About VIOXX^®

Originally approved by the FDA in May 1999, VIOXX^® was prescribed for over 20 million Americans over a five year period. Hailed by Merck as a miracle drug, VIOXX^® was marketed to treat all types of acute pain without causing serious gastrointestinal discomfort and bleeding like aspirin, Aleve and Advil. Before its withdrawal, VIOXX^® was the second most prescribed drug in the world, with annual sales of $2.5 billion.

An aggressive $500 million advertising campaign marketed VIOXX^® directly to the consumer through television, radio and print ads. This marketing campaign was closely watched by the FDA because sales representatives were telling physicians that VIOXX^® did not cause cardiovascular events. Ultimately, the FDA warned Merck in September 2001 that their sales representatives had "engaged in false or misleading promotional activities" and that the campaign "minimizes the potentially serious cardiovascular findings" about the drug. In April 2002, the FDA required Merck to change the label on VIOXX^® to include a disclosure about the risk of cardiovascular problems.

According to internal memoranda and documents, Merck had concerns about the safety of VIOXX^® as early as 2000 when a study showed that patients taking VIOXX^® for longer than 18 months were twice as likely as those taking a placebo to suffer a heart attack or stroke. The VIOXX GI Outcomes Research ("VIGOR") clinical trial began in January 1999 to determine whether VIOXX^® was safer on the stomach than Naproxen, an older pain medication. The results of the study showed that VIOXX^® caused fewer gastrointestinal issues but that patients on VIOXX^® were nearly five times more likely to suffer a heart attack.

In November 1999, Merck commenced the Adenomatous Polyp Prevention on VIOXX^® (APPROVe) study to examine the effects of VIOXX^® on the recurrence of colon polyps in 2600 patients with no cardiovascular problems. That study was stopped abruptly after investigators found that patients taking VIOXX during the study had twice the risk of heart attack as those patients on the placebo. It was the result of this study that finally prompted Merck to withdraw VIOXX^®.

The FDA estimates that VIOXX^® caused over 100,000 heart attacks and 27,000 sudden cardiac deaths from 1999 to 2003.