Vioxx is the brand name of the drug Rofecoxib, a nonsteroidal anti-inflammatory drug that was marketed by Merck & Company for the treatment of acute pain, osteoarthritis, and dysmenorrhoea.

Merck & Company vs. The FDA: Early Signs of Vioxx Trouble

In September of 2004, the drug was taken off of the market by Merck & Company after evidence from a three year in-house study conducted at Merck & Company on the effects of Vioxx in the prevention of the recurring colon polyps (the APPROVe [Adenomatous Polyp Prevention on Vioxx] study) suggested an increase in cardiovascular events such as heart attack and stroke with the drug. The study concluded that the patients taking rofecoxib were twice as likely to suffer a heart attack or stroke than patients taking placebo.While the Food and Drug Administration did not require Merck & Company to recall Vioxx, it did release information from its own studies that corroborates the findings of the Merck & Company in-house study.

Merk & Company VIGOR Study:Vioxx and Cardiovascular Events

A previous in-house Merck & Company study (the VIGOR study) suggested that, while there was no risk for patients with normal cardiovascular risk, patients who were already at high risk of adverse cardiovascular events were around four times as likely to suffer a heart attack or stroke than those in the study's placebo group. As a result, a label warning of increased cardiovascular events was placed on Vioxx in April of 2002.

The Lancet and Taking Vioxx off the Market

In November 2004, British medical journal The Lancet published an analysis of the available studies on Vioxx and concluded that, given the information available to Merck & Company, Vioxx should have been taken off of the market well before 2004.