Merck withdraws Vioxx after VIGOR trial data shows 4x elevated heart attack risk in long-term users

Merck voluntarily withdrew rofecoxib (Vioxx) from the global market on September 30, 2004, after the APPROVe trial confirmed the drug doubled the risk of cardiovascular events after 18 months of use. Internal Merck documents later showed the company had VIGOR trial data as early as 2000 indicating a fivefold increase in heart attack risk compared to naproxen. An estimated 88,000 Americans suffered heart attacks attributable to Vioxx, and 38,000 of them died. Merck faced more than 60,000 lawsuits and in November 2007 agreed to a $4.85 billion settlement — one of the largest pharmaceutical settlements in U.S. history.