Chief Cushie ~MaryO~ Posted September 30, 2004 Chief Cushie Report Share Posted September 30, 2004 http://story.news.yahoo.com/news?tmpl=stor...health_merck_dc Merck Pulls Arthritis Drug from Market By Ransdell Pierson NEW YORK (Reuters) - Merck & Co Inc. on Thursday pulled its arthritis drug Vioxx off the market because it increases the risk of heart attack and stroke, a move that sent the company's shares plunging, erasing $25 billion of its market value. Vioxx, used by two million people around the world, accounts for 10 percent of Merck's annual sales. The withdrawal of the drug casts a cloud over an entire class of widely used arthritis and pain drugs known as COX-2 inhibitors. "This has implications for all members of this class," said Dr. Garret FitzGerald, chairman of the Department of Pharmacology at the University of Pennsylvania. Merck said that in a colon cancer trial, patients who took Vioxx for three years faced twice the risk of cardiovascular events, such as heart attack and stroke, as patients taking a placebo. "Patients who are currently taking Vioxx should contact their health care providers to discuss discontinuing use of Vioxx and possible alternative treatments," it said. Concerns over the drug's side effects have been building in recent years after several studies showed risks attached to it. Other drugs in the same class, including Pfizer Inc.'s Celebrex and Bextra and Novartis AG's Prexige, have so far not shown the same dangers. However, the U.S. Food and Drug Administration (news - web sites) said it would closely watch other such drugs. Worldwide sales of Vioxx totaled $2.55 billion last year. Since its introduction in 1999, 84 million people have used the medication. In the United States alone, 91 million Vioxx prescriptions have been written. The drug is sold in some countries under the name Ceoxx. "This is a very significant negative for Merck. Not only is this a nearly $3 billion drug, but it calls into question the future of one the key drugs in its pipeline, Arcoxia," said Scott Henry, an analyst at Oppenheimer & Co. Arcoxia, which is similar to Vioxx, is sold outside the United States but has not yet been approved by the FDA (news - web sites) because of concerns about heart and stroke risk. Some analysts had expected the agency to rule on Arcoxia by late October. Merck is already struggling with slowing earnings growth and faces the loss of patent protection for its biggest-selling drug, cholesterol fighter Zocor, in 2006. Despite the setback, Merck Chairman and Chief Executive Raymond Gilmartin said he had no intention of resigning. 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. Merck shares fell 25 percent on the New York Stock Exchange (news - web sites). Shares of Pfizer, which sells two rival arthritis drugs, edged higher. 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 U.S. Food and Drug Administration suggested patients taking Vioxx faced a 50 percent greater risk of heart attack and sudden cardiac death than those taking Celebrex. Sales of the Pfizer drugs Celebrex and Bextra have steadily grown as doctors have turned to those medications, 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 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 expects the cost associated with the recall to reduce earnings by 50 cents to 60 cents per share in the second half of the year, and will give more financial details on Oct. 21. Merck said it planned to cut costs and said it remains comfortable with its earnings forecast for full-year 2004 of $3.11 to $3.17 per share. Vioxx and the two Pfizer arthritis drugs are designed to block inflammation and pain as effectively as standard nonsteroidal anti-inflammatory drugs such as aspirin and ibuprofen, while causing far fewer ulcers and gastrointestinal problems than the older treatments. The newer medicines block a protein called COX-2 that has been linked to inflammation. Merck said it would continue to market Arcoxia, which is sold in 47 countries. (Additional reporting by Toni Clarke and Edward Tobin) Quote Link to comment Share on other sites More sharing options...
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