FDA-Approved Drug Linked to 542 Deaths and 2,367 Hemorrhages, but FDA Refuses to Pull It

April 2, 2013
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Pradaxa-1It couldn’t be because it brings in over $1 billion in sales each year, could it?

Pradaxa (dabigatran) is an anti-clotting drug used to treat a type of irregular heartbeat called nonvalvular atrial fibrillation (AF) and to prevent strokes. It’s used as an alternative to warfarin, an older drug, and needs less monitoring (warfarin requires regular doctor’s visits, blood tests, and dietary restrictions). In clinical trials, Pradaxa outperformed warfarin in reducing the risk of stroke, and it initially appeared to be safer, causing less hemorrhaging. But that turned out not to be the case. In 2011, Pradaxa caused 542 people to bleed to death.

FDA states that Pradaxa’s bleeding rates “do not appear to be higher” than warfarin, even though elsewhere on FDA’s website, we see that the risk of bleeding from Pradaxa is six times greater than with warfarin—usually in a pericardial location. Warfarin is also dangerous, and is one of the leading causes of emergency room fatalities. In 2011, warfarin was the subject of 1,106 serious adverse events, including 72 deaths.

Warfarin’s greatest flaw is also its saving grace: its blood-thinning effects can be counteracted with vitamin K, found in the K1 form in abundance in green leafy foods. This means that warfarin stops its beneficial work if you eat too many leafy greens—but if you start hemorrhaging, vitamin K is a swift antidote. No such antidote exists for Pradaxa: if you start bleeding, you will bleed to death.

The drug has spurred more reports of injury or death than any of the more than 800 drugs monitored by the Institute for Safe Medication Practices. To date, FDA has refused to recall the drug or address the “no antidote” issue.

This exemplifies one of our great concerns about the drug approval process. How can the FDA approve a drug that causes uncontrollable bleeding with no antidote? It also calls into question the quality of the clinical studies and random-controlled trials. How can the initial trials have indicated that Pradaxa causes less hemorrhaging when it actually causes six times more? Clearly, trial results can be skewed to benefit drug manufacturers.

Worse, since warfarin works, there was no urgent requirement for Pradaxa approval—or its continued presence on the market, now that it has been shown to be dangerous. The only thing that justifies its sale is the fact that it’s a big money-maker. It brings in over $1 billion a year—about $3,000 per patient, costing sixty times more than warfarin ($48 per patient). That’s a significant income for a drug that’s been on the market for only two years. By August 2012, more than 3.7 million US patients had filled Pradaxa prescriptions. The anticoagulant therapy market is estimated to bring in $10 billion a year in the United States alone.

And it’s an expanding market. In Europe, for example, Pradaxa is used to treat venous thromboembolism (VTE) after knee or hip replacement surgery. Boehringer Ingelheim, the manufacturer, is currently having clinical trials for this indication, so it’s possible the drug will be approved for even more uses in the US.

One of the problems is that the drug is usually prescribed by cardiologists, while the ones who see the consequences of bleeding are ER doctors. Conventional medicine is by nature a fragmented system.

Though the FDA is refusing to take action, more than 100 lawsuits have already been filed and more than 1,000 are expected, even after screening out obviously fraudulent and questionable cases. Plaintiffs are planning a mass joint claim against Pradaxa’s manufacturer. The plan is to use multidistrict litigation instead of a class-action suit to speed up the process.

This is not the first time FDA has approved a dangerous drug for atrial fibrillation. You may recall our report about Multaq, a drug that treated cardiac arrhythmias. Its clinical trial was stopped because more patients who were getting the drug were dying than those who received a placebo—though the study results weren’t published until five years later. Even so, the drug was approved by the FDA in 2009 as a treatment for AF in certain patients.

Of course there is an abundance of natural treatments for AF and to prevent stroke. Dr. Robert J. Rowen points out that not only do drug-thinning drugs increase risk of hemorrhaging, they also stop vitamin K production, and vitamin K is responsible for helping blood to clot and, in the K2 form, is also important for getting calcium into bones: “The truth is most people with atrial fibrillation never develop clots. They have a clotting system that’s operating normally. Those who do develop clots have other non-heart risks for thick blood. These include deficiencies in nutrients that have been proven to help regulate the body’s clotting mechanisms.” He recommends omega-3 fatty acids, vitamin E, bioflavonoids (such as ginkgo), garlic, and nattokinase, a nutrient made from fermented soy, which optimizes your blood’s clotting system. In 2010 we noted that nattokinase also may remove amyloid plaque, so it may be a promising treatment for Alzheimer’s, in addition to other foods and supplements we’ve told you about.

Other good natural methods of stroke prevention include obesity reduction, taking vitamin D to avoid sulfate deficiency (which could be an underlying cause of arterial plaque build up), and managing blood sugar levels.

Dr. Rowen also recommends getting to the root cause of the AF rather than just treating its symptoms. He notes that hypothyroidism could be one root cause predisposing people to AF.

32 Responses to “FDA-Approved Drug Linked to 542 Deaths and 2,367 Hemorrhages, but FDA Refuses to Pull It”

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       0 likes

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       0 likes

  3. abinico warez says:

    A few dead patients (or even a whole bunch) is the price of modern medicine. The fact that modern medical system kills over 200,000 yearly is purely coincidental.

       0 likes

  4. Bonny says:

    Last night I was reading about Arginine, which is Nitric Oxide and it can be used as a blood thinner. Check out this video: War on heart disease
    http://www.mycardioforlife.com/index.php/videos#&panel1-3
    My husband has been on Pradaxa and I have been trying to find an alternative and I think Arginine is the answer I have been looking for!

       0 likes

    • ThomasT says:

      Natural vitamin E is also a blood thinner, (d-tocopherols).

      BUT if arteries are clean, you don’t ned to worry. The well documented causes of arterial calcification are:

      1. High blood homocysteine, that lowered with vitamins B6, B12, and folates. Vit. (B6 is synthesised in the gut by the friendly bacteria, in the presence of cream, butter, & full fat milk products. Malhotra SL Dr. et al. 1974-present. Lancet). Idiotic advice is to avoid cream, butter etc. Supplementing is also advised against.

      2. Lipo-protein alpha, LDL, is lowered with anti-oxidants, such as vitamins, selenium and l-cysteine amino acid. ( 3 egg yolks daily normalise the LDL marker,the indicator of artery inflammation. This inflammation leads to calcification. (Useless, toxic Statins lacking anti-oxidants do not even slow calcification, but merely alter the LDL marker by interfering with liver function). Egg yolks also contain Vitamin K2 essential to aid blood clotting and calcium deposition, and also contain the brain and nervous system foods, so valuable for the very young and elderly, the phosphotidyls, serine and choline! Idiotic advice is to consume only 2 yolks a week.

      3. Causative high triglycerides, are blood fats elevated by too many carbs., especially sugars, and, alcohol. Idiotic ‘healthy eating’ food group advice is to stuff yourself with carbs all day, ie grains 6X daily, unlimited fruit, and no restrictions on sugar, HFCS etc.

      If the arteries are already narrowed, then EDTA cleans them out. Orally it takes 6 months and costs little. IV drip is quicker and expensive. Oral EDTA is banned by UK Govt.

      For irregulat heartbeat you MUST ZERO ALLL MSG. I tried to kick my erratic heartbeat brought on by an MSG overdose in a Chinese rest. I must have sensitized to MSG living in Hong Kong for 30 years and just tipped across. For a year I tried every natural method known to man, but failed, till I realised that ALL bacon has MSG, It then 100% cleared up in weeks. I now avoid ANY MSG and it;s fine.

         0 likes

  5. Nancy says:

    My husband was scheduled for surgery to have a shunt put in his brain to help the fluid of the brain NPH drain. After realizing he is on Pradaxa the surgeon decided not to perform the procedure. I now wonder how long he should be off the Pradaxa before he can have the surgery?? Does anyone know this answer. We do not have a good repore with our Primary and seem never to get any correct answers, he thinks this drug is wonderful. I should tell you my husband has been on Pradaxa for 3 years, he use to be on coumodin but was taken off because of the INR reading and they could never get the right dosage. I am truly concerned.

       1 likes

    • Elisabeth Gibson says:

      Speak to your pharmacist, he/she is likely a better resource of information regarding your husband’s medications. Also, FDA.gov. The drug inserts, study results, etc…are online for viewing there. Best wishes.

         0 likes

      • Mark says:

        There is no “my” pharm scam artist. Virtually nothing those crooks peddle can be considered anything but poison.

           0 likes

    • Rose says:

      At least stop taking pradaxa 7 days before surgery. Again check with the surgeon. My son is taking it and I have read it somewhere.

         0 likes

  6. Ronice Jones says:

    Simple greed and population control tactics

       1 likes

  7. Ronice says:

    Simple greed and population control.

       1 likes

  8. Sandi says:

    Thank you so much for all that you do regarding alerts. This info allows many of us to see more than one side so that if we find ourselves in a position to even consider a treatment, we can look at it from all angles before making our “more informed” decision. Keep up the good work!

       4 likes

  9. Chris Hall says:

    Yes, first hand experience that Pradaxa will not allow the use of Vit K in the event of stroke. When my Mom had a stroke, the doctor on call in the E.R. knew of no way to mitigate the stroke my mother had while on Pradaxa. No one in my family was aware of the risk the Pradaxa represented. We were and still are devastated. I still see Pradaxa advertised without mention of this hazard.

       1 likes

  10. John says:

    Good info, background, and discussion of natural alternatives. But the drug’s brand name is Pradaxa (not Pradexa).

       0 likes

  11. public_servant_watch says:

    I am with you 100% and this war against the people where Big Pharma is one of the many weapons MUST be fought by an engaged FDA. Congress needs to step up and straighten out the largest lobbyist in DC which is “Big Pharma” and the FDA needs monitoring through newly established law. Congress has over the years continually promoted a situation that they created where a true conflict of interest exist; the lobbying needs to immediately cease. A buck in someone’s pocket does not trump another’s quality of life and certainly does not trump life itself.

    These pharmaceutical companies MUST face consequence from the courts beyond monetary fines; they have plenty of money. If these pharmaceutical companies are settling with states for various reasons yet still profiting because doctors in the states are still prescribing the drug(s) at issue in a previous litigation the appearance of a creative kick-back scheme evolves. The aforementioned is particularly true when tax dollars are paying for the drugs and especially true when these drugs are prescribed in high volume at state hospitals. Sorry but you or I would be in prison if indicted and found guilty on racketeering charges AND no one in this situation is exempt from law!!!

       5 likes

  12. Denise Epstein says:

    Great Article but what do we do with this information? We are being drugged, poisoned and killed by Big Pharma and no one has our backs as money is valued over life.

       3 likes

  13. JK says:

    The FDA needs to stop banning or trying to ban harmless substances while allowing toxic drugs such as Pradexa to remain on the market. We need more honesty and less catering to the big pharmacies.

       3 likes

  14. brian says:

    The FDA wastes their resources montoring the supplement industry while the pharmaceutical industry is killing people every minute of the day….

       6 likes

    • Dee Cota says:

      Brian, you said a mouthful, and you are 100% right. I have been a member of the National Health Federation for almost 40 years and they have been battling the FDA on every issue concerning our right to have the freedom to buy vitamins, dietary supplements, herbs and of course organic food. We fought them over GMO’s, food additives, chemicals and just about everything else, to no avail. The FDA is an agency of the government, and as you may no, you can’t fight city hall, even if you are in the right. I don’t know if I can post the National Health Federation’s website here, but if anyone wants some real good facts about the FDA and how they operate, just Google the National Health Federation, they are located in Monrovia, CA. Hope you take the time to check them out.

         1 likes

  15. Joyce says:

    Personally I prefer Vitamin E to prevent clots instead of rat poison or pradaxa or other synthetic
    drug.

    Magnesium also goes a long way to help keep the heart in rhythm.

    People do not die from lack of any drug, but they do die from vitamin/mineral deficiencies.

       7 likes

  16. Rosemary Graham-Gardner says:

    The FDA should be retired as an agency because it has a foot in the two camps. They are a corrupt agency and should be replaced by a transparent agency with constant oversight..
    They are on the Tax payers payroll and are not doing their job to serve the Public.So the Agency should be shut down and replaced by an Agency that serves the Public as it is supposed to to as Public Servants!

       7 likes

  17. Mary Thoma says:

    More deaths hsve been caused by drugs than by vitamins and supplrments.

       6 likes

  18. Lloyd Downs says:

    I have used Warfarin safely for many years. No new drug is needed.
    Lloyd Downs

       0 likes

  19. Joyce says:

    FDA needs to take it off the market-I was almost put on that drug-my pharmacist warned me of the no reversal facts on Pradoxa–and the price I didn’t need to pay for a drug that was very dangerous that has been almost 3 years ago. Prescription drugs are the #1 killer above disease..

       3 likes

  20. Viola Perry says:

    Same goes for Lipitor jn my opinion. Half of the people dying of a heart attack have normal cholesterol level. But Lipitor is the cash cow for Big Pharma.

       4 likes

  21. Jan Lindner says:

    This stuff sounds much too dangerous for anyone to use. And treating symptoms with a deadly drug seems rather stupid. even if it is highly profitable. When is the FDA going to start putting human safety before corporate profit?

       2 likes

  22. Bruce Eyster says:

    The Food and Drug Administration is the oldest comprehensive consumer protection agency in the U. S. federal government. Its origins can be traced back to the appointment of Lewis Caleb Beck in the Patent Office around 1848 to carry out chemical analyses of agricultural products, a function that the newly created Department of Agriculture inherited in 1862. Although it was not known by its present name until 1930, FDA’s modern regulatory functions began with the passage of the 1906 Pure Food and Drugs Act , apparently due to a concern with hygiene . Much has changed since then and this branch, appointed to public well being, seems more focused on promoting money making and relatively experimental products . Who can forget the PROZAC craze , when every doctor was passing out prescriptions and ’samples’ from their desk drawer , like candy, as a cure all !? This agency is also responsible for prohibiting herbal and natural healing remedies . Isn’t it time this agency be brought into question, perhaps revised and updated according to the will, needs and advocacy of ‘we the people ” who are directly affected and foot the bill for their positions ? As opposed to the kick backs from the large pharmacol agencies .

       6 likes

  23. HSJenkins says:

    Ah, but there is clearly another rationale for the FDA to sustain approval for the drug. It’s in the interests of the medico-industrial complex to use unsuspecting patient populations as guinea pigs. That’s sooo much cheaper than having to foot the bill for formal studies. The situation is no different than with any fascist-corporatist enterprise: socialize the costs, privatize the profits. Welcome to 21st-century Amerika.

       5 likes

  24. Monika Nelson says:

    It seem that you consistently misspelled the name of the drug you are writing about. The label on the package clearly says Pradaxa, not Pradexa.

       0 likes

  25. How many more people will have to die before corporations put lives before profit? Must they always be forced to do the right thing?

       1 likes

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