The large drug manufacturer Merck &. Co., Inc. announced on September 30, 2004 that it would withdraw VIOXX (rofecoxib), its arthritis and acute pain medication, from the market world-wide. According to the company's press release, it was a decision based on data from a randomized, placebo controlled clinical trial (the APPROVe trial) investigating whether VIOXX prevented the recurrence of colon polyps. That trial was stopped immediately because data showed that patients taking VIOXX had an increased risk for confirmed cardiovascular events, such as heart attack and stroke, beginning after 18 months of treatment.
VIOXX was launched in the United States in 1999 and has been marketed in more than 80 countries. In some countries, the product is marketed under the trademark CEOXX. Worldwide sales of VIOXX in 2003 were $2.5 billion.
This is not the first clinical trial to raise suspicion about VIOXX. Results from the VIGOR (VIOXX Gastrointestinal Outcomes Research) study, released in March 2000, also indicated an increased risk of cardiovascular events compared to another painkiller.
In September 2001, the United States Food and Drug Administration (FDA) issued a Warning Letter to Merck based on its conclusion that Merck had engaged in a misleading promotional campaign that minimized the potentially serious cardiovascular findings in the VIGOR trial and thus misrepresented the safety of VIOXX.
On September 30, 2004, FDA issued a Public Advisory to inform patients of Merck's actions and to advise them to see their doctors for alternative medications.
If you or your loved one has taken VIOXX and suffered a heart attack or stroke, you may want more information. Please feel free to contact Bruce Finzen or Tara Sutton or to send them an e-mail click on this link: contact us.
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