VIOXX On September 27, 2004, Merck withdrew Vioxx from the U.S. market because of research linking it to an increase in the risk of blood clots, heart attacks and strokes. The FDA approved Vioxx in 1999 for the reduction of pain and inflammation caused by osteoarthritis, as well as acute pain in adults and for the treatment of menstrual pain. Subsequently, the FDA approved Vioxx to treat the signs and symptoms of rheumatoid arthritis in adults and children. A study done in June 2000 called VIGOR (Vioxx Gastrointestinal Outcomes Research) found that compared to patients on naproxen, those taking Vioxx had an increased risk of serious cardiovascular episodes, including heart attacks and strokes. Merck tried to downplay the results of the study by claiming that the difference in results was not because of Vioxx, but was because naproxen is "heart-protective." A study was also conducted on patients who were at risk for developing recurrent colon polyps. On September 27, 2004, the Data Safety Monitoring Board for this ongoing long-term study of Vioxx recommended that the study be stopped early for safety reasons. The study showed an increased risk of cardiovascular events, including heart attack and stroke, in patients taking Vioxx compared to those on placebo. According to the Wall Street Journal, internal documents show that Merck had knowledge of the potential hazards of Vioxx for years, yet, it steadfastly suppressed such information and retaliated against researchers who spoke out against Vioxx. Vioxx is classified as and known as COX-2 inhibitors, or coxibs. COX-2 inhibitors, like older drugs such as ibuprofen and naproxen, are nonsteroidal anti-inflammatory drugs, or NSAIDs. Older NSAIDs reduce inflammation by blocking an enzyme called COX-2, but they also block another enzyme called COX-1. This enzyme helps protect the lining of the stomach, so blocking COX-1 can cause stomach irritation. COX-2 inhibitors only block COX-2, leaving the stomach-protecting COX-1 alone. The annual rates of heart attack in Vioxx (rofecoxib) studies were increased compared to a review of studies containing a total of more than 48,000 patients. In those studies, 0.52% of patients taking an inactive placebo pill had a heart attack each year. The annual rate of heart attack was 0.74% for patients taking rofecoxib. Khorrami Pollard & Abir is currently prosecuting individual and class action cases involving Vioxx. We are capable of servicing clients from coast to coast. For further information and a free consultation, please contact us either electronically or by telephone at (866) 546-7266. View the FDA's information page on COX-2 and Non-Selective Non-Steroidal Anti-Inflammatory Drugs What is Vioxx Vioxx is a member of a new category of drugs released onto the market in the late 1990's. These new drugs were known as "Cox Inhibitors." They are related to a class of drugs called Non-steriodal Anti-inflammatory Drugs (NSAID's for short). We all know, and have used, these NSAID's under their more common names such as ibuprofen and naproxen. Although related to traditional NSAID's, Cox inhibitors operate inside the body in a different fashion. NSAID's provide pain relief and anti-inflammatory effects by blocking the body's production of both Cox-1 and Cox-2 isoenzymes. The problem with NSAID's arises out of their inhibition of the production of Cox-1. Cox-1 provides protection to the gastrointestinal system. Thus, when production of Cox-1 is eliminated, serious gastrointestinal problems can occur. Vioxx however, operates to selectively inhibit the production of the Cox-2 isoenzyme while leaving unaffected the body's production of Cox-1. Cox-2 normally is produced at sites of inflammation within the body. Thus, Vioxx has been designed to target and inhibit the production solely of Cox-2. The theoretical benefit of selective Cox-2 inhibition is that it reduces inflammation and accompanying pain, while eliminating the gastrointestinal problems associated with traditional NSAID's. Unfortunately, research has indisputably proven that selective Cox-2 inhibition throws off the body's normal balance. When this homeostatic balance is disrupted a chemical imbalance occurs that results in the development of blood clots. These blood clots form within the vascular system and tend to develop in the coronary arteries or the arteries of the brain. When this occurs heart attacks and strokes usually result. Vioxx Side Effects Recently a report in the Journal of the American Medical Association linked Vioxx to blood clots, heart attacks, and strokes. Other serious side effects associated with Vioxx usage are: Serious stomach problems, such as stomach and intestinal bleeding, which can occur with or without warning symptoms. These problems, if severe, could lead to hospitalization or death. Although this happens rarely, you should watch for signs of this serious side effect. Serious allergic reactions including swelling of face, lips, tongue, and/or throat which may cause difficulty breathing or swallowing occur rarely but may require treatment right away. Serious kidney problems occur rarely, including acute kidney failure and worsening of chronic kidney failure. Severe liver problems occur rarely in patients taking NSAIDs. Tell your doctor if you develop symptoms of liver problems. These include nausea, tiredness, itching, tenderness in the right upper abdomen, and flu-like symptoms. More common, non life-threatening, side effects associated with Vioxx include: Upper and/or lower respiratory infection and/or inflammation Headache Dizziness Diarrhea Nausea and/or vomiting Heartburn, stomach pain and upset Swelling of the legs and/or feet High blood pressure Back pain Tiredness

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