Cardiovascular safety of rofecoxib (Vioxx): lessons learned and unanswered questions

We need processes in place to follow up suspicions about serious adverse events

Rofecoxib and a second cyclooxygenase-2 (COX-2) inhibitor, celecoxib, were approved by the Therapeutic Goods Administration in 1999 after large phase III randomised trials showed they were as effective as “traditional” non-steroidal anti-inflammatory drugs in reducing pain and inflammation and less likely to cause gastric ulceration.1,2 Since then, COX-2 inhibitors have become one of the 10 most widely used prescription medicines in Australia, at a cost to the federal government of more than $200 million annually.3 However, uncertainty has surrounded the cardiovascular safety of rofecoxib (Vioxx; Merck Sharp & Dohme), and COX-2 inhibitors as a class, ever since an increased risk of cardiovascular events was reported among patients randomly allocated to the rofecoxib group in the VIGOR trial.1