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  • VIOXX WITHDRAWN from market

    Sep 30, 2004

    Rofecoxib withdrawn worldwide by Merck

    Whitehouse Station, NJ - Merck has withdrawn its selective COX-2 inhibitor rofecoxib (Vioxx®) from all markets worldwide, following the availability of new three-year data from the Adenomatous Polyp Prevention on VIOXX (APPROVE) trial showing an increased risk of cardiovascular events with the drug.


    Rofecoxib was launched in 1999 for the treatment of arthritis and had worldwide sales last year of $2.5 billion. Merck's share price plunged on the announcement.

    Multiple other studies have also suggested an increased cardiovascular risk with rofecoxib, but until now Merck has denied there was any safety issue with the drug, and the APPROVE study was conducted in part to ascertain more information on this.


    The APPROVE trial, which is being stopped, was testing rofecoxib 25 mg vs placebo in the prevention of the recurrence of colorectal polyps in 2600 patients with a history of colorectal adenoma. The study showed an increased relative risk for MI and stroke with rofecoxib, which became evident after 18 months of treatment.


    Raymond V Gilmartin, chair, president, and chief executive officer of Merck, said: "We are taking this action because we believe it best serves the interests of patients. Although we believe it would have been possible to continue to market Vioxx with labeling that would incorporate these new data, given the availability of alternative therapies and the questions raised by the data, we concluded that a voluntary withdrawal is the responsible course to take."


    The APPROVE trial was started in 2000, following the results of the VIOXX Gastrointestinal Outcomes Research (VIGOR) study, which indicated an increased risk of cardiovascular events with rofecoxib vs naproxen. Merck argued that naproxen was exerting a protective cardiovascular effect and rofecoxib did not have a cardiac safety issue, which it claimed was supported by phase 3 studies in which no increased risk of cardiovascular events with rofecoxib were seen vs placebo or other non-naproxen NSAIDs.


    Peter Kim (president of Merck Research Laboratories) said: "Merck has always believed that prospective, randomized, controlled clinical trials are the best way to evaluate the safety of medicines. APPROVE is precisely this type of studyand it has provided us with new data on the cardiovascular profile of Vioxx. While the cause of these results is uncertain at this time, they suggest an increased risk of confirmed cardiovascular events beginning after 18 months of continuous therapy."


    What about the other coxibs?

    While the other selective COX-2 inhibitors, such as celecoxib (Celebrex®, Pfizer) will now come under close scrutiny, they are not believed to have such a negative cardiovascular profile as rofecoxib. Merck has a second selective COX-2 inhibitor, etoricoxib (Arcoxia®), which is available in 47 countries, and the company says that the cardiovascular safety issue with rofecoxib is not necessarily applicable to others in the class but will work with regulatory authorities to assess whether changes to the prescribing information for etoricoxib is warranted. Etoricoxib is not yet available in the US, but Merck said it will continue to seek approval and will continue its clinical-trial program with this drug.


    Reaction mixed from cardiologists
    One cardiologist who has long maintained that rofecoxib had an unacceptable cardiovascular safety profile is Dr Eric Topol (Cleveland Clinic, OH). He commented to heartwire that "Merck has finally got it right," although it was "too bad it took so long for them to accept the truth." He added: "Ironically, the validation of our concern came from a colon polyp trial in patients without any known heart disease." He said the other COX-2 inhibitors seemed safer, but "it was hard to know."


    Another high-profile cardiologist is not so forthright on this issue. Dr Robert Califf (Duke Clinical Research Institute, Durham, NC) commented to heartwire that rofecoxib caused a small but measurable increase in risk of cardiovascular events, but that other ongoing placebo controlled trials do not show the same effect. "From what we can piece together from the poor studies that are available, it looks like naproxen may be the only one that reduces riskwe just don't know about celecoxib, etc. Any chronically given drug that affects inflammation will have cardiovascular effects. Not doing long-term trials to inform the public about the balance of risks and benefits is like playing Russian rouletteyou just don't know which chambers have bullets unless you look."


    He added that: "It's a shame the drug has to pulled from the market. It would be best to inform doctors and patients of the risk and let them make a choice, but because of the dominance of lawsuits in therapeutics, obviously Merck can't afford to do that."






    Related links

    1. ACR issues alert on cardiovascular complications of COX-2 inhibitors [HeartWire > News; Sep 28, 2004 ]
    2. FDA-funded study shows rofecoxib doses >25 mg/day triple risk of acute MI and sudden cardiac death [HeartWire > News; Aug 26, 2004 ]
    3. Largest coxib trial ever stirs more debate [HeartWire > News; Aug 19, 2004 ]
    4. Rofecoxib increases risk of edema, loss of hypertension control, but not celecoxib or NSAIDs [HeartWire > Hypertension; Jun 24, 2004 ]
    5. Rofecoxib, NSAIDs linked to higher CHF hospitalization rates [HeartWire > Heart failure; May 27, 2004 ]
    6. Rofecoxib increases MI risk, latest study published [HeartWire > News; Apr 21, 2004 ]
    7. Rofecoxib increases CV events in arthritis patients with high BP [HeartWire > Hypertension; Mar 18, 2004 ]
    8. Pharmacologist wins legal battle with Merck over rofecoxib article [HeartWire > News; Feb 4, 2004 ]
    9. More cardiovascular data on etoricoxib [HeartWire > News; Dec 17, 2003 ]
    10. COX-2 inhibitors: No thrombotic effect but worsening of CHF? [HeartWire > News; Dec 16, 2003 ]
    11. Another analysis shows increased risk of AMI with rofecoxib [HeartWire > News; Oct 29, 2003 ]
    12. Experts clash again over safety of COX-2 inhibitors [HeartWire > News; Oct 16, 2003 ]
    13. Concern over CV effects of COX-2 inhibitors, revisited [HeartWire > News; Nov 26, 2002 ]
    14. Another study singles out rofecoxib for cardiovascular side effects [HeartWire > News; Oct 4, 2002 ]
    Knowledge is power ... Stay informed!
    YOU can make a difference - all you have to do is try!

    Dx age 12 current age 46 and counting!
    lost: 5 family members to HCM (SCD, Stroke, CHF)
    Others diagnosed living with HCM (or gene +) include - daughter, niece, nephew, cousin, sister and many many friends!
    Therapy - ICD (implanted 97, 01, 04 and 11, medication
    Currently not obstructed
    Complications - unnecessary pacemaker and stroke (unrelated to each other)

  • #2
    Re: VIOXX WITHDRAWN from market

    I stopped taking Vioxx this morning.
    I have a problem with my hip, so I guess I will have to go see the doc and see what else is available.
    Celebrex didn't work as good for me.
    I have been taking Vioxx for just over a year and stangely I have had slightly elevated BP for the past year, now I see that is one of the effects of Vioxx.
    So hopefully going off Vioxx will decrease that.
    Every great thing that has ever happened since the beginning of time has started as a single thought in someones mind.
    So if you are capable of thought then you are capable of great things
    Good luck and stay well.
    Glen

    Comment


    • #3
      Re: VIOXX WITHDRAWN from market

      Hi Glen,
      How are you doing buddy? You say you have a bad hip? Well my friend I have degenerative arthritis in both shoulders, both hips, my tailbone, my left thumb (I’m a lefty) but most of all, in my spine – the bottom half in particular. I have bone spurs and degenerative ‘changes.’

      I went through cortisone shots, with decreasing effectiveness, years ago and a number of other supposedly helpful medications – including Vioxx. Currently I carry, and occasionally actually take a 5/500 mixture of hydrocodone and APAP. (That’s generic for Lortab.) (Hydrocodone is an extract of codine with less negative side effects.) My PCP is willing to send me to an orthopedic specialist, but I’m not there yet, and I have so many doctor’s now I don’t know if I could fit another one in.

      I’m not a great fan of narcotics, so I don’t take a steady dose of this medication, but when the pain starts to interfere too much I will pop a pill. It doesn’t make the pain go away, but it does take the edge off it so I can ignore it as I do normally.

      By the way, stay away from Motrin – it ain’t good for HCMers.
      Burt

      Comment


      • #4
        Re: VIOXX WITHDRAWN from market

        Burt - I think that Motrin is fine for HCMers. Dr. Siegel actually recommended that I take it to increase my blood pressure. It is a vasoconstrictor - the things that are bad for HCMers are vasodilators.

        As far as I know, aspirin, tylenol and motrin are all fine for HCM'ers.
        Daughter of Father with HCM
        Diagnosed with HCM 1999.
        Full term pregnancy - Son born 11/01
        ICD implanted 2/03; generator replaced 2/2005 and 2/2012
        Myectomy 8/11/06 - Joe Dearani - Mayo Clinic.

        Comment


        • #5
          Re: VIOXX WITHDRAWN from market

          Actually Motrin is an NSAID ( nonsteroidal anti- inflamatory drugs).
          It is not recommended for most HCM people although many doctors do prescribe it. Unfortunately for many HCMer's it interfers with their ability to get rid of fluid thereby worsening CHF symptoms. This is true for all NSAIDS.
          Dx @ 47 with HOCM & HF:11/00
          Guidant ICD:Mar.01, Recalled/replaced:6/05 w/ Medtronic device
          Lead failure,replaced 12/06.
          SF lead recall:07,extracted leads and new device 2012
          [email protected] Tufts, Boston:10/5/03; age 50. ( [email protected] 240 mmHg ++)
          Paroxysmal A-Fib: 06-07,2010 controlled w/sotalol dosing
          Genetic mutation 4/09, mother(d), brother, son, gene+
          Mother of 3, grandma of 3:Tim,27,Sarah,33w/6 y/o old Sophia, 5 y/o Jack, Laura 34, w/ 5 y/o old Benjamin

          Comment


          • #6
            Re: VIOXX WITHDRAWN from market

            Ah...I guess this is one of those where it depends on the patient. My doctor (who Burt shares at this point) is always trying to keep my volume UP and have me retain more fluids because my BP is very low. I do not have CHF issues though. I suppose if I did, it would be bad.
            Daughter of Father with HCM
            Diagnosed with HCM 1999.
            Full term pregnancy - Son born 11/01
            ICD implanted 2/03; generator replaced 2/2005 and 2/2012
            Myectomy 8/11/06 - Joe Dearani - Mayo Clinic.

            Comment


            • #7
              Re: VIOXX WITHDRAWN from market

              Hi Cynthia,
              I was told to stay away from all NSAIDs – and so were a number of other HCMers I’ve been talking too. I guess it’s the old story of different strokes for different folks.

              I would strongly suggest that anybody who wants to use it should check with their own cardiologist first. Might just as well be on the safe side.

              Aspirin and Tylenol are fine (except I take aspirin daily), but ibuprofen and motrin are not good for those of us who are hypertensive.
              Burt

              Comment


              • #8
                Re: VIOXX WITHDRAWN from market

                I was told not to take it also as i have CHF and that is a very bad no no for someone that does, I do take a asprin daily and tylenol for Athritis a couple times a day and tylenol pm at night for chest pains,

                So i get us that have CHF should avoid Motrin, Advil and so forths

                Shirley
                Diagnosed 2003
                Myectomy 2-23-2004
                Husband: Ken
                Son: John diagnosed 2004
                Daughter: Janet (free of HCM)

                Grandchildren: Drew 15,Aaron 13,Karen 9,Connor 9

                Comment


                • #9
                  Re: VIOXX WITHDRAWN from market

                  Hi Burt, doing pretty good.
                  I know what you mean about not taking the pain away, but it does take the edge off. Doc says I'm probably a few years away from a hip transplant.
                  I was also told not to take Motrin because I was already taking Vioxx and they are both NSAIDS and I shouldn't be over doing it because of HCM. I was told if I needed help to use Tylenol ot Tylenol with Codene.
                  I also take Glucosamine and it seems to help.
                  I am seeing him in a couple weeks and I'll talk to him then about a replacement.
                  Already tried Celebrex and it didn't work as good.
                  Every great thing that has ever happened since the beginning of time has started as a single thought in someones mind.
                  So if you are capable of thought then you are capable of great things
                  Good luck and stay well.
                  Glen

                  Comment


                  • #10
                    Re: VIOXX WITHDRAWN from market

                    Hi Glen,
                    I think what you meant to say was that in a few years you would be a candidate for a hip replacement – which is getting to be a rather common procedure, at least here is the states.

                    I’ve had a number of friends who have had it done (along with replacement knees.) As far as I’ve been able to tell the procedure will lay you up for a few weeks, decreasing in discomfort as time goes by until you forget you’ve had it done at all. Not that the pain comes back, but like it was before you had a hip problem.

                    In my father’s time many people thought you went to the hospital to die. First of all because it was relatively so expensive only the very sick went, and secondly there was considerably less that medicine could do to cure or control the problems they faced. Nowadays hospitals are more and more becoming repair shops for the body – replacing joints, bones and organs right and left.

                    When Social Security started in the States in the early thirties the average life expectancy was in the fifties, and most people were not expected to live long enough to collect on it, starting at age sixty-five. Today the average life expectancy is in the eighties, and almost everybody collects on it. I guess what I’m trying to say is that in about the last seventy years the average life expectancy has jumped up thirty years. Medicine must be doing something / ‘a lot of things,’ right. At that rate for every two years you still are expected to life, one year will be added to your average life expectancy. There will be masses of hundred year olds roaming the countryside. I can see it all now.
                    Burt

                    Comment


                    • #11
                      Re: VIOXX WITHDRAWN from market

                      I have two friends (actually more) but these two are husband and wife.
                      The husband had both knees replaced, the wife one knee and a knee cap on the other leg.
                      I don't know what they do, but they sure know how to go thru knees.
                      You should go to the airport with them and watch them go thru the metal detector.
                      Every great thing that has ever happened since the beginning of time has started as a single thought in someones mind.
                      So if you are capable of thought then you are capable of great things
                      Good luck and stay well.
                      Glen

                      Comment

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