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Pradaxa v. Warfarin

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Washington, DCIf you need an anticoagulant and are given a choice of Pradaxa or warfarin, chances are you would not opt for Pradaxa, unless you wanted to bleed to death.

Boehringer Ingelheim, the Pradaxa manufacturer, announced in May 2014 that it will pay $650 million to settle all 4,000 state and federal Pradaxa (generic dabigatran) lawsuits, which meant that each claimant would receive $162,500. All the lawsuits claimed that Pradaxa can cause uncontrolled bleeding and often result in death. More than 540 patients in 2011 alone bled to death after using the blood thinner and thousands of patients suffered serious complications. Armed with these figures, the FDA safety alert in November 2012 evaluated information about the risk of serious bleeding associated with use of the anticoagulants (blood thinners) dabigatran (Pradaxa) and warfarin (Coumadin, Jantoven and generics). The agency concluded that “bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin.”

But independent doctors and researchers beg to differ. Consider the following:

Since 2010, these new anticoagulant drugs, known as novel oral anticoagulants (NOACs) - Pradaxa, Xarelto and Eliquis - have been linked to at least 8,000 deaths, whereas warfarin (Coumadin) has been associated with 700 deaths, according to an investigation by Milwaukee Journal Sentinel/MedPage Today.

The investigation found that, since 2010, more than 58,000 people have reported a serious side effect, such as a major bleeding episode, after using one of the anticoagulants designed to replace warfarin.

The three NOACs accounted for less than 10 percent of all anticoagulant prescriptions yet they are linked to more than 90 percent of deaths reported to the FDA - and recorded in the agency's adverse events reporting system - since 2010.

Warfarin is a vitamin K antagonist that can be turned off in a bleeding emergency or prior to surgery by administering vitamin K. All of the NOACs were approved without an antidote that can stop the blood loss, creating the potential for dangerous uncontrolled bleeding.

Marketing campaigns promote the new drugs as more convenient than warfarin: they don’t require INR (International Normalised Ratio) testing that checks how long it takes blood to clot, nor do they require dietary restrictions like warfarin. Incredibly, the NOAC drugmakers spent at least $60 million marketing their new products to the medical community, both in Europe and the US.

The MedPage Today investigation found that a British doctor, Gregory Lip, is the forefront in promoting Pradaxa and the other new anticoagulants. He has extensive financial ties to the NOACs drugmakers.

Lip devised a scale to determine who should receive anticoagulant drugs. According to JAMA Internal Medicine (May 2015), the number of patients in the US requiring an anticoagulant immediately increased from an estimated 3.7 million to 4.7 million. Lip’s scale has been adopted by four leading medical societies in the US and Europe. Again, according to the investigation, those societies have received at least $40 million in the last three years from the pharmaceutical companies that make or market the NOACs, including Pradaxa.

Independent doctors, i.e., those not paid by the new NOAC makers, believe that for some patients with atrial fibrillation, the risk for life-threatening bleeding associated with Pradaxa rather than warfarin outweighs any benefit.

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