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Vioxx (rofecoxib), but not Celebrex (celecoxib), Significantly Increases the Risk of Heart Attack

Update Posted October 8, 2004

Since this information was posted on ClotCare, Vioxx has been pulled from the market and two leading authorities have published papers suggesting that the increased incidence of heart attack and stroke that resulted in the withdrawal of rofecoxib (Vioxx) is likely a class effect and occurs with celecoxib (Celebrex) and other COX 2 inhibitors. Links to these postings are below:

Merck Pulls Vioxx Due to Heart Attack and Stroke Risk
Stroke and Heart Attack: A Class Effect of COX 2 Inhibitors?

Henry I. Bussey, Pharm.D., FCCP, FAHA
May 2004

Review: Solomon DH, Schneeweiss S, Glynn RJ, Kiyota Y, Levin R, Mogun H, Avorn J. Relationship Between Selective Cyclooxygenase-2 Inhibitors and Acute Myocardial Infarction in Older Adults. Circulation. 2004 May 4;109(17):2068-2073. Epub 2004 Apr 19.

Aspirin is a Non-steroidal anti-inflammatory drug, (NSAID) which is used to reduce the risk of heart attacks. The beneficial effects of aspirin are thought to be due to the drugs ability to inhibit the role of certain blood cells (called platelets) in the formation of blood clots. The anti-inflammatory effects may also play a role. Aspirin and older NSAIDs, however, can promote stomach ulcers and increase bleeding risk. Newer drugs in this class have been designed to be more selective in how they work in order to reduce the risk of stomach ulcers and bleeding. These new agents, called cox-2 inhibitors, are thought to have less risk of stomach ulceration and bleeding, but there have been conflicting reports as to whether these newer agents may actually increase the risk of heart attacks.

In a study just published in the journal Circulation, investigators from Brigham and Women's Hospital at Harvard Medical School in Boston, Massachusetts reviewed data on 10,895 heart attacks that occurred in 54,475 patients 65 years of age or older. The use of Vioxx was associated with a 24% increase in the risk of heart attack when compared to Celebrex (statistical p value=0.011) and a 14% increase when compared to no NSAID (statistical p value=0.054). Further, the heart attack risk increased at higher doses (70% increase in heart attack risk at Vioxx doses > 25mg daily). The increased risk of heart attack with Vioxx was evident within the first 30 days of Vioxx therapy and over 30 to 90 days of therapy. After 90 days of Vioxx therapy, however, there was no increased risk of heart attack with Vioxx (or with Celebrex).

The study was supported by an unrestricted grant from Merck & Co. The authors had sole responsibility for the design, analysis, and publication of the results of the study.

Free access to the abstract of this article is available at

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Friday, June 21, 2024