VIOXX SUMMARY

Vioxx is a non-steroidal, anti-inflammatory drug (NSAID), and is in a class of drugs commonly referred to as a "Cox-2 Inhibitors." It comes in liquid or pill form and is manufactured by Merck & Co. Vioxx is prescribed to relieve the symptoms of Osteoarthritis. It can also be used to treat acute pain in adults such as those patients who experience severe pain associated with menstruation. Vioxx works by blocking COX-2 enzymes in the body that trigger pain and inflammation.

Vioxx was approved by the US Food and Drug Administration in June of 1999. It has been widely prescribed since its introduction - over 52 million times. As this drug, along with the similar drug Celebrex, came onto the market it was touted by its manufacturer as, "effective at reducing arthritis pain, inflammation and stiffness… also effective for the relief of pain and inflammation of one of the most severe forms of arthritis, rheumatic arthritis." Doctors and patients thought that they may have a perfect drug to stop arthritic and other types of pain, without the stomach irritation that was otherwise associated with NSAIDs. However, recent reports linking Vioxx to serious health problems has caused great concern for the millions of Americans taking these drugs.

Concerns about the drug began surfacing shortly after its approval. A study published in 2000 known as the VIGOR (Vioxx GI Outcomes Research) trial found an increased rate of heart attack in Vioxx patients compared to patients on another non-steroidal anti-inflammatory drug, naproxen (Aleve).The study was designed to look at the effects of Vioxx on side effects such as stomach ulcers and bleeding. Though patients taking Vioxx did have fewer stomach ulcers and bleeding, the study also showed a greater number of heart attacks in patients taking Vioxx.

At the time, Merck argued that the difference was due to a protective effect from naproxen, reducing the risk of heart attack in naproxen patients. The results of the VIGOR study were reported to the FDA, and in September 2001, the FDA sent a warning letter to Merck about Merck's improper practices in downplaying the cardiovascular risks of Vioxx. New safety information was added to the labeling for Vioxx in April 2002. Merck then began to conduct longer-term trials to obtain more data on the risk for heart attack and stroke with chronic use of Vioxx.

Vioxx News Alert: Merck withdraws Vioxx from Market
September 30, 2004

Drugmaker Merck & Co. is pulling its best-selling arthritis drug Vioxx off the market, based on data indicating the drug increases the risk of heart attack and stroke among users. The Whitehouse Station, N.J.-based pharmaceutical manufacturer said the immediate withdrawal of Vioxx was based on data from a three-year colon cancer clinical trial that showed a heightened risk of cardiovascular complications began 18 months after patients started taking Vioxx.

In addition to heart attacks and strokes, Vioxx has also been associated with several other life-threatening side effects, including blood clots, angina and nonbacterial meningitis, severe intestinal damage, ulcerations and bleeding, and kidney damage.

Many recent Vioxx lawsuits bring to light questions as to when Merck was first made aware that fatal side effects were associated with Vioxx, and whether the company failed to inform public health authorities of these side effects, in a timely manner. Additionally, Merck extensively marketed Vioxx as highly safe and effective, while minimizing its risks compared to other drugs on the market.

Additional Vioxx Recall Information

CNN: Arthritis drug Vioxx being pulled
NEW YORK (Reuters) -- The arthritis drug Vioxx, used by millions of people around the world, is being pulled off the market after a study confirmed long-standing concerns that it raises the risk of heart attack and stroke, the manufacturer, Merck & Co., said today.

Dow Average Falls After Merck Withdraws Vioxx; Nasdaq Advances
Sept. 30 (Bloomberg) -- The Dow Jones Industrial Average dropped after Merck & Co. retracted its third-quarter profit forecast because the company said it will no longer sell the Vioxx painkiller that generated $2.5 billion in sales last year.

Merck Vioxx Announcement: Merck Announces Voluntary Worldwide Withdrawal of VIOXX
Press Release for VIOXX Provided by Merck Pharmaceuticals (PDF Format)

ABC News: "A Disaster": Merck Recalls Arthritis Drug Vioxx
Merck Recalls Vioxx Because Data From Clinical Trial Finds Higher Risk of Heart Attack, Stroke

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