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FDA Rejects Vioxx Successor Drug for Arthritis


Posted on Apr 30, 2007

defective drug lawsuitsThose who suffer and receive treatment for arthritis in North Carolina should be aware of reports of injury risks from certain arthritis medications. On April 27, 2007 The Food and Drug Administration (FDA) formally rejected Arcoxia (Etoricoxib), a non-steroidal anti-inflammatory drug as Merck’s successor to the anti-arthritis medication, Vioxx (Rofecoxib). Learn what you should do if a drug you are taking is recalled.

Defective drug lawsuits in North Carolina are one of the more complicated injury claims to pursue. As a board-certified trial lawyer, Brent Adams has a successful record representing injured persons in North Carolina courts. As recently as late 2012, the Department of Justice announced reports that shows the pharamaceutical industry in the US still leads the nation as the top defrauder.

Arcoxia, Merck’s experimental painkiller, is a Cox-2, selective inhibitor anti-inflammatory, is reportedly less likely to cause stomach bleeding, but still poses cardiac risks. In the same class as Vioxx, Arcoxia is approved in 63 countries and sales reached $265 million in 2006. Merck claims Arcoxia is successful in treating symptoms of osteoarthritis and rheumatoid arthritis. According to the American Academy of Neurology (AAN), the FDA’s Arthritis Drugs Advisory Committee said the cardiovascular risks of Arcoxia outweigh the benefits in treating arthritis.

There is no cure for the roughly 100 types of arthritis, but early diagnosis can prevent joint deformity and permanent disability. According to Dr. Scott J. Zashin, M.D., clinical assistant professor at the University of Texas Southwestern Medical School, Division of Rheumatology in Dallas, some patients experience a remission of symptoms with medicinal treatment.

Merck pulled Vioxx in September 2004 after research showed it doubled the risk of heart attacks and strokes. It had gained FDA approval in 1999. NewsTarget.com reported the drug contributed to upwards of 139,000 heart attacks, 35% of which were fatal. Vioxx hit its peak in 2003 with $2.5 billion in sales throughout 80 countries. Personal injury lawsuits against Merck may exceed 100,000, according to US District Court Judge Eldon Fallon who is shepherding Vioxx litigation.

In the first Vioxx wrongful death lawsuit in August 2005, a Texas jury awarded $253 million to the widow of a man who died of a heart attack while taking the drug. The settlement breakdown was $450,000 for economic damages, $24 million for mental anguish and loss of companionship, and $229 million in punitive damages. Merck is appealing the court ruling.

In April 2005, Pfizer voluntarily pulled its Cox-2, selective inhibitor drug Bextra (Valdecoxib) from the market after the FDA concluded it could cause severe skin reactions.

Recently, doctors questioned Merck’s research, which compared Arcoxia to another anti-inflammatory drug, Voltarein (Diclofenac) -- used elsewhere, but not in the United States--that elevated risks of heart attacks and strokes. Merck said the two drugs have similar cardiovascular risks. Arcoxia causes high blood pressure in more patients than Diclofenac. Arcoxia previously was rejected by the FDA due to an insufficient benefit-to-risk profile.

The Journal of the American Medical Association reported Vioxx and Diclofenac have similar cardiovascular risks. In Merck’s own study, it reported Arcoxia and Diclofenac have similar risks. JAMA reported Vioxx raised cardiac risks by 35% while Diclofenac raised rates by 40%. 

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