# Vioxx Recalled



## M&M (Jan 20, 2002)

I don't know if any of you take Vioxx, but I do, and just in case, I wanted you all to know that it has been recalled.


> quoteress Release Source: Merck & Co., Inc.Merck Announces Voluntary Worldwide Withdrawal of VIOXX-R-Thursday September 30, 8:15 am ETWHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Sept. 30, 2004--Merck &. Co.,Inc. today announced a voluntary worldwide withdrawal of VIOXXï¿½(rofecoxib), its arthritis and acute pain medication. The company'sdecision, which is effective immediately, is based on new, three-year datafrom a prospective, randomized, placebo-controlled clinical trial, theAPPROVe (Adenomatous Polyp Prevention on VIOXX) trial.The trial, which is being stopped, was designed to evaluate the efficacy ofVIOXX 25 mg in preventing recurrence of colorectal polyps in patients witha history of colorectal adenomas. In this study, there was an increasedrelative risk for confirmed cardiovascular events, such as heart attack andstroke, beginning after 18 months of treatment in the patients taking VIOXXcompared to those taking placebo. The results for the first 18 months ofthe APPROVe study did not show any increased risk of confirmedcardiovascular events on VIOXX, and in this respect, are similar to theresults of two placebo-controlled studies described in the current U.S.labeling for VIOXX."We are taking this action because we believe it best serves the interestsof patients," said Raymond V. Gilmartin, chairman, president and chiefexecutive officer of Merck. "Although we believe it would have beenpossible to continue to market VIOXX with labeling that would incorporatethese new data, given the availability of alternative therapies, and thequestions raised by the data, we concluded that a voluntary withdrawal isthe responsible course to take."APPROVe was a multi-center, randomized, placebo-controlled, double-blindstudy to determine the effect of 156 weeks (three years) of treatment withVIOXX on the recurrence of neoplastic polyps of the large bowel in patientswith a history of colorectal adenoma. The trial enrolled 2,600 patients andcompared VIOXX 25 mg to placebo. The trial began enrollment in 2000.VIOXX was launched in the United States in 1999 and has been marketed inmore than 80 countries. In some countries, the product is marketed underthe trademark CEOXX. Worldwide sales of VIOXX in 2003 were $2.5 billion.Results of the VIGOR (VIOXX Gastrointestinal Outcomes Research) study,released in March 2000, demonstrated that the risk of gastrointestinaltoxicity with VIOXX was less than with naproxen, but indicated an increasedrisk of cardiovascular events versus naproxen. However, in other studiesincluding Merck's Phase III studies that were the basis of regulatoryapproval of the product, there was not an increased risk of cardiovascularevents with VIOXX compared with placebo or VIOXX compared with othernon-naproxen non-steroidal anti-inflammatory drugs (NSAIDs). Merck beganlong-term randomized clinical trials to provide an even more comprehensivepicture of the cardiovascular safety profile of VIOXX."Merck has always believed that prospective, randomized, controlledclinical trials are the best way to evaluate the safety of medicines.APPROVe is precisely this type of study - and it has provided us with newdata on the cardiovascular profile of VIOXX," said Peter S. Kim, Ph.D.,president of Merck Research Laboratories. "While the cause of these resultsis uncertain at this time, they suggest an increased risk of confirmedcardiovascular events beginning after 18 months of continuous therapy.While we recognize that VIOXX benefited many patients, we believe thisaction is appropriate."Merck has informed the U.S. Food and Drug Administration and regulatoryauthorities in other countries of its decision. The company also is in theprocess of notifying health care practitioners in the United States andother countries where VIOXX is marketed. Patients who are currently takingVIOXX should contact their health care providers to discuss discontinuinguse of VIOXX and possible alternative treatments. In addition, patients andhealth care professionals may obtain information from<http://www.merck.com>www.merck.com and<http://www.vioxx.com>www.vioxx.com, or may call (888) 36-VIOXX(1-888-368-4699).The results of clinical studies with one molecule in a given class are notnecessarily applicable to others in the class. Therefore, the clinicalsignificance of the APPROVe trial, if any, for the long-term use of otherdrugs in this class, consisting of COX-2 specific inhibitors and NSAIDs, isunknown. The company will work with regulatory authorities in the 47countries where ARCOXIA is approved to assess whether changes to theprescribing information for this class of drugs, including ARCOXIA, arewarranted. Merck is continuing to seek approval for ARCOXIA in othercountries, including the United States.Merck will continue its extensive clinical program to collect additionallonger-term data for ARCOXIA, its medication for arthritis and acute pain.With regard to financial guidance, prior to today's announcement, Merckremained comfortable with its 2004 earnings per share guidance of $3.11 to$3.17. The company currently expects earnings per share to be negativelyaffected by $0.50 to $0.60 as a result of today's announcement. Thisestimate includes foregone sales, writeoffs of inventory held by Merck,customer returns of product previously sold and costs to undertake thepullback of the product. Included in this cost estimate is the expectationof foregone fourth quarter sales of VIOXX of $700 million to $750 million.In addition, Merck expects that worldwide approximately one month ofinventory is held by customers and will be returned.At this point it is uncertain which of these costs will be recorded in thethird quarter and which will be recorded in the fourth quarter. Therefore,at this point, Merck is retracting the third quarter guidance it hadpreviously provided.Merck will report third-quarter earnings on Oct. 21. At that point, thecompany will provide additional information regarding the costs for productwithdrawal.About MerckMerck & Co., Inc. is a global research-driven pharmaceutical company. Merckdiscovers, develops, manufactures and markets a broad range of innovativeproducts to improve human and animal health, directly and through its jointventures.Forward Looking StatementThis press release contains "forward-looking statements" as that term isdefined in the Private Securities Litigation Reform Act of 1995. Thesestatements involve risks and uncertainties, which may cause results todiffer materially from those set forth in the statements. Theforward-looking statements may include statements regarding productdevelopment, product potential or financial performance. No forward-lookingstatement can be guaranteed, and actual results may differ materially fromthose projected. Merck undertakes no obligation to publicly update anyforward-looking statement, whether as a result of new information, futureevents, or otherwise. Forward-looking statements in this press releaseshould be evaluated together with the many uncertainties that affectMerck's business, particularly those mentioned in the cautionary statementsin Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2003, and in itsperiodic reports on Form 10-Q and Form 8-K (if any), which the companyincorporates by reference.VIOXXï¿½ (rofecoxib) is a registered trademark of Merck & Co., Inc.


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## hyenaDEN5 (Sep 3, 2004)

that's the only thing thus far that has helped with my monthly intense pain woes...


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## M&M (Jan 20, 2002)

That's exactly why I took it also, and was the only thing so far that had helped me too.Let me know if you call your doc and find something else that works! Of course, I'll do the same.Fingers crossed for both of us, and anyone else in the same boat.


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## gownowoften (Dec 5, 2003)

Edit from Moderator:There will be no more posts about your product in this forum.If you want to post information about your product, do so in the "Product Forum". This is a support forum for very ill people. Consider yourself officially warned.


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## M&M (Jan 20, 2002)

IBSsucks,Just wanted to let you know that my doctor called in a script for Bextra today, to replace my Vioxx.It's in the same class of drugs (Cox 2 inhibitors), and the nurse said they've had good results with Bextra in women with cramps.


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## moldie (Sep 25, 1999)

Mrs M. what the heck was that about? Is gonowoften a troll?


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## M&M (Jan 20, 2002)

Hi M!Gonowoften is an over zealous sales person. S/He sells a product, and instead of posting his/her commercial sales pitch in the Products forum as directed, s/he insists on posting it willy nilly all over the BB.The sad thing is, Gonowoften has been talked to repeatedly about this. It's an issue Susan dealt with on many different occasions. I hope s/he will post information about their product in the correct forum. That way all of you can check it out if you care to, and make your own informed decision!


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## moldie (Sep 25, 1999)

Thanks for clearing that up Mrs.M!


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