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FDA Approves Antidote for Pradaxa

Pradaxa, like Xarelto and Eliquis have taken the blood thinner/anticoagulant market by storm in recent years as an alternative to the tried and true blood thinner Warfarin (Coumadin). These drugs were designed to treat patients with an irregular heartbeat condition known as atrial fibrillation (Afib).

untitled-1238929-mAfib patients are at a high risk of developing large blood clots, which can form within the veins deep within the legs. This is a serious and potentially deadly medical condition known as deep vein thrombosis (DVT). The clots can break free from the veins in which they formed and travel through the circulatory system to the lungs where they can cause a hole known as a pulmonary embolism (PE). They clots can also block blood flow to the brain resulting in a stroke.

To prevent PEs and stroke, doctor will prescribe a medication to prevent the blood clots from forming. For years this mean taking Warfarin (Coumadin). This medication is a blood thinner and works quite well, but the dose must be monitored closely to prevent internal bleeding. This is different than the clotting disorder the drug was meant to prevent. There are ways to reduce the risk of the internal bleeding disorder including having frequent blood tests to make sure the absorption rate for the drug is correct, and also the patient can watch his or her died because certain foods can affect the rate at which the blood thinner is metabolized. If a patient develops the serious internal bleeding condition, there is an FDA approved reversal agent (antidote) doctors can use to save the patient.

This was the market standard for many years before a new class of drugs known as New Oral Anticoagulants (NAOCs) entered the market. The drugs including Pradaxa, Eliquis, and Xarelto, are not blood thinners but anticoagulants, which work in a different manner. One of the benefits to this to using NOACs is that they do not need constant monitoring, as the dose is constant among most patients. The problems is that patients have developed a serious internal bleeding disorder from these drugs and there was no way for doctors to reverse the potentially deadly effects. In other words, there was not reversal agent and people were dying.

According to a recent news article from Medscape Multispecialty, the FDA has just approved a reversal agent for the potentially deadly effects of Pradaxa, and this new anticoagulant is known as Praxbind. Praxbind is made by Boehringer Ingelheim, which is the same company that makes Pradaxa. In other words, this company has no interest in pulling a drug with known deadly side effects from the market, because that would interfere with the record profits the drug is making the company.   Instead, the company created an antidote to its own drug. The company likes to use the term reversal agent instead of antidote, even though they mean the same thing. The likely reason they want to avoid having Praxbind referred to as an antidote is because that would make people Pradaxa is poison, which for many victims, it is as Boston Pradaxa injury attorneys are seeing in many cases.

If you are a victim Pradaxa and live in Massachusetts, call the Law Offices of Jeffrey S. Glassman for a free and confidential appointment — 1-888-367-2900.

Additional Resources:

FDA Approves Praxbind to Reverse Anticoagulant Pradaxa, October 17, 2015, Medscape Multispecialty

More Blog Entries:

Risk for Internal Bleeding after Taking Pradaxa, August 22, 2014, Boston Dangerous Drugs Injury Lawyer Blog