A recent report in the Journal of the American Medical Association (JAMA) suggests that risks, including uncontrolled bleeding, associated with the anticoagulant Pradaxa raise enough concern that the drug should have been subject to stricter scrutiny than the speedy approval by the Food and Drug Administration.
Pradaxa was one of 16 drugs approved last year under the FDA's expedited approval programs, which are subject to a shortened study period Pradaxa was indicated to reduce the risk of stroke adn blood clots in patients with a heart condition called atrial fibrillation (irregular heart beat).
Unlike Pradaxa's predecessor warfarin — another blood-thinner also used to prevent stroke — Pradaxa has no antidote to stop uncontrollable bleeding, according to the September 5, 2012 JAMA report by Thomas J. Moore and Curt D. Furberg. Bleeding caused by warafrin can be countered by the introduciton of vitamin K. Patients who begin bleeding with Pradaxa must undergo dialysis — a time-consuming process. Injuries linked to Pradaxa bleeds have included cerebral hemorrhage, kidney bleeds and heart attacks, the report states.
If you or someone you know has suffered injury while taking Pradaxa, call the attorneys at Sheller, P.C. to discuss your legal rights (800) 883-2299, or visit us online at www.sheller.com.