Health
Manufacturer voluntarily withdraws popular arthritis drug
NEWS IN BRIEF — Posted Oct. 18, 2004
Merck & Co. Inc, announced last month that rofecoxib (Vioxx) would be withdrawn voluntarily from the market because of studies linking the pain reliever to an increased risk of heart attack and other cardiovascular events.
"We are taking this action because we believe it best serves the interests of patients," said Raymond V. Gilmartin, chief executive officer of the company.
Merck's decision was based on the results of the Adenomatous Polyp Prevention on Vioxx trial, which found no increased risk in the first 18 months of the study but did at the three-year point. This discovery also ended the study early.
The drug has long been dogged by questions of cardiovascular safety. In its phase III studies before approval, no problems emerged, but other studies suggested otherwise. Most recently, a retrospective analysis of Kaiser Permanente's records presented in August at the International Society for Pharmacoepidemiology Conference in Bordeaux, France, found that the drug could triple the risk of heart attack.
The Food and Drug Administration advised patients to consult with physicians about other medications.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2004/10/18/hlbf1018.htm.
