Merck recalled Vioxx in 2004 after studies found increased cardiovascular risk.
Vioxx was the brand name for rofecoxib, a selective COX-2 inhibitor used to treat pain and inflammation. Merck withdrew it worldwide on September 30, 2004, after the APPROVe clinical trial found an increased risk of heart attack and stroke with longer-term use.
The withdrawal was one of the largest pharmaceutical recalls in history and had major consequences for Merck, patients, regulators, and the design of drug-safety monitoring. Vioxx had been approved in the United States in 1999 and became a widely used prescription painkiller.
The recall concerned rofecoxib’s cardiovascular safety profile, not a contamination problem or a manufacturing defect. Vioxx is also commonly confused with celecoxib, another COX-2 inhibitor that remained on the market under the brand name Celebrex.