Back to articles

COX-2 Inhibitors Under Scrutiny in Wake of Rofecoxib Withdrawal


In what is likely the largest drug recall ever in terms of sales, Merck announced on September 30 a worldwide, voluntary withdrawal of Vioxx, its brand of rofecoxib. The action was prompted by compelling results from a colon polyp prevention study that showed an increased risk of myocardial infarction (MI) and stroke associated with use of the drug, which last year accounted for $2.5 billion of Merck’s sales. All agents in this class—including some investigational agents that had appeared promising from an effectiveness standpoint—are now under intense scrutiny, but Pfizer is initiating a study of celecoxib (Celebrex) that the company believes could show a cardioprotective effect of this agent, which is less selective than other drugs in this category.


Solomon DH et al. Relationship between selective cyclooxygenase-2 inhibitors and acute myocardial infarction in older adults Circulation. 2004;109:2068–73.

Mamdani M et al. Cyclo-oxygenase-2 inhibitors versus non-selective non-steroidal anti-inflammatory drugs and congestive heart failure outcomes in elderly patients: a population-based cohort study. Lancet. 2004;363:1751–6.

FitzGerald GA. Coxibs and cardiovascular disease [perspective]. N Engl J Med. 2004;351:1709–11.

Topol EJ, Falk GW. A coxib a day won’t keep the doctor away [editorial]. Lancet. 2004;364:639–40.

Topol EJ. Failing the public health-rofecoxib, Merck, and the FDA [perspective]. N Engl J Med. 2004;351:1707–9.