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FDA To Launch Safety Assessment Of Pradaxa Blood Thinner

7 January 2014No Comments

PradaxaSince Boehringer Ingelheim’s Pradaxa drug garnered FDA approval in the United States in 2010, serious concerns have been raised about the safety of the popular anticoagulant. At the top of the list of safety concerns is the absence of a reversal agent for Pradaxa (dabigatran), which has been marketed by Boehringer as a superior alternative to older blood thinners like warfarin, whose blood thinning effects can be reversed by the antidote vitamin K in the event of hemorrhage or internal bleeding complications. There is no such reversal agent for Pradaxa, however, and the anticoagulant has been tied to life-threatening bleeding side effects that doctors are unable to control. In light of these alleged Pradaxa side effect risks, officials with the FDA have announced their plan to conduct a new safety assessment of the medication compared to its top competitor, warfarin.

Assessing the Rate of Pradaxa Complications

On December 30, 2013, the FDA posted a request for public comment on a proposed protocol of the Pradaxa study, which the agency describes as “a one-time assessment of selected safety outcomes in adults with atrial fibrillation who are new users of dabigatran or warfarin.” The large-scale study will “assess systematically the rates of bleeding and thromboembolic outcomes associated with the use of dabigatran and warfarin for patients with atrial fibrillation using data from the FDA Mini-Sentinel Distributed Database (MSDD).” The Mini-Sentinel project uses preexisting electronic healthcare data from multiple sources, according to the FDA, and involves nearly 100 million patients.

Patients at Risk for Alleged Pradaxa Side Effects

Although the FDA stated in a November 2012 report that bleeding rates tied to Pradaxa were no higher than with warfarin, the newer blood thinner has faced persistent safety concerns over the alleged risk of internal bleeding side effects and death. The main purpose of the Pradaxa study will be to identify groups of patients who are at high risk for serious bleeding events with Boehringer Ingelheim’s blockbuster blood thinner. Although the drug company maintains that the upcoming safety assessment of Pradaxa “does not necessarily mean there is a safety issue with the product,” the fact that the FDA’s assessment focuses solely on Pradaxa will likely reinforce concerns about the potentially dangerous anticoagulant.

Contact Our Pradaxa Attorneys for Legal Help

In its announcement of the Pradaxa safety assessment, the FDA noted that “Questions remain about the outcomes associated with dabigatran outside of the clinical trial setting and in typical clinical practice populations.” This is largely due to the prevalence of serious and possibly even fatal bleeding complications that have been linked to Pradaxa in recent years. Between March 2008 and October 2011, for example, Boehringer Ingelheim confirmed 260 fatal bleeding events associated with Pradaxa worldwide. If you took Pradaxa in the past and you have since suffered a major complication like internal bleeding or hemorrhaging, contact our knowledgeable attorneys at Bandas Law Firm for legal help. Our law firm is located in Corpus Christi, and our product liability lawyers have extensive experience handling Pradaxa side effect claims.


Posted Under: Drug Litigation