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NEW YORK (Sept. 30) - The arthritis drug Vioxx, used by two million people around the world, is being pulled off the market after a study confirmed long-standing concerns that it raises the risk of heart attack and stroke, the maker, Merck & Co., said Thursday.
''Patients who are currently taking Vioxx should contact their health care providers to discuss discontinuing use of Vioxx and possible alternative treatments,'' Merck said.
The company, whose stock price plunged on the news, said it was withdrawing the drug following a review of data from a three-year colon cancer trial.
''In this study, 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,'' Merck said in a press release.
The Food and Drug Administration said it would closely watch drugs in the same class as Vioxx, which would include Pfizer Inc.'s Celebrex, for signs of risk.
Worldwide sales of Vioxx totaled $2.55 billion last year. Since the introduction of the drug in 1999, 91 million Vioxx prescriptions have been written in the United States alone. The drug is sold in some countries under the name Ceoxx.
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Merck is already gearing up for lawsuits over Vioxx. ''We have substantial defenses in these cases and will defend them vigorously,'' said Kenneth Frazier, Merck's general counsel.
The setback comes at a particularly bad time for Merck, which is struggling with anemic sales and profit growth, and is slated to lose patent protection on its biggest selling drug, cholesterol fighter Zocor, in 2006.
Vioxx was one of the company's ''five key drivers for future growth,'' said Sena Lund, an analyst at Cathay Financial.
91 Million
Number of Vioxx prescriptions written in the United States since drug was introduced in 1999
2 Million
People worldwide currently taking Vioxx, according to Merck
$2.55 Billion
Sales of Vioxx worldwide last year
80
Number of countries where Vioxx has been marketed
27 Percent
Figure by which Merck shares plummeted on news of the drug maker's problems
Merck shares fell 27 percent in early trading on the New York Stock Exchange, wiping out more than $25 billion of market value. Shares of Pfizer, which sells two rival arthritis drugs, edged higher.
Merck Chairman and Chief Executive Raymond Gilmartin said he had no intention of resigning.
Vioxx sales have been flat in recent years amid safety concerns. Clinical trial data have shown the drug increased the incidence of blood clots tied to strokes and heart attacks.
A recent study by the Food and Drug Administration suggested patients taking Vioxx faced a 50 percent greater risk of heart attacks and sudden cardiac death than those taking Pfizer's Celebrex arthritis treatment.
Sales of the Pfizer arthritis drugs Celebrex and Bextra have steadily grown as doctors have turned to those drugs, which have not been linked to heart attack and stroke.
The colon cancer trial was designed to evaluate the effectiveness of the standard 25-milligram Vioxx dose in preventing recurrence of colon polyps. Such polyps sometimes become cancerous.
Vioxx was used in the colon cancer trial because some researchers theorize that inflammation, present in arthritis, may be linked to colon cancer.
Merck said the heart attacks and strokes were not spotted during the first 18 months of the trial but became apparent later.
''Given the availability of alternative therapies, and the questions raised by the data, we concluded that a voluntary withdrawal (of Vioxx) is the responsible course to take,'' Merck chief Gilmartin said.
Merck said it remains comfortable with its earnings forecast for full-year 2004 of $3.11 to $3.17 per share.
It expects the recall to drag down earnings by 50 cents to 60 cents per share because of lost sales and costs of the recall, but is uncertain when those costs will be recorded.
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NEW YORK (Sept. 30) - The arthritis drug Vioxx, used by two million people around the world, is being pulled off the market after a study confirmed long-standing concerns that it raises the risk of heart attack and stroke, the maker, Merck & Co., said Thursday.
''Patients who are currently taking Vioxx should contact their health care providers to discuss discontinuing use of Vioxx and possible alternative treatments,'' Merck said.
The company, whose stock price plunged on the news, said it was withdrawing the drug following a review of data from a three-year colon cancer trial.
''In this study, 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,'' Merck said in a press release.
The Food and Drug Administration said it would closely watch drugs in the same class as Vioxx, which would include Pfizer Inc.'s Celebrex, for signs of risk.
Worldwide sales of Vioxx totaled $2.55 billion last year. Since the introduction of the drug in 1999, 91 million Vioxx prescriptions have been written in the United States alone. The drug is sold in some countries under the name Ceoxx.
Resources
Stock Quote: MRK
Discuss: Post | Chat
Search: Vioxx
Merck is already gearing up for lawsuits over Vioxx. ''We have substantial defenses in these cases and will defend them vigorously,'' said Kenneth Frazier, Merck's general counsel.
The setback comes at a particularly bad time for Merck, which is struggling with anemic sales and profit growth, and is slated to lose patent protection on its biggest selling drug, cholesterol fighter Zocor, in 2006.
Vioxx was one of the company's ''five key drivers for future growth,'' said Sena Lund, an analyst at Cathay Financial.
91 Million
Number of Vioxx prescriptions written in the United States since drug was introduced in 1999
2 Million
People worldwide currently taking Vioxx, according to Merck
$2.55 Billion
Sales of Vioxx worldwide last year
80
Number of countries where Vioxx has been marketed
27 Percent
Figure by which Merck shares plummeted on news of the drug maker's problems
Merck shares fell 27 percent in early trading on the New York Stock Exchange, wiping out more than $25 billion of market value. Shares of Pfizer, which sells two rival arthritis drugs, edged higher.
Merck Chairman and Chief Executive Raymond Gilmartin said he had no intention of resigning.
Vioxx sales have been flat in recent years amid safety concerns. Clinical trial data have shown the drug increased the incidence of blood clots tied to strokes and heart attacks.
A recent study by the Food and Drug Administration suggested patients taking Vioxx faced a 50 percent greater risk of heart attacks and sudden cardiac death than those taking Pfizer's Celebrex arthritis treatment.
Sales of the Pfizer arthritis drugs Celebrex and Bextra have steadily grown as doctors have turned to those drugs, which have not been linked to heart attack and stroke.
The colon cancer trial was designed to evaluate the effectiveness of the standard 25-milligram Vioxx dose in preventing recurrence of colon polyps. Such polyps sometimes become cancerous.
Vioxx was used in the colon cancer trial because some researchers theorize that inflammation, present in arthritis, may be linked to colon cancer.
Merck said the heart attacks and strokes were not spotted during the first 18 months of the trial but became apparent later.
''Given the availability of alternative therapies, and the questions raised by the data, we concluded that a voluntary withdrawal (of Vioxx) is the responsible course to take,'' Merck chief Gilmartin said.
Merck said it remains comfortable with its earnings forecast for full-year 2004 of $3.11 to $3.17 per share.
It expects the recall to drag down earnings by 50 cents to 60 cents per share because of lost sales and costs of the recall, but is uncertain when those costs will be recorded.
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