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Below is a summary of the important aspects of our Vioxx® investigation as well as some frequently asked questions regarding Vioxx®. Some of the following information was gathered from the New England Journal of Medicine article entitled "Failing the Public Health - Rofecoxib, Merck, and the FDA" by Eric J. Topol, M.D. (New England Journal of Medicine: Perspective, October 6, 2004)
In the five-and-a-half year period since Vioxx® was introduced neither Merck or the FDA has lived up to its responsibilities to protect the public. The pivotal study submitted to the FDA that ultimately led to the approval of Vioxx® contained only 8076 patients and contained insufficient cardiovascular data. Because its submission to any peer-review documents was delayed for over one-and-a-half years, it went unknown that the cardiovascular data in the study was incomplete.
It took from 1999, when Vioxx® was approved, until February 2001, for the FDA Arthritis Advisory Committee to meet and discuss concerns over potential cardiovascular risks associated with Vioxx®. Dr. Topol and his colleagues concluded that, based on a clear-cut excess number of myocardial infarctions, it should be mandatory to conduct a trial specifically assessing cardiovascular risk.
Over the next four years several independent studies were conducted, covering up to 1.4 million patients. Many of those studies confirmed the risk of serious cardiovascular events associated with the use of rofecoxib. Merck's response to these studies always included claims that that particular study was flawed. All the while, Merck was spending more than $100 million dollars per year in marketing for Vioxx®.
Finally, on September 30, 2004, Vioxx® was withdrawn from the market. This was only after 80 million patients had taken Vioxx® leading to average annual sales of $2.5 billion.
The following was taken from "Coxibs and Cardiovascular Disease" by Garret A. FitzGerald, M.D. (New England Journal of Medicine: Perspective, October 6, 2004)
One of the mechanisms employed by Rofecoxib, the "depression of protaglandin I2 formation, might be expected to elevate blood pressure, accelerate atherogenesis, and predispose patients receiving coxibs to an exaggerated thrombotic response to the rupture of an atherosclerotic plaque. The higher a patient's intrinsic risk of cardiovascular disease, the more likely it would be that such a hazard would manifest itself rapidly in the form of a clinical event."
What is Vioxx®?
Vioxx®, also known as Rofecoxib, is a drug primarily prescribed as a pain killer for those that suffer from osteoarthritis. It has also been prescribed for the treatment of acute pain in adults, relief of menstrual symptoms, and more recently for the relief of pain in both adults and children suffering from rheumatoid arthritis. The drug was marketed and manufactured by Merck & Co., Inc.
What risks are associated with Vioxx®?
Patients most at risk are those that were taking Vioxx® for the reasons above but were either suffering from cardiovascular disease prior to taking Vioxx® or began suffering from a cardiovascular disease while taking Vioxx®. Cardiovascular diseases include high blood pressure, heart attack and stroke.
What should I do if I am taking Vioxx®?
If you are taking Vioxx® you should consult with your physician immediately to discuss discontinuing the use of Vioxx®. Merck has discontinued their Patient Refund Program, but they still strongly recommend that you return any unused Vioxx® still in your possession to the NNC. Please call the National Notification Center at 1-800-805-9542 for return instructions.
Did the FDA require this action?
No, Merck made this decision independent of input from FDA. The Agency has not had an opportunity to review the data from the study that was stopped in the depth that Merck has, but agrees with the company that there appear to be significant safety concerns for patients, particularly those taking the drug chronically.
FDA plans to work closely with Merck to coordinate the withdrawal of this product from the US market.
What evidence supports the FDA Public Health Advisory?
Merck's decision to withdraw Vioxx® from the market is based on new data from a trial called the APPROVe ["Adenomatous Polyp Prevention on Vioxx®"] trial. In the APPROVe trial, Vioxx® was compared to placebo (sugar-pill). The purpose of the trial was to see if Vioxx® 25 mg was effective in preventing the recurrence of colon polyps. This trial was stopped early because there was an increased risk for serious cardiovascular events, such as heart attacks and strokes, first observed after 18 months of continuous treatment with Vioxx® compared with placebo.
Why wasn't the APPROVe trial stopped earlier?
The APPROVe trial began enrollment in 2000. The trial was being monitored by an independent data safety monitoring board (DSMB). It was not stopped earlier because the results for the first 18 months of the trial did not show any increased risk of confirmed cardiovascular events on Vioxx®.
What did FDA know about the risk of heart attack and stroke when it approved Vioxx®?
FDA originally approved Vioxx® in May 1999. The original safety database included approximately 5000 patients on Vioxx® and did not show an increased risk of heart attack or stroke. A later study, VIGOR (Vioxx® GI Outcomes Research), was primarily designed to look at the effects of Vioxx® on side effects such as stomach ulcers and bleeding and was submitted to the FDA in June 2000. The study showed that patients taking Vioxx® had fewer stomach ulcers and bleeding than patients taking naproxen, another NSAID, however, the study also showed a greater number of heart attacks in patients taking Vioxx®. The VIGOR study was discussed at a February 2001 Arthritis Advisory Committee and the new safety information from this study was added to the labeling for Vioxx® in April 2002. Merck then began to conduct longer-term trials to obtain more data on the risk for heart attack and stroke with chronic use of Vioxx®.
What other drugs are similar to Vioxx®?
Vioxx® is a COX-2 selective, nonsteroidal anti-inflammatory drug (NSAID). Other COX-2 selective NSAIDs on the market at this time are Celebrex® (celecoxib) and Bextra® (valdecoxib). Vioxx® is also related to the nonselective NSAIDs, such as ibuprofen and naproxen. You should consult your physician to determine which treatment is right for you.
Does Merck's action suggest that other drugs in the same class are dangerous?
The results of clinical studies with one drug in a given class do not necessarily apply to other drugs in the same class. All of the NSAIDs have risks when taken chronically, especially of gastrointestinal (stomach) bleeding, but also liver and kidney toxicity. Patients using these drugs for a long period of time (longer than two weeks) should be under the care of a physician.
Can my pharmacist continue to fill my prescription for Vioxx®?
No, Merck is initiating a market withdrawal in the United States to the pharmacy level. This means Vioxx® will no longer be available at pharmacies.
If you believe that you or a relative were injured by taking Vioxx® please use the form below to contact our law firm.
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