Merck recalled its Vioxx painkiller in 2004 after evidence showed increased cardiovascular risks.
Vioxx, known generically as rofecoxib, was a selective COX-2 inhibitor introduced in 1999 for pain and inflammation. Merck voluntarily withdrew it worldwide after a clinical trial found that patients taking the drug had a higher risk of heart attack and stroke over time.
The key study was the APPROVe trial, which examined Vioxx for prevention of colorectal polyps. The trial was stopped early when the cardiovascular risk became clear. Regulators and researchers then revisited earlier evidence about the medicine’s safety.
Vioxx’s withdrawal became a landmark pharmaceutical-safety case. It is sometimes described as a recall of a defective batch, but the action involved withdrawal of the entire marketed medicine because of an identified risk-benefit problem.