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Boehringer Ingelheim Files for FDA Approval for Pradaxa Antidote

Pradaxa is an oral anticoagulant similar to Xarelto and Eliquis, which has been prescribed to patients with a serious medical condition known as atrial fibrillation (Afib) as an alternative to Warfarin and other traditional blood thinning agents. Afib patients are higher risk for serious clotting disorders that can lead to stroke, heart disease, pulmonary embolism (PE), and other serious medical conditions.

syringes-and-vial-1028452-m.jpgTraditionally, doctors prescribed these patients Warfarin or even aspirin to thin the blood and help prevent issues. One major concern for Warfarin patients is that it requires constant monitoring and dosage changes to make sure a patient is taking the correct amount. There are also foods that can affect Warfarin absorption rates. Patients on Warfarin must have frequent blood tests, follow-up visits, and watch their diets closely to prevent problems, including serious bleeding disorders.

Drug companies marketed Pradaxa and its fellow class members as a safe and effective alternative that did not require constant monitoring. The problem, as we now know, is taking Pradaxa can lead to serious interal bleeding disorders, including intracranial bleeding. If a patient presents at the emergency room with an internal bleeding disorder due to a new oral anticoagulant (NAOC) such as Pradaxa, there is no FDA approved treatment, and many patients have died as a result.

While the drug companies could take these dangerous products off the market, they are not willing to do so, possibly because of the huge profits they are seeing from sales of these drugs.

Instead, as our Boston Pradaxa injury lawyers understand, they are banking on a new Pradaxa antidote developed by Boehringer Ingelheim known as idarucizumab. It should be noted, this new drug does not have a catchy marketing name because it is not being sold directly to patients, and drug companies probably don’t want the public to think they may need an antidote for a medicine that is supposed to be safe and effective.

According to a recent news report from PharmaTimes, Boehringer Ingelheim has submitted idarucizumab for United States Food and Drug Administration (FDA) approval and also to FDA’s European counterpart. The company may be able to get fast tracked approval for their new drug, as there is no currently approved alternative on the market and patients have died from these new blood thinning medications.

In some cases, drug companies are able to give experimental drugs to human patients without extensive trials, because the patient is likely to die without the medication. This is known as the “compassionate use” exception to a requirement for FDA approval before doctors can administer a drug. While there may clearly be a benefit to a patient dying of a Pradaxa-related internal bleeding disorder, it should be noted drug companies have expressed a strong desire to sell these known dangerous drugs.

With many cases against the makers of Pradaxa already working their way through the court system, if you or a loved one has been injured from taking the drug, it is important to contact an experienced Pradaxa injury attorney as soon as possible, as your rights in future case may be affected by cases already filed.


If you are the victim of a defective medical device in Boston, call the Law Offices of Jeffrey S. Glassman for a free and confidential appointment — 1-888-367-2900.

Additional Resources:

BI files Pradaxa antidote in US, EU and Canada , Mar. 3, 2015, PharmaTImes

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