Vioxx

Rofecoxib
Rofecoxib is a nonsteroidal anti-inflammatory drug (NSAID) marketed by Merck & Co. to treat osteoarthritis, acute pain conditions, and dysmenorrhoea. Rofecoxib was approved as safe and effective by the Food and Drug Administration (FDA) on May 20, 1999, and was subsequently marketed under the brand name Vioxx, Ceoxx and Ceeoxx.
Rofecoxib gained widespread acceptance among physicians treating patients with arthritis and other conditions causing chronic or acute pain. Worldwide, over 80 million people were prescribed rofecoxib at some time.
On September 30, 2004, Merck voluntarily withdrew rofecoxib from the market because of concerns about increased risk of heart attack and stroke associated with long-term, high-dosage use. Rofecoxib was one of the most widely used drugs ever to be withdrawn from the market. In the year before withdrawal, Merck had sales revenue of US$2.5 billion from Vioxx. [1]
Rofecoxib was available on prescription as tablets and as an oral suspension.
Adverse drug reactions
See also: Non-steroidal anti-inflammatory drug

Adverse drug reaction
Aside from the reduced incidence of gastric ulceration, rofecoxib exhibits a similar adverse effect profile to other NSAIDs. Rofecoxib, however, does appear to increase the risk of adverse cardiovascular events.
The chief mechanism proposed to explain rofecoxib's cardiotoxicity is the suppression of prostacyclin, an anti-clotting agent in the blood (Fitzgerald, 2004). COX-2 plays a role in the production of prostacyclin. Because Vioxx inhibits the COX-2 enzyme, prostacyclin production can decrease in endothelial cells and lead to an inefficiency in declumping and vasodilatation. Merck, however, argues that there was no effect on prostacyclin production in blood vessels in animal testing.[3] Other researchers have speculated that the cardiotoxicity may be associated with maleic anhydride metabolites formed when rofecoxib becomes ionized under physiological conditions. (Reddy & Corey, 2005)
Political impact of Vioxx litigation in America
The recall and litigation over rofecoxib has provoked debate over drug safety in the United States. Some[who?] argue that the U.S. Food and Drug Administration does not do enough to monitor product safety and that the rofecoxib withdrawal is an argument against tort reform. It has also been argued[who?] that litigation is an imperfect means of regulation that would overdeter companies for complying with FDA requirements, and that large awards like that in Ernst would inhibit research and development