The chairman, president and chief executive officer of Merck, Raymond Gilmartin, said in a statement on the company’s Web site, ”We are taking this action because we believe it best serves the interests of patients.”
People taking Vioxx are advised to speak with their doctor about switching to another drug or treatment. Merck says it will reimburse patients for any tablets they currently have.
Vioxx was first marketed as an anti-inflammatory drug that reduced internal inflammation causing pain in the body. It has been on the market since FDA approval in 1999. The product is marketed under the trademark Ceoxx in some countries and worldwide sales amounted to $2.5 billion in 2003, according to the company.
“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,” company representatives wrote according to the Web site.
Merck is the world’s third-largest drug manufacturer and Vioxx was one of its most important drugs. The news sent Merck’s share price plummeting more than $12 in early trading, reducing the company’s market capitalization by about $26 billion, according to the Associated Press.
The announcement came after a three-year trial designed to evaluate the efficacy of taking the drug in preventing a recurrence of colorectal polyps in patients with a history of benign colorectal tumors, the company said.
Merck found that after 18 months of treatment, patients taking Vioxx were at greater risk for heart attacks compared with those taking a placebo.
The results confirmed the findings of an FDA investigator who reported similar risks with the drug in August. In that study, Dr. David Graham found that the difference in heart risk was statistically significant between a recommended dose of Vioxx, 25 milligrams a day or less, and the drug’s main competitor, Pfizer’s Celebrex. Doses in excess of 25 milligrams a day more than tripled the risk, compared with patients who had not taken painkillers within the past two months.
At that time, Merck disputed the results of the study.
At a press conference Thursday morning, Gilmartin said Merck would undertake “many pro-active steps” to inform patients of the recall, including placing advertisements in newspapers. Information can be found on the Web sites merck.com and vioxx.com.