VIOXX RECALL INFORMATION

Merck & Co. has removed its blockbuster arthritis drug Vioxx from the market worldwide because new data from a clinical trial found an increased risk of heart attack and stroke. Merck decided to remove the drug from the market
after data from the trial showed an increased risk of heart attack, stroke, blood clots and other cardiovascular complications.

The data comes from a three-year study aimed at showing that Vioxx at a 25 milligram dose prevents recurrence of polyps in the colon and rectum. The trial was stopped after Merck discovered the higher heart risk compared to patients taking dummy pills.

Before the withdrawal of Vioxx, the FDA announced that patients taking Vioxx have a 50 percent greater chance of heart attacks and sudden cardiac death. The study, presented at an epidemiologists conference, also found patients taking the highest recommended daily dosage of Vioxx had three times the risk of heart attack and sudden cardiac death as those not taking standard painkillers.

The popular and heavily advertised arthritis drugs Vioxx and Celebrex have been linked by researchers to an increase in the risk of blood clots, heart attacks and strokes.The study from the Cleveland Clinic appeared in the Journal of the American Medical Association and was based on an analysis of previous clinical trials. Celebrex and Vioxx are projected to produce U.S. sales greater than $6 billion this year.

In a study of more than 8,000 patients that compared the COX-2 inhibitor rofecoxib Vioxx) with the traditional NSAID naproxen, the risk of cardiovascular problems, including heart attack,chest pain related to heart disease, stroke, sudden death and blood clots, was more than two times higher in the rofecoxib group than in the naproxen group.

Vioxx like Celebrex is classified as and known as COX-2 inhibitors, or coxibs. COX-2 inhibitors, like older drugs such as ibuprofen and naproxen, are nonsteroidal anti-inflammatory drugs, or NSAIDs. Older NSAIDs reduce inflammation by blocking an enzyme called COX-2, but they also block another enzyme called COX-1. This enzyme helps protect the lining of the stomach, so blocking OX-2 can cause stomach irritation. COX-2 inhibitors only block COX-2, leaving the stomach-protecting COX-1 alone.

In 2000 Merck spent $160.8 million on direct to consumer Vioxx marketing. Many people are familiar with Vioxx television advertisements featuring the famous figure skater Dorothy Hamill. Sid Wolfe, a physician and director of the Health Research Group of the advocacy group Public Citizen in Washington, D.C. said "Dorothy Hamill doesn't tell people they have a four times higher risk of a heart attack on Vioxx."

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Case Information:

During what period of time was Vioxx prescribed? Start End Why was Vioxx prescribed? What dosage of Vioxx were you prescribed daily? (i.e. 25mg, 50mg, 75mg) List names/addresses of any doctors who prescribed Vioxx: Did effects from Vioxx include: Heart Attack Yes No Stroke Yes No Deep Vein Thrombosis Yes No Blood Clots Yes No Pulmonary Embolism Yes No Kidney Problems Yes No Death Yes No Other medical problems since Vioxx usage: Date medical problem(s) first occurred: Other Information:

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