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Vioxx Fears Force Product Withdrawal

Futurist Keynote Speaker: Posts, Slides, Videos - Future Health Care and Pharma Keynote Speaker

Vioxx is withdrawn from market on 1st October 2004, after concerns that long term use may lead to increased risk of heart attacks and stroke. However, those taking Vioxx are recommended to seek medical advice before ceasing the drug since the alternatives may cause greater health risks from ulcers. Celebrex is not affected by the health scare and can be expected to benefit in sales. Watch for more research to see if the problem with Vioxx is common to Celebrex too. If both are withdrawn it will be a great blow to people with chronic pain will will then find themselves at far higher risk of bleeding ulcers.
 Vioxx for arthritis pain has become a top competitor for Celebrex (also for arthritis pain) both outselling for a time the record-breaking sex performance drug Viagra. 

Vioxx is made by Merck with $208m sales in the first 20 weeks from launch. Merck also make the very successful drug Fosamax for osteoporosis which saw 27% sales growth last year (total $350m). 
More than 2 million Vioxx scripts in US - 60,000 every week. 19% of all scripts for arthritis pain are now Vioxx.
 Vioxx has NOT had the media coverage of Celebrex or Viagra - with only 1,000 mentions in 100,000 publications we have reviewed up to early November 1999.  That may sound a lot but Viagra scored thousands in a few months after launch.  Likewise there are only a few world-class Vioxx web pages.
 Vioxx (rofecoxib) is a direct competitor for Celebrex approved May 20th 1999. 
 Monsanto's attempt to prove that Vioxx infringed their patent for Celebrex has failed.
 Vioxx is now being introduced in 22 other countries.
 Vioxx is also being marketed to US dentists
 Vioxx has a similar method of action to Celebrex and is being marketed as a lower risk alternative to NSAIDs or non-steroidal anti-inflammatory drugs which hospitalize 117,000 and kill 16,000 every year in the US alone.
 Ordinary NSAIDs are great at punching holes through gut with terrible results.  Bleeding can be sudden and severe.  Signs may be confusing to the inexperienced with abdominal pain and sometimes vomit of what looks like coffee grounds.  Without prompt expert medical attention the result can be fatal in some cases.  The "coffee grounds" are partly digested blood from a big bleed.  Blood is irritating to the gut.  If the person does not vomit they may pass very dark stools a few hours or a day or two later.
 Bleeding ulcers caused by NSAIDs can be a major medical emergency with many pints of blood needed, plus urgent surgery to try and stop the hemorrhage - and all caused by doctors treating pain with NSAIDs.  That's why there is the intense interest in Vioxx and Celebrex.
 And we're not just talking about pain relief in arthritis.  Millions of people every year treat themselves with NSAIDS such as Brufen without ever going near a physician - for headache, migraines, muscular aches and pains, sprains, back problems and other discomfort. 
 The risk is actually quite low for getting a bleeding NSAID ulcer unless the dose is high for a prolonged period - see below - but because so many millions of people have been taking them every day, 16,000 have been dying every year in the US alone.
 Vioxx inhibits the Cox-2 enzyme which is linked to inflammation, without affecting gut function.
 Vioxx side-effects include nausea, upper respiratory infection and dry mouth.
 Vioxx can produce a potentially dangerous drug interactions with methotrexate, warfarin and rifampicin.
 50% of Vioxx scripts are "new" - for newly diagnosed people with arthritis rather than people converting from over the counter NSAID scripts
 New study shows that patients treated with Vioxx are less likely to develop ulcers compared to those taking Brufen (ibuprofen).  However ulcers can still occur.  Prof Loren Laine, University of Southern California, took 742 patients with osteoarthritis and divided them into three groups: 25mg or 50mg Vioxx (normal dose is 12.5mg), 800mg of Brufen or a placebo (tablet that looks identical but has no active ingredients).  Neither doctors nor patients knew what they were getting.  Ulcers were detected by using a small camera (endoscope).
 Ulcer rates after 12 weeks therapy (hole wider than 3mm)

        Vioxx 25mg = 4%    Vioxx 50mg = 7%

        Brufen = 28%    Placebo = 10%  Conclusion:  Vioxx is much safer with ulceration rate similar to what you would expect in an untreated population.
 The results were even more striking after 24 weeks: Brufen ulcer rates rising to 46% compared to 10% and 15% for those taking 25mg or 50mg Vioxx.  With results as spectacular as this some would argue that it becomes unethical to continue comparison studies, because of the risk of harm to those on placebo who need relief and the needless risk to health of those denied Vioxx.
 Vioxx seems to work as well as naproxen for menstrual pain, according to a new study comparing 550mg naproxen to 50mg Vioxx every 12 hours.  The double-blind controlled trial included 127 women for over four months.
 Health service chiefs and insurance companies are worried about budgets being wiped - Vioxx and Celebrex are far more expensive - but perhaps not when you add in treatment of side effects and of course lives saved
 These pages are updated regularly from our searches of 100,000 newspaper / magazine daily / weekly sources from across the world.
 Bookmark this page for fast updates on global Vioxx news.



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