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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)

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Guest bullterrier

I was on vioxx back in may/jun of 2002. Ended up in the hospital with a perforated ulcer. :D

The surgeon I saw after said he didn't like vioxx, lots of problems.

Haven't touched it or any other nsaids since.



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  • Chief Cushie

Merck Should Have Pulled Vioxx in 2000-Study

2 hours, 17 minutes ago Health - Reuters


By Tom Armitage


BERNE (Reuters) - U.S. drugs giant Merck & Co Inc. should have pulled its Vioxx painkiller from the market four years ago because data showing it raised the risk of heart attacks has existed since 2000, Swiss scientists said on Friday.


In a report for British medical journal The Lancet, researchers at the University of Berne said there was substantial evidence of the dangerous side effects of the drug by the end of 2000, but the mounting data was not analyzed properly.


"Our findings indicate that rofecoxib (Vioxx) should have been withdrawn several years earlier," the scientists said.


Merck did not recall Vioxx, a COX-2 inhibitor taken by about 20 million Americans, from the worldwide market until five weeks ago.


Merck said in a statement it "was vigilant in monitoring and disclosing the cardiovascular safety of Vioxx and we absolutely disagree with any implication to the contrary." The company said it also disagrees with the conclusion that the drug should have been withdrawn several years ago.


"The company could and should have made the statement several years back, when the data we analyzed were readily available," Matthias Egger, a professor at the university's department for Social and Preventative Medicine, told a news conference.


Merck said the data contained in the Swiss analysis are not new and are essentially consistent with combined analyzes of clinical trials that the company had previously published.


The Swiss research follows newspaper reports earlier this week that Merck had tried to fight mounting concerns about the drug's safety in order to protect sales.


The U.S. Food and Drug Administration recently published a study estimating that Vioxx could have caused about 28,000 heart attacks or deaths since it was approved in 1999.


Merck's shares have slumped around 40 percent since the recall, and analysts estimate that it could face a bill of between $10 billion and $15 billion in litigation.




The Swiss scientists performed a meta-analysis on the data, taking in results from past studies, some of which were available on the FDA Web site. They found that patients who took Vioxx were at greater risk even after a few months, regardless of how much of the drug was taken.


Using 18 randomized controlled trials and 11 observational studies, researchers saw that heart-attack risk more than doubled when Vioxx was taken.


By the end of 2000, 52 heart attacks had occurred in 20,742 patients, the researchers said. Of these, 41 were patients using Vioxx. The increased heart-attack risks became apparent in studies that were evaluated by external watchdogs.


"It could be that without independent evaluation of the data, the assessment of adverse effects is biased so that the risks of a drug appear smaller," Egger said.


"We therefore recommend that all studies be carried out with independent external data evaluation."


Drug licensing authorities should review their procedures, the study concluded, to ensure that data released after the drug launch is analyzed for signs of side effects.


The authors also said an independent panel of experts should investigate why manufacturers and licensing authorities did not evaluate the data available on Vioxx sooner.


In an editorial in the journal, editor Richard Horton criticized both Merck and the FDA, saying they acted out of "ruthless, short-sighted, and irresponsible self interest."


"The licensing of Vioxx and its continued use in the face of unambiguous evidence of harm have been public-health catastrophes," said Horton.


"This controversy will not end with the drug's withdrawal."


Shares of Merck closed down 3 percent at $27.02 on the New York Stock Exchange on Thursday.


The study was part of a wider investigation into anti-inflammatory drugs and their side effects conducted by the University of Berne on behalf of the Swiss National Science Foundation. Full results are due mid-2006. (Additional reporting by Deena Beasley in Los Angeles)

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Yes, it is bad for you...


AND for those of you suffering with edema, it puts more stress on your kidney's to take over the counter meds like ibuprofen, etc. Most good kidney doctors will ask you to stay away from any over the counter anti-inflamitory drugs too. I know in my experience that they would swell up. Also like bullterrier mentioned they are very hard on your stomach and sometimes you DON'T feel it, only when it is too late and you end up with an ulcer...


If you MUST take something, try regular aspirin, BUT you must have something ON YOUR stomach. I know there are various "candy coated" types and also some that you can get from your doctor. AGAIN TAKE food with them. AND like all things moderation, moderation, moderation. NSAIDS - (Non steroid anti-inflamitory drugs) tend to be very hard on your kidneys whether they are in perscription form or over the counter, it is all the same.




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