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Vioxx (rofecoxib) was introduced to the U.S. market in 1999, designed to block inflammation and pain caused by osteoarthritis, as well as for acute pain in adults and for the treatment of menstrual pain as effectively as drugs like aspirin and ibuprofen without the ulcer and gastrointestinal risks associated to the older treatments. Though worldwide sales of Vioxx reached $2.55 billion in 2003 alone, Vioxx sales have evened out in recent years after clinical trial data showed Vioxx increased the incidence of blood clots tied to strokes and heart attacks.
Now, a study has confirmed there is an increased risk for cardiovascular events, including heart attack and stroke starting 18 months after beginning Vioxx treatment when compared to those taking a placebo. The risk is considered so great that a Vioxx recall has been issued. The data safety monitoring board overseeing the long-term study of Vioxx recommended that the study be halted because of the increased risk of serious cardiovascular events. The FDA commended Vioxx manufacturer Merck & Co. for reporting the early findings to the FDA.
In June 2000, Merck submitted a safety study called Vioxx Gastrointestinal Outcomes Research (VIGOR) to the FDA after finding an increased risk of serious cardiovascular events, including heart attacks and strokes among patients taking Vioxx compared to patients taking naproxen. The FDA reviewed the study results and consulted with its Arthritis Advisory Committee in February 2001 regarding the clinical interpretation of the new safety information. In April 2002, the FDA implemented Vioxx labeling changes to include the findings of increased risk of cardiovascular events, including heart attack and stroke from the VIGOR study.
A recent study by the FDA suggested patients taking Vioxx have a 50 percent greater risk of heart attacks and sudden cardiac death than those taking Pfizer''s rival arthritis treatment Celebrex. Other studies have also suggested an increased risk of cardiovascular events to occur among Vioxx patients.
Ninety one million prescriptions have been written for Vioxx in the U.S. alone. Please contact a Vioxx Recall Lawyer to confer with a drug recall lawyer and to learn your legal rights and options regarding Vioxx side effects.