Merck said its actions today came after it found increased risk for cardiovascular problems after prolonged use in a trial testing Vioxx as a preventive for colorectal polyps.
"In this study," it said today, "there was an increased relative risk for confirmed cardiovascular events, such as heart attack and stroke, beginning after 18 months of treatment in the patients taking Vioxx compared to those taking placebo."
Release Announcing Vioxx Withdrawal (PDF)
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The company said that "the results for the first 18 months of treatment did not show any increased risk."
The trial was halted after the finding.
"We are taking this action because we believe it best serves the interest of patients," said a written statement from Raymond Gilmartin, chairman and chief executive of Merck. "Although we believe it would have been possible to continue to market Vioxx with labeling that would incorporate these new data, given the availability of alternative therapies, and the questions raised by the data, we concluded that a voluntary withdrawal is the responsible course to take."
The FDA issued a public health advisory suggesting that patients using Vioxx consult their physicians.
"Merck did the right thing by promptly reporting these findings to FDA and voluntarily withdrawing the product from the market," said a written statement by FDA Commissioner Lester M. Crawford. "Although the risk that an individual patient would have a heart attack or stroke related to Vioxx is very small, the study that was halted suggests that, overall, patients taking the drug chronically face twice the risk of a heart attack compared to patients receiving a placebo."
The company said in a statement that its fourth quarter sales would suffer to the tune of $700 million to $750 million, knocking down earnings per share by 50 or 60 cents. Merck's shares plummeted in trading after the announcement, as did the Dow Jones industrial average, which includes Merck as a component.
The COX-2 drugs are designed to fight inflammation and pain while reducing the risk of ulcers caused by over-the-counter pain medication, such as aspirin and ibuprofen. But some studies have found that COX-2 inhibitors might cause blood clots that trigger heart attack and stroke. Some subsequent studies showed Vioxx carries greater heart risk than other drugs in its class.