Vioxx

On September 30, 2004 , the popular arthritis drug Vioxx was pulled off the shelves worldwide after a clinical study confirmed concerns that it raises the risk of heart attack and stroke, which can lead to serious and permanent injuries and death. Over 105 million Vioxx prescriptions have been written in the US alone.

Vioxx (Rofecoxib) is a Cox-2 inhibitor drug that was approved by the US Food and Drug Administration in 1999 for the treatment of arthritis, osteoarthritis, menstrual pain and for the management of acute pain in adults. Its active ingredient is rofecoxib.

Serious concerns have been raised in recent months regarding the use of Vioxx, its side effects on kidney and cardiovascular health, and the increased risk of heart attack and stroke.

Vioxx is an anti-inflammatory drug, which means it reduces internal inflammation. Vioxx, along with Aspirin, is part of the class of drugs known as nonsteroidal anti-inflammatory drugs (NSAID) - i.e. it is not a steroid. Vioxx is analgesic, (it eliminates pain) and it is antipyretic (it reduces fevers).

Previous clinical trials had linked Vioxx to an increase in blood clots and other cardiovascular problems, including heart attack, chest pain related to heart disease, stroke and sudden death. Vioxx users were more than twice as likely to experience heart problems than patients using the control drug.

It yanked Vioxx three years after the first studies raised safety alarms.

Forbes.com October 15, 2004

On September 3, 2004 , Newton Acker, 71, died of a stroke while on a bicycling vacation with his wife in southern France . His three grown children were stunned. Apart from his arthritis, Acker was exceptionally healthy. He had low cholesterol and low blood pressure and bicycled 5,000 miles a year. His parents had lived to age 90.

Four weeks later Merck & Co. pulled Vioxx from the market after a study showed it doubled the risk of heart attacks and stroke. "That's the answer,"Acker's son, Kenneth, an F-16 training pilot in Arizona , immediately thought. His dad had been taking Vioxx for 14 months before his death. Kenneth blames Merck for failing to act sooner and plans to sue. "We don't need the money. We just want my father back," he says.

Prominent doctors are calling for congressional investigations, and European regulators are scrutinizing the safety of similar drugs such as Pfizer's Bextra and Celebrex. Merck will be lucky to survive a legal onslaught that easily could rival the $13.3 billion in damages paid out so far by Wyeth in a far smaller drug recall, the fen-phen fiasco. "This may be the biggest drug safety catastrophe in U.S. history," says Vanderbilt epidemiologist Wayne Ray, who published a study linking high doses of Vioxx to heart attacks in 2002. Until this month "there was a solid wall of denial" from Merck, he says. "We need to investigate why the [safety] signals were ignored."

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