Guest guest Posted January 18, 2001 Report Share Posted January 18, 2001 Sharon wrote: > > Georgina, One of the posts reads about deaths attributed to Vioxx. > Do you have any information regarding this. I'm concerned for all > our JRA kids, there are so many on Vioxx----including my two. I > wonder if the Vioxx has contributed to the colon problems is > having. The side effects of the medicines can be as wicked as the > disease. Thanks, Sharon B. Hi Sharon, These are the news item I found about the Vioxx scare. I think this may be what you were thinking of. The rate of reported adverse reactions is approximately one per 500 prescriptions. " Gastrointestinal adverse reactions account for almost half (554) of the reports, of which the majority (84%) were nausea, dyspepsia, diarrhoea and abdominal pain, " the agency said. " However there have been 68 reports (12%) of upper GI perforations, ulceration and bleeds (PUBs). Forty-four (65%) of the patients with PUBs recovered, although five had a fatal outcome. " It is a little scary ... Take care, Georgina Eleven Deaths Among UK Vioxx Users http://arthritis.about.com/health/arthritis/gi/dynamic/offsite.htm?site=http%3A%\ 2F%2Frheumatology.medscape.com%2Freuters%2Fprof%2F2000%2F09%2F09.08%2F20000908rg\ lt007.html LONDON, Sep 08 (Reuters Health) - Eleven deaths and more than 1,000 reports of suspected adverse reactions to Merck's new osteoarthritis drug Vioxx (rofecoxib) have been reported in the UK since its launch in June last year, British regulators said on Thursday. The Medicines Control Agency (MCA) and the Committee on Safety of Medicines (CSM) said, " Up to July 2000, the MCA/CSM had received a total of 1,120 reports, via the Yellow Card Scheme, of suspected adverse reactions to rofecoxib. " Five patients died following gastrointestinal reactions, three following cardiac failure and three following myocardial infarction, the agencies reported in their newsletter " Current Problems. " An estimated 557,100 prescriptions for Merck's COX-2 inhibitor have been dispensed in the UK up to the end of May 2000, the agencies said. The rate of reported adverse reactions is therefore approximately one per 500 prescriptions. " Gastrointestinal adverse reactions account for almost half (554) of the reports, of which the majority (84%) were nausea, dyspepsia, diarrhoea and abdominal pain, " the agency said. " However there have been 68 reports (12%) of upper GI perforations, ulceration and bleeds (PUBs). Forty-four (65%) of the patients with PUBs recovered, although five had a fatal outcome. " The agencies also received 177 reports of suspected cardiovascular reactions, including 101 reports of oedema, 31 reports of hypertension and 19 reports of palpitations. There were 15 reports of cardiac failure, three of which had a fatal outcome, and nine reports of myocardial infarction, three of them fatal. In the majority of these cases, the patient had risk factors for cardiovascular disease. Psychiatric reactions were also reported, including 28 reports of depression, 14 reports of confusion and 11 reports of hallucinations. Adverse reactions recognised with other NSAIDs were also reported with rofecoxib. These included angioedema (35 reports), bronchospasm or exacerbation of asthma (25), renal failure (16), and abnormal hepatic function (12). The newsletter reminded prescribers that rofecoxib is contraindicated in patients with active peptic ulceration, GI bleeding, and severe congestive heart failure. It also noted that " caution should be exercised in patients with a history of cardiac failure, left ventricular dysfunction, or hypertension and in patients with pre-existing oedema for any other reason " . In conclusion, the agencies said, " As with all new drugs, the safety of rofecoxib remains under close review. " They pointed out that another COX-2 inhibitor, Pharmacia's celecoxib (Celebrex), had been launched recently and promised to report on its safety profile in a forthcoming bulletin. Merck officials were not immediately available for comment. -------------------------------------------------------------- Agencies' VIOXX Findings Mirror Clinical Studies of the Drug http://arthritis.about.com/health/arthritis/gi/dynamic/offsite.htm?site=http%3A%\ 2F%2Frheumatology.medscape.com%2Freuters%2Fprof%2F2000%2F09%2F09.11%2F20000911in\ ds009.html LONDON, Sep 11 (Reuters Health) - Following reports that its osteoarthritis drug VIOXX (rofecoxib) is responsible for 11 deaths in the UK, Merck insisted on Friday that the drug has an excellent safety profile and that the risk of adverse reactions is far less than with traditional nonsteroidal anti-inflammatory drugs (NSAIDS). On Thursday, the UK's Medicines Control Agency (MCA) and the Committee on Safety of Medicines (CSM) said in their newsletter that five patients died following gastrointestinal reactions, three following cardiac failure and three following myocardial infarction. The groups also reported that up to July 2000, they had received " a total of 1,120 reports, via the Yellow Card Scheme, of suspected adverse reactions to rofecoxib. " In a statement released on Friday, Merck's UK subsidiary said that the results of the MCA/CSM review " mirror the findings of the clinical trials rofecoxib has undergone to confirm its safety profile in everyday clinical practice. " " On the basis of data published in the MCA report, an estimate of 0.068% of patients receiving VIOXX were reported as having PUBs [perforations, ulceration and bleeds]. Whilst it is acknowledged that there is under-reporting of adverse events, this is considerably lower than the level of background incidence of non-NSAID users in the general population, " the statement said. The statement goes on to say that the " estimated incidence for GI [gastrointestinal] hospital admissions in the general population (i.e., background incidence) is 0.8% to 1.4%, and is increased to 1.9% to 2.0% in those patients receiving NSAIDs. " Furthermore, in a study of 8,000 patients, rofecoxib significantly reduced the risk of serious GI events by 54%, compared to naproxen, an NSAID, the subsidiary said. " Similarly, " the statement says, " the percentage of cardiovascular ADRs [adverse drug reactions] published in the MCA report is of the same low percentage as expected. Rates of lower extremity oedema in clinical trials in osteoarthritis were similar for rofecoxib and ibuprofen and diclofenac [both NSAIDs] at about 3.5% to 4%. The incidence of MI with rofecoxib was 0.6%, whereas the placebo group was 1.4%. " " Further confidence in the safety profile of rofecoxib can be drawn from the patient profile of rofecoxib users. An analysis of prescribing trends shows that 72% of patients receiving rofecoxib are older than 65 years and/or have a past history of gastric disorders, and/or significant co-morbidity, " the statement says. " While rofecoxib is not specifically indicated for patients at high risk of GI events, it would appear that GPs are demonstrating confidence in the drug by using rofecoxib successfully in this group. " " The MCA report of rofecoxib is a welcome review 1 year from launch, and is consistent with the excellent safety profile of rofecoxib, " the statement concluded. An estimated 557,100 prescriptions for the drug, which is a COX-2 inhibitor, have been dispensed in the UK up to the end of May 2000, the MCA and CSM said. The rate of reported adverse reactions is therefore approximately one per 500 prescriptions. Copyright © 2000 Reuters Ltd. ----------------------------------------------------------------- Title: Cardiovascular safety profile of Vioxx (rofecoxib) confirmed URL: http://www.pslgroup.com/dg/1CF066.htm WEST POINT, PA -- May 1, 2000 -- In response to speculative news reports, Merck & Co., Inc. confirmed the favorable cardiovascular safety profile of Vioxx® (rofecoxib), its medicine that selectively inhibits COX-2. Vioxx was approved by the U.S. Food and Drug Administration in May 1999 for the management of osteoarthritis and the relief of acute pain in adults based on efficacy and safety studies involving nearly 4,000 patients. Extensive review of data from the completed osteoarthritis trials and on- going clinical trials with Vioxx, as well as post-marketing experience with Vioxx, have shown NO DIFFERENCE in the incidence of cardiovascular events, such as heart attack, among patients taking Vioxx, other NSAIDs and placebo. More than 10 million prescriptions have been written for Vioxx in the United States since its introduction. In preliminary findings from Merck's large gastrointestinal (GI) outcomes study that compared Vioxx with naproxen in patients with rheumatoid arthritis, significantly fewer heart attacks were observed in patients taking naproxen (0.1 percent) compared to patients taking Vioxx (0.5 percent). This result is consistent with naproxen's ability to block platelet aggregation. This is the first time this effect of naproxen to reduce these events has been demonstrated in a clinical study. Vioxx, like all COX-2 selective medicines, does not block platelet aggregation and therefore would not be expected to have these effects in reducing these events. In a separate GI outcomes study in osteoarthritis and rheumatoid arthritis patients, celecoxib, another agent that selectively inhibits COX-2, was compared to NSAIDs diclofenac and ibuprofen. Pharmacia, maker of celecoxib, has indicated that there were no differences among celecoxib, ibuprofen and diclofenac on these cardiovascular events. In reports, the incidence of patients taking celecoxib who experienced a heart attack was cited as 0.5 percent, 0.3 percent among diclofenac patients, and 0.5 percent among patients taking ibuprofen. Further analyses are ongoing, and final results of the GI outcomes study with Vioxx will be presented at the Digestive Disease Week meeting on May 24, 2000. The recommended dose of Vioxx for the treatment of osteoarthritis is 12.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 25 mg once daily. Serious stomach problems, such as bleeding, can occur without warning symptoms. Administration of low-dose aspirin with Vioxx may result in an increased rate of GI ulcers or other complications compared to use of Vioxx alone. Physicians and patients should remain alert for signs and symptoms of gastrointestinal bleeding. Common side effects reported in osteoarthritis clinical trials with Vioxx were upper-respiratory infection, diarrhea, nausea and high blood pressure. People who have had an allergic reaction to Vioxx, aspirin or other NSAIDs should not take Vioxx. Safety and effectiveness in children below the age of 18 have not been studied. Merck & Co., Inc. is a global, research-driven pharmaceutical company that discovers, develops, manufactures and markets a broad range of human and animal health products, directly and through its joint ventures, and provides pharmaceutical benefit services through Merck-Medco Managed Care. http://www.pslgroup.com/dg/Vioxx.htm http://www.pslgroup.com/dg/Merck.htm Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 15, 2003 Report Share Posted February 15, 2003 Hi everyone, how are you all doing? I just wish that the weather would clear up. And maybe I would feel better. Well, I had been taking vioxx for about 3 weeks and was doing a lot better then it all stop. I started hurting again. I have a Dr. appointment on the 19 maybe he can help out some. Well, just wanted to stop by and tell all about vioxx that I had been taking. Take care, PS Hi Mark, I do hope that your up coming surgery will turn out ok. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 4, 2003 Report Share Posted December 4, 2003 Hi, I so agree with you, Becki. If my son hadn't been treated aggressively enough, there's no telling what might have happened. I know, for certain, that he wouldn't be as well as he is now. It helped me tremendously, as far as my personal feelings about giving him Methotrexate, to learn that the amounts used in the treatment of rheumatic diseases are literally hundreds to thousands times less than the dosage amounts typically used for treatment of cancers. I was still concerned, of course, but the side effects were so mild compared to the benefits he received from it. JRA, especially systemic JRA, can be a very hard-hitting, nasty, disease. I'd rather face it head on and treat it with strong, well-studied, proven-effective medicines that can help prevent the sometimes life-threatening complications, not only joint deformity, which is generally associated with JRA, than to have regrets later that I didn't do something which might have been in my child's best interests. I can see where others might not come to the same conclusion, though, because every case is different. 's arthritis was very severe. We had to hurry up and begin a strong treatment regimen or he might very well have died. I might think very differently about things if his arthritis was mild or only moderate, where the worst consequence might have been a slight disability where he'd lose functional use of a few joints. When your child is at high risk and has involvement of important organs, you tend to react a bit quicker. Because you have to. Aloha, Georgina Arthurnator@... wrote: > Hi, > Vioxx is being studied on children at Cincinatti Childrens pediatric > rheumatoligy department and no telling how many other places.It's just a > matter of time before it's approved for children.MTX isn't approved and > it's been used for many,many years.Just the way things are.The FDA's > pediatric rule for drugs is changing things but it's still a slow > process.The Nap is a very hard NSAID.I wouldn't let be put on > it.Too hard on the tummy and causes fragile skin which can lead to > permanant scarring.Hopefully the Vioxx alone will help Nick but systemic > disease is very serious and needs to be treated as such.The effects of > the medicine are no where near as bad as the irreversable joint damage > that can be caused by the JRA.I can tell you that all of us moms and > dads freaked out when reading up on MTX.It sounds like such a poison but > most people suffer no ill effects from it.I can remember crying every > time I read the patiant insert but several months later if someone > wanted to take off of it they would have to kill me.Not a single > side effect in over 2 yrs and was put on 25mg when he was 3 yrs > old.Most adult rheumies do not like to go higher then 20mg.Try not to > let the drugs scare you.They do much more good then harm.You just have > to make sure you comply with the lab work so any serious problems can be > detected before any symptoms are noticable. > Hugs > Becki and 5systemic Quote Link to comment Share on other sites More sharing options...
Guest guest Posted January 22, 2004 Report Share Posted January 22, 2004 As an adult JRA sufferer, I had one of the little seen side effects of Laryngitis. For about two months I could speak very little. Saw my doc several time and she could mot find a problem. Took a close look at the Vioxx package insert and saw it mentioned. After stopping the Vioxx I was fine with a few days. > Just a quick question for those of you who have had children - or > even yourselves - on Vioxx. Blaise, 12, is insisting that it > makes him " tired " . He says the 2 or 3 times that he missed a dose he > felt he had more energy - more stiffness, but also more pain. This > makes little sense to me, but I was wondering if anyone else had > experienced the same. Thanks, G Quote Link to comment Share on other sites More sharing options...
Guest guest Posted October 2, 2004 Report Share Posted October 2, 2004 NATAP - www.natap.orgMerck's Vioxx-A Widely Used Arthritis Drug Is WithdrawnBy GINA KOLATANY Times, Oct 1, 2004The drug company Merck announced yesterday that it would stop selling its arthritis and pain medication Vioxx, currently taken by close to two million people worldwide, because a new study found that it doubled patients' risk of heart attack and strokes.Vioxx has been a blockbuster for Merck, with sales of $2.5 billion last year, and has been widely marketed as a safe alternative to drugs like aspirin, which can cause ulcers and gastrointestinal bleeding.The decision to remove the drug from the market, the largest drug recall in history as measured by sales, comes as Merck has been struggling to find new drugs for its aging product line. Vioxx represented about 11 percent of the company's revenue last year. Merck stock plunged 27 percent yesterday on the news, reducing the company's stock market value by $25 billion and helping pull the Dow industrial average down by 0.6 percent for the day.The company decided to withdraw the drug from pharmacy shelves after a study that it had hoped would show that Vioxx prevented colon polyps, which can sometimes become cancerous. Merck quickly ended the trial after the results of the study showed last week that the drug led to heart attacks and strokes.The risk was small - 15 cases of heart attack, stroke or blood clots per thousand people over three years compared with 7.5 such events per thousand patients taking a placebo. But the data were so unambiguous that Merck told federal regulators this week that it had halted the trial and would take the drug off the market; it announced that decision yesterday."What we found in this study is that beginning after 18 months, there was a discernible and unexpected increase in cardiovascular disease rates," Dr. S. Kim, president of Merck Research Labs, said in an interview yesterday. There had been hints before that the drug might increase the risk of heart attacks and strokes, but the studies were not definitive and the company said it had not been convinced that the risk was real, although it did revise the drug's label two years ago to include that possibility. This time was different."What we saw was stunning," Dr. Kim said. "We certainly don't understand the cause of this effect, but it is statistically significant and it indicated that there is an issue."Dr. Kim said the decision came on Monday, after a series of urgent teleconferences with medical experts over the weekend. On Tuesday, company officials went to the Food and Drug Administration and said it was withdrawing the drug. The decision was the company's alone, and there was no pressure from the F.D.A., which said it was surprised by Merck's move but agreed with it. "We think Merck did the right thing,'' said Dr. K. Galson, the acting director of the F.D.A.'s Center for Drug Evaluation and Research.Not everyone who takes Vioxx does so for 18 months or longer. Or even daily. Some arthritis patients take it only during flare-ups. And other people might take it only for several months, after a sports injury, for example. Medical experts say that it is safe for patients to abruptly stop taking Vioxx, adding that there are many alternatives to the drug, including cheap over-the-counter drugs. One of those, aspirin, is much cheaper than Vioxx, which has sold for $2.50 or more a pill. Vioxx provides about the same pain relief as aspirin, although studies showed that patients taking Vioxx were less likely to develop ulcers or gastrointestinal bleeding.There are also two prescription drugs, Celebrex and Bextra, both made by Pfizer, which are similar to Vioxx but have not been shown to pose cardiovascular risks. That, and Pfizer's extensive advertising, may help explain why sales of Celebrex have lately been twice those for Vioxx. The F.D.A. says, however, that studies of Celebrex and Bextra have lasted only a year, and the Vioxx study found risks only after people had taken it for 18 months. Asked in a telephone news conference if the agency will start requiring longer-term studies for drugs of this class, Dr. Galson said no decision had been reached."It's too early to say right now, but obviously we will be more interested in long-term data," he replied. Dr. Kim of Merck said he first learned of the new data on heart attacks and strokes on Thursday evening last week, when he got a call from an independent committee of scientists who were monitoring the colon polyp study. "They recommended we stop the study," he said."On Friday, I looked at the data with my team," Dr. Kim said. "The first thing you do is review the data. We did that. Second is you double-check the data, go through it and make sure that everything is O.K." At that point, he said, "I knew that barring some big mistake in the analysis, we had an issue here." "Around noon, I called Ray Gilmartin and told him what was up," Dr. Kim continued, referring to Merck's chief executive. "He said, 'Figure out what was the best thing for patient safety.' We then spent Friday and the rest of the weekend going over the data and analyzing it in different ways and calling up medical experts to set up meetings where we would discuss the data and their interpretations and what to do."On Sunday night and Monday morning, Dr. Kim and his team spoke to researchers doing studies and to medical experts in rheumatology, cardiology and gastroenterology.Some, he said, told him to take the drug off the market right away. Others could not decide what recommendation to make. Rheumatologists, however, told him that there were patients who needed the drug.By late Monday morning, Dr. Kim had made his decision. "We were going to withdraw," he said.He told Mr. Gilmartin and got his agreement. On Tuesday, Merck notified its board and that afternoon the company told the F.D.A. On Wednesday, the company began notifying regulatory agencies in other countries. Yesterday morning, Merck made its public announcement.Although Mr. Kim said he was stunned by the data, others were less surprised. The possibility that Vioxx might increase the risk of heart attacks first emerged three years ago, in a Merck study of 7,000 patients with rheumatoid arthritis. The company was asking whether those taking a high dose of Vioxx, 50 milligrams a day, had fewer gastrointestinal side effects than those who were randomly assigned to take naproxen.The results showed that the Vioxx patients had half the incidence of gastrointestinal complaints, but it also indicated that they had five times the number of heart attacks - five per thousand patients as compared to one per thousand with naproxen.The question was why. It could be, as some cardiologists argued, that Vioxx caused heart attacks. Or it could be, as Merck argued, that Vioxx was neutral, while naproxen actually reduced the likelihood of a heart attack.In April 2002, at the request of the Food and Drug Administration, Merck added the study's finding about heart attack risk to the drug's label.Several other studies followed. One looked at a million Medicaid patients; another at 1.4 million patients enrolled in Kaiser Permanente's health care plans; another at more than 50,000 Medicare patients. Each found more heart attacks and strokes with Vioxx, but medical experts differed over how to interpret the data.Dr. Topol, a cardiologist at the Cleveland Clinic, writing in medical journals, argued vehemently that Vioxx and others in its class were not worth taking. He said they had "marginal efficiency, heightened risk, and excessive cost" compared with drugs like aspirin. Dr. , a rheumatologist and epidemiologist at Brigham and Women's Hospital in Boston, said yesterday that he was convinced enough by the data that he stopped prescribing Vioxx two years ago.Dr. scoffed at Merck's assertion that the new data were unexpected. "I was like, 'Please. Really,' " Dr. said.But others, including Dr. Lockshin, an arthritis specialist at the Hospital for Special Surgery in New York, were less certain. Dr. Lockshin said that, until now, "the data were quite minor" to indicate that Vioxx was causing a problem. The original study's findings had an alternative explanation, he said, and the other studies were complicated by the fact that they lacked enough rigor to make the case. The new data, however, convinced him. Even if Merck had not withdrawn the drug, he would no longer prescribe it, Dr. Lockshin said. "Although the numbers are not huge in terms of risk, these are the things that I, looking at it as a practitioner, couldn't say, 'Oh, well. This drug is as safe as another.' "He added, however, that some of his patients might have difficulty finding an alternative to Vioxx. Pain relief, he said, is idiosyncratic and unpredictable. "Some patients respond beautifully to one drug and not to another."And some patients are simply reluctant to give up a drug that worked for them.Dr. Jerry Lynn, a retired dentist who lives in Manhattan, said Vioxx was the only drug he had ever taken for his arthritic knee. "It made a big difference," he said yesterday. He still has a large supply, he said, adding, "I'll just use them until I use them up." ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ NATAP - www.natap.orgFDA Issues Public Health Advisory on Vioxx as its Manufacturer Voluntarily Withdraws the Product The Food and Drug Administration (FDA) today acknowledged the voluntary withdrawal from the market of Vioxx (chemical name rofecoxib), a non-steroidal anti-inflammatory drug (NSAID) manufactured by Merck & Co. FDA today also issued a Public Health Advisory to inform patients of this action and to advise them to consult with a physician about alternative medications. Merck is withdrawing Vioxx from the market after the data safety monitoring board overseeing a long-term study of the drug recommended that the study be halted because of an increased risk of serious cardiovascular events, including heart attacks and strokes, among study patients taking Vioxx compared to patients receiving placebo. The study was being done in patients at risk of developing recurrent colon polyps. "Merck did the right thing by promptly reporting these findings to FDA and voluntarily withdrawing the product from the market," said Acting FDA Commissioner Dr. Lester M. Crawford. "Although the risk that an individual patient would have a heart attack or stroke related to Vioxx is very small, the study that was halted suggests that, overall, patients taking the drug chronically face twice the risk of a heart attack compared to patients receiving a placebo." Dr. Crawford added that FDA will closely monitor other drugs in this class for similar side effects. "All of the NSAID drugs have risks when taken chronically, especially of gastrointestinal bleeding, but also liver and kidney toxicity. They should only be used continuously under the supervision of a physician." FDA approved Vioxx in 1999 for the reduction of pain and inflammation caused by osteoarthritis, as well as for acute pain in adults and for the treatment of menstrual pain. It was the second of a new kind of NSAID (-2 selective) approved by FDA. Subsequently, FDA approved Vioxx to treat the signs and symptoms of rheumatoid arthritis in adults and children. At the time that Vioxx and other -2 selective NSAIDs were approved, it was hoped that they would have a lower risk of gastrointestinal ulcers and bleeding than other NSAIDs (such as ibuprofen and naproxen). Vioxx is the only NSAID demonstrated to have a lower rate of these side effects. Merck contacted FDA on September 27, 2004, to request a meeting and to advise the agency that the long-term study of Vioxx in patients at increased risk of colon polyps had been halted. Merck and FDA officials met the next day, September 28, and during that meeting the company informed FDA of its decision to remove Vioxx from the market voluntarily.In June 2000, Merck submitted to FDA a safety study called VIGOR (Vioxx Gastrointestinal Outcomes Research) that found an increased risk of serious cardiovascular events, including heart attacks and strokes, in patients taking Vioxx compared to patients taking naproxen. After reviewing the results of the VIGOR study and other available data from controlled clinical trials, FDA consulted with its Arthritis Advisory Committee in February 2001 regarding the clinical interpretation of this new safety information. In April 2002, FDA implemented labeling changes to reflect the findings from the VIGOR study. The labeling changes included information about the increase in risk of cardiovascular events, including heart attack and stroke. Recently other studies in patients taking Vioxx have also suggested an increased risk of cardiovascular events. FDA was in the process of carefully reviewing these results, to determine whether further labeling changes were warranted, when Merck informed the agency of the results of the new trial and its decision to withdraw Vioxx from the market. Additional information about this withdrawal of Vioxx, as well as questions and answers for patients, is available online at http://www.fda.gov/cder/drug/infopage/vioxx/default.htm. FDA Public Health Advisory: Safety of Vioxx Merck & Co., Inc. today announced a voluntary withdrawal of Vioxx from the U.S. market due to safety concerns. Vioxx is a prescription COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) that was approved by FDA in May 1999 for the relief of the signs and symptoms of osteoarthritis, for the management of acute pain in adults, and for the treatment of menstrual symptoms. It is also approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children. The Agency was informed by Merck & Co., Inc. on September 27, 2004, that the Data Safety Monitoring Board for an ongoing long-term study of Vioxx (APPROVe) had recommended that the study be stopped early for safety reasons. The study was being conducted in patients at risk for developing recurrent colon polyps. The study showed an increased risk of cardiovascular events (including heart attack and stroke) in patients on Vioxx compared to placebo, particularly those who had been taking the drug for longer than 18 months. Based on this new safety information, Merck and FDA officials met the next day, September 28, 2004, and during that meeting FDA was informed that Merck was voluntarily withdrawing Vioxx from the market place. The risk that an individual patient taking Vioxx will suffer a heart attack or stroke related to the drug is very small. Patients who are currently taking Vioxx should contact their physician for guidance regarding discontinuation and alternative therapies. FDA is working closely with Merck to coordinate the withdrawal of this product from the U.S. market place. Healthcare professionals are advised to contact Merck at 1-888-368-4699 or at www.merck.com or at the FDA's Drug Information Office at 301-827-4573 or 1-888-463-6332 or go to Vioxx Information on FDA's website at: www.fda.gov/cder/drug/infopage/vioxx/default.gov for questions about this product. 1. What action did Merck take today? Merck announced a voluntary worldwide withdrawal of Vioxx (rofecoxib).2. What is Vioxx?Vioxx is a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID). Vioxx is also related to the nonselective NSAIDs , such as ibuprofen and naproxen. Vioxx is a prescription medicine used to relieve signs and symptoms of arthritis, acute pain in adults, and painful menstrual cycles. 3. Did FDA require this action?No, Merck made this decision independent of input from FDA. The Agency has not had an opportunity to review the data from the study that was stopped in the depth that Merck has, but agrees with the company that there appear to be significant safety concerns for patients, particularly those taking the drug chronically.FDA plans to work closely with Merck to coordinate the withdrawal of this product from the US market.4. What action did FDA take today? FDA issued a public health advisory concerning the use of Vioxx. This advisory is based on Merck & Co., Inc. voluntarily withdrawing Vioxx from the marketdue to safety concerns.5. What should I do if I am currently taking Vioxx?The risk that an individual patient will suffer a heart attack or stroke related to Vioxx is very small. We encourage people taking Vioxx to contact their physician to discuss discontinuing use of Vioxx and alternative treatments. Any decision about which drug product to take to treat your symptoms should be made in consultation with your physician based on an assessment of your specific treatment needs.6. What are the likely long-term health effects, if any, of taking this product?The new study shows that Vioxx may cause an increased risk in cardiovascular events such as heart attack and strokes during chronic use.7. What evidence supports the Public Health Advisory?Merck's decision to withdraw Vioxx from the market is based on new data from a trial called the APPROVe [ Adenomatous Polyp Prevention on VIOXX] trial. In the APPROVe trial, Vioxx was compared to placebo (sugar-pill). The purpose of the trial was to see if Vioxx 25 mg was effective in preventing the recurrence of colon polyps. This trial was stopped early because there was an increased risk for serious cardiovascular events, such as heart attacks and strokes, first observed after 18 months of continuous treatment with Vioxx compared with placebo.8. Why wasn't the APPROVe trial stopped earlier?The APPROVe trial began enrollment in 2000. The trial was being monitored by an independent data safety monitoring board (DSMB). It was not stopped earlier because the results for the first 18 months of the trial did not show any increased risk of confirmed cardiovascular events on Vioxx. 9. What did FDA know about the risk of heart attack and stroke when it approved Vioxx?FDA originally approved Vioxx in May 1999. The original safety database included approximately 5000 patients on Vioxx and did not show an increased risk of heart attack or stroke. A later study, VIGOR (VIOXX GI Outcomes Research), was primarily designed to look at the effects of Vioxx on side effects such as stomach ulcers and bleeding and was submitted to the FDA in June 2000. The study showed that patients taking Vioxx had fewer stomach ulcers and bleeding than patients taking naproxen, another NSAID, however, the study also showed a greater number of heart attacks in patients taking Vioxx. The VIGOR study was discussed at a February 2001 Arthritis Advisory Committee and the new safety information from this study was added to the labeling for Vioxx in April 2002. Merck then began to conduct longer-term trials to obtain more data on the risk for heart attack and stroke with chronic use of Vioxx.10. Is FDA's expedited review process putting riskier drugs on the market? No. Vioxx received a six-month priority review because the drug potentially provided a significant therapeutic advantage over existing approved drugs due to fewer gastrointestinal side effects, including bleeding. A product undergoing a priority review is held to the same rigorous standards for safety, efficacy, and quality that FDA expects from all drugs submitted for approval. 11. What other drugs are similar to Vioxx?Vioxx is a COX-2 selective, nonsteroidal anti-inflammatory drug (NSAID). Other COX-2 selective NSAIDs on the market at this time are Celebrex (celecoxib) and Bextra (valdecoxib). Vioxx is also related to the nonselective NSAIDs, such as ibuprofen and naproxen. You should consult your physician to determine which treatment is right for you. 12. Does today's action suggest that other drugs in the same class are dangerous?The results of clinical studies with one drug in a given class do not necessarily apply to other drugs in the same class. All of the NSAIDs have risks when taken chronically, especially of gastrointestinal (stomach) bleeding, but also liver and kidney toxicity. Patients using these drugs for a long period of time (longer than two weeks) should be under the care of a physician. 13. Will Vioxx be recalled?FDA did not request a recall of Vioxx. This product is being voluntarily withdrawn from the market by Merck.14. Can my pharmacist continue to fill my prescription for Vioxx?No, Merck is initiating a market withdrawal in the United States to the pharmacy level. This means Vioxx will no longer be available at pharmacies.15. How can I report a serious side effect with Vioxx to FDA?FDA encourages anyone aware of a serious adverse reaction to make a MedWatch report. You can report an adverse event in two ways:* Visit www.fda.gov/medwatch and click on "How to Report" * Call 1-800-FDA-1088 16. Where can I get more information?You can obtain more information from Merck at:* www.merck.com and www.vioxx.com , or* 1-888-36VIOXX (1-888-368-4699) To find out more about Vioxx from FDA:* Visit our Drug Information web page at: www.fda.gov/cder* Call Drug Information at: 888-INFO-FDA (888-463-6332) ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ Vioxx, Other "Super Aspirins" Are Super Disasters - Other -2 Alternatives Have Safety Problems Too Statement by Sidney M. Wolfe, MD, Director of Public Citizen's Health Research Group, Concerning Withdrawal of Vioxx From the Market Today's announcement by Merck is the latest evidence that this family of drugs, the -2 inhibitors, once referred to as "super aspirins," are turning out to be more like super disasters. In an article published three and a half years ago in our monthly newsletter, Worst Pills, Best Pills News (now online at http://www.WorstPills.org/vioxxqd/ ), we warned readers that both Vioxx and Celebrex were DO NOT USE drugs - our designation for drugs that are not safe and effective enough to use. Although Merck's withdrawal of Vioxx "solves" the serious safety problems with this drug, the most-prescribed alternatives, Celebrex and Bextra, also have some concerns about their cardiac toxicity. If you were subscribing to WorstPills.org you would have advance warning about these and other prescription drugs. For more information on how to subscribe to this valuable online publication, follow this link: https://www.worstpills.org/subscribe.cfm?src=17 To read the complete press release, follow this link: http://www.citizen.org/publications/release.cfm?ID=7333 Quote Link to comment Share on other sites More sharing options...
Recommended Posts
Join the conversation
You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.