FDA Reassesses Pradaxa among Safety Concerns

FDA Reassesses Pradaxa among Safety Concerns | Pintas & Mullins Law Firm

Since its introduction in 2008, the blood-thinning drug Pradaxa has garnered a lot of attention surrounding its safety. In light of these concerns, the FDA recently announced it will soon perform a large-scale analysis of the drug and how it compares to its rival, warfarin. Pradaxa attorneys at Pintas & Mullins Law Firm anxiously await this overdue analysis, and encourage patients prescribed to Pradaxa to report any injuries or adverse events as soon as possible.

The agency’s reassessment is preceded by a call for public comment, published here, on the analysis’ protocol. The public is allowed to post opinions until Monday, January 13, 2014. Pradaxa will be subject to a one-time safety outcome assessment in patients with atrial fibrillation. The study will focus primarily on comparisons between Pradaxa (dabigatran) and warfarin, with particular attention paid to intra- and extra-cranial hemorrhages and ischemic strokes.

Pradaxa was developed by Boehringer Ingelheim to rival warfarin (also known as Coumadin), which has been the blood-thinning drug of choice for several decades. When Pradaxa was put on market, it quickly gained blockbuster status, a category reserved only for drugs that reap over $1 billion in sales. The drug caused nearly 550 deaths in the U.S. in 2011 alone, prompting uproar of criticism over the process through which it was approved.

The Problem with Pradaxa

Unlike warfarin, if a Pradaxa patient begins bleeding, there is no known remedy to stop it. An elderly patient on Pradaxa may suffer a minor fall at home, be admitted to the hospital alert and coherent, and pass away several hours later from bleed-out. Doctors become helpless, forced to watch otherwise healthy patients suffer fatal bleeding episodes with nothing to heal them.

The clinical trials conducted for Pradaxa’s approval were tightly controlled, and produced nearly identical rates of bleeding compared to warfarin. Despite the very clear lack of antidote, the FDA approved Pradaxa. Warfarin can be reversed by vitamin K or other similar substances, however it requires close patient monitoring and adherence to a strict diet and blood work schedule.

Patients prescribed to Pradaxa and warfarin are diagnosed with a cardiac disorder known as atrial fibrillation, which affects the rhythm of the heart. The drugs are intended to prevent strokes, and hundreds of thousands of patients are now prescribed Pradaxa over warfarin because of its less regimented schedule and ability to prevent strokes. The risks, it seems, do not always outweigh the benefits, particularly in two subsets of patients: those with kidney problems and the elderly.

The risk of fatal bleeding is significantly higher in these two patient cohorts, however, they continue to be prescribed Pradaxa in high numbers. This has prompted a slew of lawsuits against Boehringer Ingelheim and medical malpractice cases against physicians who negligently prescribed the drug despite its severe risks. 

At present, the drug manufacturer claims it is actively researching antidotes for Pradaxa; in the meantime, emergency rooms are urged to treat Pradaxa bleeding patients with dialysis in order to clear the drug from the patients’ system. There is no studied basis for the efficacy of this treatment, however. Consequently, physicians throughout the country are pushing for the drugs’ recall, or at the very least, severe curtail of its prescription.

Pradaxa attorneys at Pintas & Mullins Law Firm will report on the results of the FDA assessment as soon as they become available. If you or a loved one suffered a major bleeding event with Pradaxa or any other similar anticoagulant drug, contact our firm immediately. We offer free legal consultations to potential clients nationwide, and can help guide you through the process of filing a claim against the drugs’ manufacturer.