New generation anti-coagulant Pradaxa comes with a long list of safety warnings, including bleeding, which can lead to death. All anti-coagulant drugs carry this risk, but unlike other anti-coagulant medications that have been on the market for a long time, Pradaxa has no known antidote.
Why Patients are Prescribed Pradaxa
Older anti-coagulants, like Warfarin, can require several blood tests to adjust the dosage correctly. Therefore, patients taking these drugs have to be monitored. But the appeal with Pradaxa is that doctors can prescribe a fixed dose without having to monitor the patient as frequently as with Warfarin. Pradaxa even highlights this “benefit” on its website, saying “unlike warfarin, there is no need for regular blood tests to see if your blood-thinning level is in the right range.”
Another benefit that Pradaxa’s manufacturer Boehringer Ingelheim has touted is the fact that Pradaxa requires no changes to the patient’s diet. In contrast, patients who take Warfarin have to avoid foods like green vegetables and some vegetable oils that have a high concentration of vitamin K because of the interactions it can have with the medicine.
Bleeding Caused by Pradaxa is Irreversible
Boehringer Ingelheim pushed Pradaxa onto the market using a strong sales force that convinced doctors to prescribe Pradaxa without giving them vital information about how to stop life-threatening and sometimes fatal bleeding in their patients.
Patients on all blood thinners can and do bleed, but well-studied and effective methods for reversing the bleeding are commonly known by doctors and other health care providers. With Pradaxa, there is no peer-reviewed research and no consensus in the medical community about how to stop the bleeding when it does occur.
A recent study published in Circulation studied the effects on Pradaxa of prothrombin complex concentrate (PCC), which is essentially a well-known antidote to other anti-coagulants in patients who experience major bleeding events. The results of the study showed that despite all of Pradaxa’s benefits, a major disadvantage of Pradaxa is that there is no known antidote for cases of serious bleeding or emergency corrections of blood clotting. This was the first study conducted on humans to attempt to find an antidote for Pradaxa.
Doctors Call on Pradaxa’s Manufacturer to Find an Antidote
Worldwide, as many as 260 patients have died after experiencing severe bleeding while taking Pradaxa. Doctors can do nothing but stand by, idly watching their patients bleed to death after taking Pradaxa, because they can do nothing to reverse the bleeding. Had their patients been on other anti-coagulants, the bleeding could have easily been stopped and the patients’ lives saved.
As of yet, Boehringer Ingelheim has not published data in peer-reviewed journals on how to reverse the serious bleeding events associated with Pradaxa. And until either more studies are conducted on Pradaxa, or Boehringer Ingelheim finds an antidote, patients will continue to suffer and potentially die from serious bleeding events while taking Pradaxa.
If you suffered a serious bleeding event while taking Pradaxa, or if a loved one suffered a fatal bleeding event while on Pradaxa, call experienced Dallas drug injury lawyers at Van Wey, Metzler & Williams, PLLC today at (214) 329-1350 or (800) 489-5082 to learn more about your legal rights.
By: Kay Van Wey | January 10th, 2016