What Is Vioxx?

Wikipedia wrote:

Vioxx (also known as Rofecoxib) belongs to a class of pain relievers called non-steroidal anti-inflammatory drugs or NSAIDS... that work by inhibiting cyclooxygenase (COX), an enzyme that stimulates the synthesis of prostaglandins, chemicals in the body that promote inflammation and pain.

While traditional NSAIDS have long been a mainstay of treatment for patients needing pain relief, this relief does not come without significant adverse side effects—namely a great increase in the risk of gastrointestinal perforations, ulcers, and bleeds or PUBs. Scientists have estimated that NSAID-induced PUBs have caused more than 16,500 deaths and 100,000 hospitalizations annually in the United States. (Wolfe, MM et al, 1999)

Several very large observational studies have also found elevated risk of heart attack from rofecoxib. For example, a recent retrospective study of 113,000 elderly Canadians suggested a borderline statistically significant increased relative risk of heart attacks of 1.24 from Vioxx usage, with a relative risk of 1.73 for higher-dose Vioxx usage. (Levesque, 2005). Another study, using Kaiser Permanente data, found a 1.47 relative risk for low-dose Vioxx usage and 3.58 for high-dose Vioxx usage compared to current use of celecoxib, though the smaller number was not statistically significant, and relative risk compared to other populations was not statistically significant. (Graham, 2005).

Furthermore, a more recent study of 114 randomized trial comprised of 116,000+ participants, published in JAMA, showed that Vioxx uniqued increased risk of renal (kidney) disease, and heart arrhythmia.

Merck publicly announced its voluntary withdrawal of the drug from the market worldwide on September 30, 2004.

In addition to its own studies, on September 23, 2004 Merck apparently received information about new research by the FDA that supported previous findings of increased risk of heart attack among rofecoxib users (Grassley, 2004). FDA analysts estimated that Vioxx caused between 88,000 and 139,000 heart attacks, 30 to 40 percent of which were probably fatal, in the five years the drug was on the market.

On November 5 the medical journal The Lancet published a meta-analysis of the available studies on the safety of rofecoxib (Jüni et al., 2004). The authors concluded that, owing to the known cardiovascular risk, rofecoxib should have been withdrawn several years earlier. The Lancet published an editorial which condemned both Merck and the FDA for the continued availability of rofecoxib from 2000 until the recall. Merck responded by issuing a rebuttal of the Jüni et al. meta-analysis that noted that Juni omitted several studies that showed no increased cardiovascular risk. (Merck & Co., 2004).

In 2005, advisory panels in both the U.S. and Canada encouraged the return of rofecoxib to the market, stating that rofecoxib's benefits outweighed the risks for some patients. The FDA advisory panel voted 17-15 to allow the drug to return to the market despite being found to increase heart risk. The vote in Canada was 12-1, and the Canadian panel noted that the cardiovascular risks from rofecoxib seemed to be no worse than those from ibuprofen[11] — though the panel recommended that further study was needed for all NSAIDs to fully understand their risk profiles. Notwithstanding these recommendations, Merck has not returned rofecoxib to the market.