NEW YORK -- Pharmaceutical giant Merck & Co. is pulling its blockbuster arthritis and acute pain drug Vioxx from the market worldwide because new data from a clinical trial found an increased risk of heart attack and stroke.
Merck said Thursday that data from the trial showed the increased risk of heart attack and other cardiovascular complications began 18 months after patients started taking Vioxx.
The company's decision, which is effective immediately, is based on new data from a three-year study aimed at showing that Vioxx at a 25-milligram dose prevents recurrence of colorectal polyps.
The trial was stopped after Merck discovered there was an increased risk for heart attack and stroke beginning after 18 months of treatment in the patients taking Vioxx, compared to those taking a placebo.
About 2 million people worldwide take Vioxx, making it the 16th most-used drug in the United States, according to CNN.
One industry analyst called this a disaster for Merck.
Worldwide sales of the drug were $2.5 billion in 2003. But sales dipped 18 percent in the second quarter of this year, partly due to increasing concerns about the drug's safety.
Before Thursday's announcement, Merck remained comfortable with its 2004 earnings per share guidance of $3.11 to $3.17. The company expected earnings per share to drop by 50 cents to 60 cents as a result of the recall.
Investors are already bailing on the stock. Merck shares were recently down 26 percent in New York Stock Exchange trading.
The news should benefit rival Pfizer, which produces the market-leading Celebrex arthritis drug and its successor named Bextra.
"We are taking this action because we believe it best serves the interests of patients," said Raymond Gilmartin, chairman, president and chief executive officer 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."
Vioxx was approved for sale in the United States in 1999 for treating pain and inflammation caused by osteoarthritis. It has been marketed in more than 80 countries, and in some countries, it's marketed as Ceoxx.
"While the cause of these results is uncertain at this time, they suggest an increased risk of confirmed cardiovascular events beginning after 18 months of continuous therapy. While we recognize that Vioxx benefited many patients, we believe this action is appropriate," said Peter Kim, president of Merck Research Laboratories.
Merck expects that, worldwide, about one month of inventory is held by customers and will be returned.
Merck has informed the U.S. Food and Drug Administration and regulatory authorities in other countries of its decision. The company also is in the process of notifying health care practitioners in the United States and other countries where Vioxx is marketed.
Patients who are currently taking Vioxx should contact their health care providers to discuss discontinuing use of Vioxx and possible alternative treatments. For more information, visit merck.com, vioxx.com, or the Food and Drug Administration's Vioxx page. Patients and health care professionals with questions can also call (888) 36-VIOXX (1-888-368-4699). One Vioxx user said she was "stunned" at the recall.
AnnaMarie DeCarlo said she's taking the information "very, very seriously." She said she has used the drug for about eight months for shoulder pain and that it was "absolutely terrific."
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