VIOXX COMPENSATION CLAIMS ADVICEThis prescription drug which is also called rofecoxib has been used by over 300,000 Australians for treatment of a variety of conditions including pain and inflammation associated with osteoarthritis, and rheumatoid arthritis. The Food and Drug Administration (FDA) approval was obtained firstly in the USA and subsequently approved in Australia on 30 June 1999. This drug has, from the very beginning, caused major controversy and has now resulted in thousands of Vioxx compensation claims around the world resulting from an increased risk of heart attacks and stokes. In March 2000, the first major study (VIGOR) conducted by Merck revealed a 5 times increased risk of heart attacks and strokes for rofecoxib users compared with users of naproxen (Naprosyn), a COX 1 inhibitor. In 2001, Merck commenced the APPROVe study, a three year trial with the primary aim of evaluating the efficacy of rofecoxib for the prevention of colorectal polyps. The APPROVe study was terminated early when the preliminary data from the study showed an increased relative risk of adverse thrombotic cardiovascular events (including heart attack and stroke), beginning after 18 months of rofecoxib therapy. It is alleged that Merck failed to warn treating doctors or patients following the results of the VIGOR study. No information, let alone warnings, about the risks were given, until some two years later. In Australia, the medicines regulator had been monitoring this drug for some time and, in October 2003, published an article in the Australian Adverse Drug Reactions Bulletin alerting Australian doctors to some evidence of increased risk of cardiovascular and cerebrovascular disease with the use of rofecoxib which appeared to be related to doses greater than 25 mg a day. This warning subsequently was in every way justified as there are now hundreds of Australians making Vioxx compensation claims. On September 30, 2004 Merck & Co., the manufacturer of this product, announced its voluntary withdrawal of rofecoxib from all markets worldwide. In Australia, the Therapeutic Goods Association dispatched recall letters on 1 October 2004. Recall notices appeared in newspapers on Saturday 2 October 2004. FDA analysts estimate that rofecoxib caused between 88,000 and 139,000 heart attacks, 30 to 40 percent of which were probably fatal, in the five years the drug was on the market. It has been estimated that the final cost of all Vioxx compensation claims may exceed $30 million. What is rofecoxib and how does it work? This drug is a COX-2 inhibitor and a non-steroidal anti-inflammatory drug (NSAID). Prostaglandins are chemicals that are important in promoting inflammation and its signs--pain, fever, swelling and tenderness. Rofecoxib blocks the enzyme that makes prostaglandins (cyclooxygenase-2) and thereby reduces the amounts of prostaglandins. As a consequence, inflammation and its accompanying pain, fever, swelling and tenderness also are reduced. Rofecoxib tablets in Australia, came in the following doses:
For the management of osteoarthritis, the usual dose was 12.5 mg (tablet or suspension) once daily.The maximum dose was 25 mg once daily. For the treatment of acute pain and menstrual cramps the usual dose was 50 mg once daily. The drug-maker Merck estimates that 13 and 24 million patients have been prescribed the drug in the U.S. and worldwide, respectively. Rofecoxib has been associated with many serious side-effects, such as Heart Attack, Stroke, Blood Clots, Angina, Ulcers/Bleeding, Kidney Damage, Severe Intestinal Damage. Australian Class Action - Multi Party Action On 9 November 2007 a class action agreement was reached for VIOXX victims resident in the United States. VIOXX victims from Australia are not entitled to make a claim for compensation under this scheme as a result of which the class action currently running in the Federal Court of Australia will continue to final resolution. An individual qualifies as a group member of this class action if they were prescribed and took VIOXX in Australia after 30 July 1999 and were diagnosed with heart attack, stroke, angina, ischemic attack or peripheral vascular disease within 30 weeks of completing the course. Those who qualify are automatically group members unless they opted out on or before 27 October 2006 and will be bound by any subsequent judgment and will not be able to commence a separate legal proceedings in Australia. NO WIN NO FEE |