VIGOR Study and COX-2 Side Effects
This page describes the VIGOR study and the side effects provided by COX-2 pain reliever drugs, focusing on the drug Vioxx. The safety of Vioxx has been questioned since the VIGOR study results became available in March 2000.
Merck initiated and funded the Vioxx Gastrointestinal Outcomes Research (VIGOR) to compare the gastrointestinal and other adverse side effects of Vioxx, a COX-2 inhibitor, to those of naproxen (Aleve), a traditional type of pain reliever that blocks both COX-2 and COX-1 enzymes equally.
A total of 8076 patients with rheumatoid arthritis were studied. VIGOR did not allow participants who were at high risk of heart problems. Patients could not take aspirin.
The study found that Vioxx patients showed fewer stomach problems. However, VIGOR also revealed a shocking fact: Those taking Vioxx had four times as many heart attacks (myocardial infarctions) as did the group taking naproxen. The FDA figures show it was a five-fold increase.
However, rather than recognizing the potentially life threatening cardiovascular side effects of Vioxx, the authors of the study concluded that the increased rate of heart attacks in patients taking Vioxx was due to the cardioprotective effect of naproxen. Moreover, VIGOR report stated there was "no difference in the incidence of cardiovascular events" between Vioxx and a placebo or between Vioxx and traditional pain relievers.
Repercussions of VIGOR Results
The VIGOR results were published in March 2000 and immediately raised concern in the medical community. However, Merck continued to reinforce "favorable cardiovascular safe of Vioxx" while marketing and selling the drug. According to Dr. Topol, one of the clinical Vioxx researchers, "the company sponsored countless continuing "medical education" symposiums at national meetings in an effort to debunk the concern about adverse cardiovascular effects. The message that was duly reinforced was that rofecoxib had no cardiovascular toxicity: rather, naproxen was "cardioprotective."
The company submitted the results of the VIGOR study to the FDA only a year later, in February 2001. After reviewing the data, the FDA requested Merck to introduce warnings on Vioxx labels that reflected the VIGOR study findings. "The new Vioxx label, which went into effect in April 2002, listed the good news about fewer upset stomachs first. Then it added two tables with the bad news about more heart attacks and strokes," reported The Wall Street Journal investigators on November 1, 2004.
Four and a half years after the VIGOR study findings were published, Merck voluntarily withdrew Vioxx from the market due to severe cardiovascular side effects reported in an internal study. If you have been taking Vioxx and have developed cardiovascular problems as a result, please consult an experienced consumer attorney as you might be entitled to compensation. Vioxx personal injury lawyers will thoroughly discuss your case to determine if it might be beneficial to file a personal injury lawsuit. In addition, in complex situations these legal professionals can recommend other lawyers specializing in other areas of law, such as auto accident lawyers, DUI specialists and family law experts.