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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.