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Vioxx: Fda Office
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Vioxx information on potential side effects was not fully known at the time Vioxx arthritis drug was received FDA approval in May 1999. Although Vioxx information on more common side effects such as heartburn, vomiting, upset stomach, and other events were recognized, more Vioxx information would come to light. Soon, Vioxx information was showing that the arthritis drug carried risk of serious cardiac events. Researchers provided Vioxx information showing the likelihood of suffering a heart attack was four times the risk than if using an older arthritis pain reliever.
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Recently, on August 25, 2004, a study financed by the FDA found that people taking the recommended dose of Vioxx were at 3 times the risk of heart attack and sudden death compared to persons taking other, non-steroidal painkillers. Further, those taking Vioxx had a 50% greater chance of sudden cardiac death or heart attack than those using Pfizer’s Celebrex, a rival medicine. These results were based on a review of the medical records of over 1.4 million people.
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Recently, an advisory panel of the Food and Drug Administration recommended to the FDA that Vioxx's label should warn physicians and patients of a possible increased risk of heart attacks or other adverse cardiovascular events. In addition, an article recently appeared in the Journal of the American Medical Association that raises "a cautionary flag" about the risk of heart attacks or other adverse cardiovascular events associated with the usage of COX-2 inhibitors such as Vioxx and Celebrex. COX-2 inhibitors such as Vioxx and Celebrex have been shown to increase blood pressure in patients, which in turn can increase a patient's risk of stroke, heart attack, and/or other adverse cardiovascular events. In addition, the makers of Vioxx and Celebrex have received several reports of possibly kidney dysfunction and/or kidney failure associated with the usage of these drugs.
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Minor side effects with the use of Vioxx include upset stomach, dizziness, heartburn, vomiting, and constipation. In March 2002 an FDA report linked Vioxx to five cases of a nonbacterial type of meningitis. In May 2002 a report published in the Journal of Bone and Mineral Research stated that it may ... impede bone repair due to the arthritis drug inhibiting cox-2 (which assists bone-forming cells in the healing process.)
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Vioxx was approved by FDA in May 1999 for the relief of the signs and symptoms of osteoarthritis, for the management of acute pain in adults, and for the treatment of menstrual symptoms. It was later approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children. Serious concerns have been raised regarding the use of Vioxx, Vioxx side effects on kidney and cardiovascular health, and the increased risk of heart attack and stroke. Experts predict the final damages amount to be in the billions.
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An FDA expert advisory panel voted in February that Vioxx could be allowed back on the market for selected patients, but yesterday's verdict made that possibility more remote. The next big case is scheduled to begin in a New Orleans federal court in November.
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