Pradaxa® Timeline Shows Five-Year Gap Between Approval and Development of Bleeding Antidote

German pharmaceutical company Boehringer Ingelheim developed its next-generation anticoagulant Pradaxa (dabigatran etexilate mesylate) in the mid-2000s to serve as an alternative to older blood-thinning drugs like warfarin. Offering one-size-fits-most dosage, and without the dietary restrictions and regular blood test monitoring associated with warfarin, Pradaxa quickly became wildly popular among atrial fibrillation patients at risk for blood clots and strokes, as well as their doctors.

red_blood_cellsPradaxa is the most popular direct thrombin inhibitor on the market today. Millions of patients in the United States take it as part of a daily prescription regimen, most having no idea that the drug's been linked to a number of concerning side effects and complications, including life-threatening or fatal uncontrollable bleeding events.

 

While almost all blood-thinners have the potential to cause unwanted internal bleeding, there's something particularly insidious about the bleeding dangers posed by Pradaxa. As a direct thrombin inhibitor, when Pradaxa causes serious or life-threatening bleeding, it can't be counteracted by administering a quick dose of vitamin K. Patients on warfarin usually stabilize with the introduction of vitamin K.

In fact, for years, Pradaxa couldn't be safely counteracted. When patients experienced life-threatening internal bleeding, the best doctors could do was subject them to dialysis with the hopes that it would clean the drug from their blood—which it did, slowly and not very reliably. As a result, what should have been a quick fix of a routine problem turned deadly for some Pradaxa patients.

If you were recently prescribed Pradaxa or experienced a serious bleeding event while taking the drug, here's what you need to know.

Pradaxa Approval and Uncontrollable Bleeding

A look at Pradaxa's development and approval history provides some interesting information. Among the most notable tidbits: a five-year gap between its approval and the approval of its antidote, Praxbind®. Consider the following timeline:

  • 2008: Pradaxa is approved for use in Europe by the European Medicines Agency for the prevention of blood clots in patients who had total knee or hip replacement surgery.
  • 2009: Boehringer Ingelheim researchers submit Pradaxa trial data to The New England Journal of Medicine.
  • 2010: Boehringer Ingelheim applies for and receives approval from the U.S. Food and Drug Administration (FDA) for Pradaxa. The FDA approves the drug for the prevention of stroke in patients with atrial fibrillation.
  • 2011: Japanese pharmaceutical regulators ask Boehringer Ingelheim to notify doctors of potentially deadly Pradaxa bleeding risks, after receiving reports of adverse bleeding events.
  • 2011: The medical journal Therapeutics Initiative questions the validity of Pradaxa trial data after discovering what it described as "flaws" in the methodology.
  • 2011: Boehringer Ingelheim reports nearly 300 fatal Pradaxa bleeding episodes.
  • 2011: Health agencies around the world recommend that doctors adjust the dosage of Pradaxa patients with a history of kidney problems or renal impairment. The European Medicines Agency updates Pradaxa's safety warnings to reflect kidney function concerns.
  • 2011: The FDA announces that it will conduct a safety review of Pradaxa.
  • 2012: Doctors and pharmaceutical regulators from several countries urge for stronger safety measures for Pradaxa, after receiving hundreds of reports of life-threatening and fatal bleeding events.
  • 2012: Patients who experienced life-threatening bleeding events, and the families of some patients who died, file lawsuits against Boehringer Ingelheim.
  • 2012: Multiple medical journals publish studies on the prevalence of life-threatening bleeding events among patients taking Pradaxa.
  • 2012: The U.S. Judicial Panel on Multidistrict Litigation consolidates Pradaxa lawsuits into an MDL to be litigated in the Southern District of Illinois with U.S. District Court Judge David R. Herndon presiding.
  • 2015: The FDA approves Praxbind, Boehringer Ingelheim's Pradaxa reversal agent.

Do You Have Questions About a Potential Pradaxa Bleeding Lawsuit?

Thousands of patients have filed lawsuits against Pradaxa's manufacturer, claiming the company continued to market and sell a drug it knew was dangerous and even deadly. If you experienced serious bleeding while taking Pradaxa, you may be eligible for compensation.

McGartland Law's knowledgeable legal team is happy to answer any questions you may have about a potential Pradaxa bleeding lawsuit. Contact McGartland Law today to schedule a free initial case consultation.