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VIOXX® Health Risks - Research Studies
The VIGOR Study The year after VIOXX® was approved for use by the FDA, a study was reported in the New England Journal of Medicine that raised concerns about the safety of VIOXX®. The study, identified as the "VIOXX® Gastrointestinal Outcomes Research" study ("VIGOR"), looked at some 8,076 older patients who suffered from rheumatoid arthritis. Study participants were divided into two groups: one group taking 50mg of VIOXX® daily and the other group taking 500mg of Naproxen (an older NSAID) twice daily. On average, the patients were followed for a period of nine months. Though the study was designed to look at the effect the two medications have on the patients' gastrointestinal systems, the results signaled an increased risk of cardiovascular events among those patients taking VIOXX®. The VIGOR data collected at 10.5 months of the study, demonstrated that of the 4,047 patients taking VIOXX®, 45 (or 1.11%) suffered serious thrombotic cardiovascular events whereas among the 4029 patients taking Naproxen, 19 (.47%) suffered serious thrombotic cardiovascular events. This data suggested that there was a 2.36 increase in the risk of suffering a thrombotic cardiovascular/cerebrovascular event among users of VIOXX® compared to those using Naproxen. The VIGOR data broke down as follows:
Merck's interpretation of these data was not that VIOXX® carried any increased risk but that Naproxen reduced the risk of thrombotic cardiovascular events. The Kaiser-Permanente Study In August 2004, a researcher at the FDA reported the results of a retrospective study in which he reviewed the medical records for approximately 1.4 million patients of the health organization Kaiser-Permanente. Of these 1.4 million patients, over 40,000 were taking Celebrex® and almost 27,000 were taking VIOXX®. Others were taking older anti-inflammatory drugs such as aspirin, ibuprofen and naproxen. According to this FDA researcher, who reported his findings at an international conference in Bordeaux, France:
The APPROVe Study On September 30, 2004, Merck announced that it was voluntarily withdrawing VIOXX® from the market based on data generated during the course of a clinical trial designed to assess whether or not VIOXX® could prevent the recurrence of colorectal polyps in patients who had a history of colorectal cancer. The study, Adenomatous Polyp Prevention on VIOXX® (APPROVe), began enrolling patients 2000 and had enrolled approximately 2,600 patients. Data from the APPROVe study demonstrated that those taking VIOXX® for 18 or more months were at an increased risk of developing cardiovascular disease thatn those taking placebo (sugar pill). According to early reports about the data, those taking VIOXX® were twice as likely to develop serious cardiac disease than those taking plcebo - 15 cases of heart attack, stroke or blood clots over 1 year for VIOXX® users as compared to 7.5 cases per year for those on placebo. The president of Merck Research Labs is quoted as saying "What we saw was stunning." According to Merck, the APPROVe data indicated a doubling of the risk of cardiovascular disease after a patient was on the drug for 18 months or longer. However, many doctors and scientists cannot rule out similar risk for those who took VIOXX® for shorter periods of time. If you or a loved one has suffered a heart attack, heart arrhythmia, stroke or sudden cardiac death while taking VIOXX® and have questions about your legal rights, fill out our free case evaluation form. Choose the state where you live to locate a Vioxx lawyer near you. |
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