Vioxx & Side Effects

Vioxx is the brand name for a nonsteroidal anti-inflammatory drug manufactured by Merck. The generic name is rofecoxib, and it is also marketed as Ceoxx and Ceeoxx. Vioxx gained FDA approval in 1999 as a safe and effective drug, and it was prescribed to treat chronic and acute pain, osteoartheritis and dysmenorrhoea. In 2004, Merck voluntarily withdrew Vioxx from the market due to unexpected and dramatic negative side effects associated with long-term, high-dosage use, namely cardiovascular events like heart attack and stroke.

VIGOR Study

• A 2001 study known as VIGOR (Vioxx GI Outcomes Research) found that Vioxx patients were at significantly greater risk for heart attack and stroke than patients who took pain medications like naproxen; this difference appeared after about two months of starting the medication. Vioxx patients faced about four times the risk of heart attack as those on naproxen, but they did not face a significantly different mortality rate.

APPROVe Study

• In 2004, the APPROVe (Adenomatous Polyp PRevention On Vioxx) study suggested that patients on Vioxx were at higher risk of heart attack and stroke when compared to patients on placebos. Patients on Vioxx faced almost twice the risk of heart attack as patients on placebos. They did not have a higher mortality rate, however.

Other Studies

• Other studies conducted and funded by Merck found that Vioxx patients faced up to seven or eight times the risk for cardiovascular events than those placed on placebos.

FDA Conclusion

• FDA analysts concluded in 2004 that Vioxx had caused heart attack and stroke in many patients, and that up to 40 percent of those incidents were fatal. As a result, Merck voluntarily withdrew Vioxx from the market.

Further Studies

• A 2006 study from the "Journal of the American Medical Association" found an increased risk of renal disease and heart arrhythmia associated with taking Vioxx.