February 2005
The arthritis drug Vioxx may have caused up to 140,000 excess cases of serious heart disease in the U.S.– many potentially fatal — by the time Merck & Co. withdrew it from the market. This is the conclusion of a study published by David Graham, associate director for science in the U.S. Food and Drug Administration’s (FDA) Office of Drug Safety, in the medical journal, Lancet.
When Merck withdrew Vioxx in September, the pharmaceutical giant said a study showed that people who took Vioxx for more than 18 months had double the risk of heart attack or stroke versus those taking a placebo. Dr. Graham’s 5-year study of 1.4 million California patients concluded that people who took Vioxx had a 34% higher chance of coronary heart disease when compared to people who used other anti-inflammatory painkillers. The Lancet article states that patients who took higher than 25 milligrams a day were three times as likely to have a heart problem.