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Unsafe Drugs
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Vioxx
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VIOXX - The drug rofecoxib, a Cox-2 Inhibitor NSAID (nonsteroidal anti-inflammatory drug,) was FDA approved in 1999 and marketed under the brand name Vioxx by Merck & Co., Inc. Vioxx was used to treat arthritis, acute pain, fever, inflammation and menstrual cycle discomfort in adults. In 2002, Merck received approval from the FDA to market Vioxx for the treatment of migraines. A later 2004 FDA approval allowed the drug to be administered to children with rheumatoid arthritis.
In 2000, the New England Journal of Medicine reported the results of the Merck-sponsored Vioxx Gastrointestinal Outcomes Research (VIGOR) trial. The findings indicated that when administered for the same conditions, the use of Vioxx did result in a decreased risk of upper gastrointestinal toxicity but represented a five-fold increased risk of a myocardial infarction as compared to the NSAID drug, Naproxen.
The FDA sent a letter of warning to Merck in 2001 prohibiting the company from conducting any promotion for Vioxx that might minimize the serious cardiovascular events documented in the VIGOR study. A subsequent black box warning was required on Vioxx packaging, and in 2002, Merck forwarded a letter to physicians advising caution in prescribing Vioxx to certain patients.
A placebo-controlled trial sponsored by Merck called the Adenomatous Polyp Prevention on Vioxx (APPROVe) study, was cut short in September of 2004. Intended to be a long-term study of the effects of rofecoxib on adenomatous polyps of the large intestines, the trial was abandoned because of a marked increase in heart attacks and strokes among trial participants. Those using Vioxx continually, even for as little as eighteen months, were deemed to be at greater risk of serious cardiovascular events. One day after the study was halted, Merck withdrew Vioxx from the market.
More than twenty-seven thousand separate lawsuits have been filed against Merck on behalf of those harmed by the drug. Recently, a 4.85 billion-dollar settlement was reached in a class-action lawsuit that represented approximately forty thousand plaintiffs.
The increased risk for heart attacks and strokes attributed to the use of Vioxx is well documented. Other symptoms of serious complications from the use of Vioxx may include, but are not limited to:
· Abdominal pain, nausea, discomfort or tenderness
· Bloody vomit or spontaneous bleeding
· Black, tarry or bloody stools
· Water retention or other unexplained increase in weight
· Yellowing of the eyes or skin
· Unexplained bruising
· Skin rash
· Symptoms that resemble the flu
If you or someone you know has taken Vioxx and experienced commonly recognized, or unexplained side effects, use the form below for a free evaluation with an attorney who specializes in Vioxx cases. Unsafe drug cases are complex and guidance by an attorney who is intimately familiar with the drug is crucial.
If you have safety concerns about the use of Vioxx, our free evaluation may provide important information.
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