxx was approved by the FDA in 1999 for the reduction of pain and inflammation caused by osteoarthritis and rheumatoid arthritis  as well other acute adult pains and for the treatment of menstrual pain.

In June 2000, Merck submitted a safety study 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, FDA implemented labeling changes to reflect the findings of this study. These labeling changes included information about the increased risk of cardiovascular events, including stroke and heart attack.

The FDA is working closely with Merck on arranging the removal of this product from the U.S. market.

For additional information visit: www.fda.gov/cder/drug/infopage/vioxx/vioxxQA.htm

If you are taking Vioxx and have suffered from heart attack, stroke, or other related symptoms please contact us for a free legal consultation.
 

Law Offices of John D. Winer