Two studies published in 2013 and 2014 indicate that the risks of gastrointestinal bleeding in patients taking Pradaxa (dabigatran) may be higher than the risks faced by patients who take another blood-thinning medication such as Coumadin (warfarin).
In 2011, the Food and Drug Administration (FDA) approved Pradaxa to help prevent blood clots and strokes in patients with non-valvular atrial fibrillation, a common type of heart rhythm problem. In 2012, the FDA announced an investigation into incidents of internal bleeding suffered by patients who took Pradaxa. Although the FDA noted that clinical trials comparing Pradaxa to other blood thinners showed similar bleeding risks, the agency stated that it was looking into whether the risks on Pradaxa were actually higher than the trials had indicated.
A July 2014 study published in the BMJ indicated that when patients take Pradaxa, they may face a higher risk of severe bleeding problems, but that more frequent blood testing may help doctors prevent such problems before they cause major injuries. In October 2014, a study published in the journal Circulation indicated that while Pradaxa patients had a lower risk of certain kinds of stroke when compared to Coumadin patients, they had a higher risk of major stomach bleeding. The risk increased when patients were given higher doses of Pradaxa.
At Wingate, Russotti, Shapiro, Moses & Halperin, LLP, our experienced New York defective drug attorneys can help you determine what happened to you and fight for the compensation you deserve. If you’ve suffered serious side effects after taking Pradaxa or another medication, contact us today for a free and confidential case evaluation.