Pradaxa has been linked to more than 500 deaths in the United States, yet it remains on the market as a “safe” drug. The FDA approved Pradaxa in October of 2010, as a new alternative to the existing anti-clotting drug warfarin; however, unlike warfarin (brand name Coumadin), there is no antidote to reverse Pradaxa’s blood-thinning effects. Many doctors and members of the medical community, as well as the families of victims who bled to death, wonder why the FDA allowed a dangerous drug to enter the market, particularly without having an option to reverse its side effects.
Both Pradaxa and warfarin are anticoagulant drugs are used to prevent or treat blood clots and reduce the risk of stroke, particularly in patients with atrial fibrillation. Carefully administered doses of Vitamin K can be used as an antidote to warfarin in cases of over-anticoagulation. Pradaxa manufacturer, Boehringer Ingelheim, claimed to be working on developing an antidote but said that even without one, patients in their clinical trial died at roughly the same rate as those taking warfarin. Rather than admit the drug is dangerous, doctors are being blamed for not sufficiently vetting patients who are being prescribed Pradaxa.
Pradaxa was marketed as safer alternative to warfarin based on the claims that it does not require extensive blood tests to optimize dosing as warfarin does, and the fact that warfarin interacts with numerous other drugs. According to Levin Papantonio shareholder and Pradaxa attorney, Ned McWilliams, “Pradaxa is being marketed as the more convenient, more effective and safer alternative to warfarin – but in reality the opposite is true. Adding insult to injury, BIPI is charging Americans and our health care system more than 10 times the costs of warfarin.”
Boehringer Ingelheim is an international pharmaceutical company, based in Ingelheim, Germany, that manufactures OTC and prescription drugs (including Pradaxa, Zantac, and Dulcolax), as well as vaccines and drugs for farm animals and pets. They are a corporate funder of the American Legislative Exchange Council (ALEC), a corporate bill mill that is worse than a lobby or front group. Over 98 percent of its revenue comes primarily from corporations or corporate foundations, which allows corporate interests to push bills that undermine environmental efforts and healthcare reform efforts, support school privatization, disenfranchise voters through strict election laws, fund climate change science denial, and much more.
Just last year, Boehringer Ingelheim was forced to pay $95 million to federal and state governments for illegally promoting some of its drugs for unapproved uses and dosages, including the drugs Aggrenox, Atrovent, Combivent, and Micardis. At the same time, the company settled allegations that they had paid kickbacks to doctors and healthcare providers in order to promote and sell their products. The US Department of Justice also cited the company for intentionally making “unsubstantiated claims about the efficacy” of their drug Aggrenox, which is intended to prevent subsequent strokes, or strokes due to blood clots.
Alisha Mims is a Content Management Specialist for Levin, Papantonio law firm, a writer, and contributor to Ring of Fire.