Market Withdrawal of Vioxx: Is it Time to Retihink the Use of COX-2 Inhibitors?

On September 30, 2004, Merck and Co. Inc., the manufacturer of the arthritis drug rofecoxib (Vioxx), announced the worldwide voluntary market withdrawal of rofecoxib after a study confirmed long-standing concerns that use of the drug raises the risk of heart attack and stroke.1 The drug was aggressively marketed after receiving U.S. Food and Drug Administration (FDA) approval in 1999 and has resulted in more than 84 million prescriptions worldwide. More than 2 million people were taking Vioxx at the time of the recall, making this the largest voluntary drug recall in history. The recall has substantial financial implications as well. Vioxx brought in more than $2.5 billion annually for Merck and was responsible for approximately 10% of its worldwide sales.