Vioxx And Cardiovascular Risks

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You might not recognize the generic drug name, rofecoxib, but you have probably heard its brand name, Vioxx. This drug was developed by Merck & Co. pharmaceuticals in the 1990s and was approved for sale by the Food and Drug Administration (FDA) in 1999. The drug was intended to alleviate pain associated with arthritis and menstrual cramps, among other pain-related symptoms, and initial reports suggested it was doing just that, with reduced side effects when compared to other nonsteroidal, anti-inflammatory medications like it.

Vioxx would eventually be prescribed to at least 80 million people across the globe. It was recommended by doctors because it seemed to work well, and its side effects were just the usual, negligible ones: nausea, dizziness, and headaches. While most other non-steroidal, anti-inflammatory drugs (NSAID) could lead to ulcers, Vioxx seemed to have little impact on the lining of the stomach.
Some claimed that Vioxx was causing cardiovascular risks among people who took it, especially if they taken for longer than 18 months. It had only been tested for several months before it was approved by the FDA, so the long-term effects were not necessarily known. The FDA relied on Merck's own clinical test results instead of conducting their own studies. When they finally got around to investigating the company, many people had already suffered the consequences of the delay.

The connection between Vioxx and cardiovascular complications is not entirely certain, but there are several theories. The most widely believed theory is that Vioxx attacks an enzyme called COX-2, which causes pain and inflammation, but also regulates the cardiovascular system by producing an anti-clotting agent for the blood. When Vioxx kills COX-2, it is believed that it also leads to clotting. Merck claims that animal tests conducted did not yield these results. In reality, the company had neglected to conduct observational studies that included a placebo group, stating that this would have been unethical because these individuals would not have been relived of their pain. Consequently, the Merck studies produced insufficient data because no comparison could be made. Some speculate that the company deliberately misled the public into thinking the drug was safe, since, at the time, they had already generated over $2 billion dollars in Vioxx sales.

According to the FDA, as many as 130,000 heart attacks have been caused by Vioxx, and around 30 percent of these incidents were fatal. As a result, Merck voluntarily withdrew Vioxx from the market in 2004, and lawsuits were filed almost immediately. It is estimated that over $4.85 billion dollars were spent on settlements from personal injury and product liability claims filed against them. Although Merck's vioxx incidents have been cause for public speculation, they have also forced the FDA to take stronger initiatives when evaluating the safety of prescription medications before they are approved for sale on the market. Many felt that the FDA was also at fault for not funding studies of the drug efficiently enough. Nevertheless, lawsuits filed have set precedence for future drug safety regulations. They have set federal standards for pharmaceutical giants to adhere to.

If you have suffered from the adverse effects of Vioxx, you may have grounds for a legal claim. Contact an attorney in your area to evaluate evidence and assess your case. They can indicate whether or not your case is worth pursing and can predict possible compensation. The attorney must have experience with personal injury or product liability cases. It is best if the attorney has had previous pharmaceutical company caseloads. More importantly, your chosen attorney should be willing to work with you in order to reach a reasonable settlement needed to pay medical expenses and doctor's bills. It is imperative to take legal action so that pharmaceutical companies understand the consequences of their actions. You must also act quickly because statute of limitations laws set strict time regulations for filing claims. These time constraints vary by state, but can prevent you from making a claim if not considered. Locate a lawyer in your area that can walk you through the litigation processes.