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Merck Vioxx is a once-top selling prescription pain reliever that was pulled from the shelves in September 2003. The recall of Merck Vioxx was prompted by clinical findings concluding that Vioxx users were twice as likely to suffer a stroke or heart attack as the general population. Merck Vioxx is the first COX-2 non-steroidal anti-inflammatory drug (NSAID) to be recalled as a result of its significant cardiovascular dangers. Bextra, a similar drug, was also pulled due to its serious potential side effects. Celebrex is currently under investigation and has also been associated with cardiovascular side effects.
Merck Vioxx was first approved by the FDA in 1999 as a safe and effective treatment for chronic pain conditions such as rheumatoid arthritis, osteoarthritis, and severe menstrual cramping. Due to Merck's aggressive marketing of Vioxx, the drug rapidly became the most popular prescription pain killer on the market. Due to its alleged safety and effectiveness, doctors across the nation prescribed Merck Vioxx to millions of consumers prior to the recall of this defective drug.
In 2001, the results of the Merck-sponsored clinical trial, VIGOR, were released. These findings were the first publicly available information indicating the potential risk of serious cardiovascular side effects associated with Merck Vioxx. The study was designed to compare the gastrointestinal side effects of Vioxx and naproxen, a traditional NSAID. The results indicated that those in the Vioxx group were two to five times more likely to suffer a serious thrombotic cardiovascular adverse event.
Despite this evidence of serious cardiovascular side effects, Merck did not take any action to investigate the risks further or warn the public about the potential side effects posed by their painkiller. The FDA even sent a letter to Merck stating the company's promotional activities and materials for Vioxx, "are false, lacking in balance, or otherwise misleading in violation of federal law." The 2001 letter also charges Merck with minimizing the potentially serious cardiovascular findings of the VIGOR study, omitting important risk information, making unsubstantiated superiority claims against other NSAIDs, and more.
Merck Vioxx remained on the market, virtually unscathed for another two years, despite significant findings that would suggest the drug was defective and dangerous. The company sponsored another clinical trial, APPROVe, which was designed to measure the effect of Merck Vioxx on colon polyps. The study was cut short after researchers again found a significant risk of cardiovascular side effects associated with Vioxx. This study concluded that patients taking Merck Vioxx are two times more likely to suffer a serious stroke or heart attack, compared to the general population. This information could not be ignored by Merck any longer and they finally pulled Vioxx of the market.
Since the recall, more than seven thousand patients injured by Merck Vioxx have come forward to seek relief for their losses and suffering. If you would like to learn more about Merck Vioxx, please contact us to speak with a qualified and experienced attorney.
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.