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Vioxx Safety

Serious Vioxx safety concerns prompted Merck, the makers of this top selling prescription pain killer, to voluntarily withdrawal this drug from the market worldwide. These serious Vioxx safety concerns peaked after clinical trial evidence showed that patients taking Vioxx for at least eighteen months were two times more likely to suffer heart attack or stroke as compared to the general population. Vioxx safety concerns were expressed even prior to these clinical study findings, as patients began to suffer from a number of Vioxx side effects.

Vioxx is a COX-2 selective non-steroidal anti-inflammatory drug (NSAID) originally approved by the FDA in 1999. COX-2 selective NSAIDs, including Vioxx, Celebrex, and Bextra, were originally developed in the 1990s in hopes of creating a drug that was effective at treating pain but did not cause the gastrointestinal complications associated with traditional NSAIDs like ibuprofen and naproxen. Gastrointestinal Vioxx safety was claimed superior to the gastrointestinal safety of more traditional NSAIDs.

The VIGOR study was designed to compare the gastrointestinal Vioxx safety compared to the safety of naproxen, in hopes that these findings would confirm these Vioxx safety claims. The nine month VIGOR study did find that Vioxx users had a slightly lower risk of suffering gastrointestinal side effects as compared to naproxen users. However, Vioxx users did have a significant risk of suffering significant gastrointestinal side effects, especially if the patient had a history of gastrointestinal problems.

Cardiovascular Vioxx safety was also called into question after the results of the VIGOR trial were announced. VIGOR trial evidence showed that the risk of suffering a myocardial infarction- or heart attack- was four times greater for those patients taking Vioxx compared to naproxen users. The study also indicated that Vioxx users were twice as likely to suffer an adverse thrombotic cardiovascular event compared to naproxen patients. Vioxx safety was an even greater concern for patients with a history of heart problems who were five times more likely to suffer a heart attack or stroke.

In response to Vioxx safety concerns, Merck insisted that Vioxx didn't increase these risks, but that naproxen actually prevented these adverse events. This was disproved shortly thereafter, though no significant effort was made to increase cardiovascular Vioxx safety or reduce the risks posed to patients. In 2004, the results of the APPROVe study confirmed the results of the VIGOR trial. The APPROVe trial found that cardiovascular Vioxx risks were so great that they outweighed any possible benefit yielded from use of this drug. As a result of these serious Vioxx safety concerns, the drug was taken off the market.

Many experts argued that Merck and the FDA had knowledge of serious Vioxx risks years prior to the recall, but negligently chose to ignore these Vioxx safety warnings. Over 300 Vioxx lawsuits have been filed on behalf of Vioxx side effect victims. If you are interested in learning more about your rights and options in a Vioxx legal case, please contact us to confer with a qualified attorney in your area.

More Vioxx Resources

MedLine Plus Drug Information - Guide to prescription and over-the-counter medications provided by the United States Pharmacopeia.

Vioxx.com - Official Vioxx Roxecofib site from Merck.

Vioxx Drug Warnings - Vioxx side effects information including lawsuit information and vioxx warnings.

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