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

Paul E Langton, Graeme J Hankey and John W Eikelboom
Med J Aust 2004; 181 (10): . || doi: 10.5694/j.1326-5377.2004.tb06433.x
Published online: 15 November 2004

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

  • Paul E Langton1
  • Graeme J Hankey2
  • John W Eikelboom3

  • 1 Hollywood Private Hospital, Perth, WA.
  • 2 Royal Perth Hospital, Perth, WA.


Competing interests:

Dr Langton has given advice to and/or talks for a variety of pharmaceutical companies, including Pfizer and Merck Sharp & Dohme.


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