Pradaxa® (dabigatran) was approved by the FDA in 2010 as an anticoagulant for reducing the risk of stroke in patients with non-valvular Atrial fibrillation (AF or A-fib). Since approval, Pradaxa has been linked to several deaths and reports of severe bleeding.
In December 2011, the FDA began a formal investigation into reports of Pradaxa injuries resulting in death. There has been over 260 reports of fatalities while on Pradaxa and several other injuries associated with the anticoagulant including severe bleeding. The FDA is investigating whether the incidence of bleeding among patients prescribed Pradaxa is higher than what would be expected based on the Pradaxa clinical trials.
The most serious side effects associated with Pradaxa include internal bleeding that can lead to death. Patients taking Pradaxa sould be aware of the signs and symptoms of internal bleeding.
Pradaxa is manufactured by the German based pharmaceutical company Boehringer Ingelheim GmbH. The company reported last week that it expects sales to rise by a high-single-digit percentage this year as a partial result of its sales of Pradaxa. Boehringer said its sales grew 5% to EUR 13.2 billion.
Attorneys at Schlichter Bogard and Denton, LLP, are investigating claims associated with Pradaxa for individuals who have experienced brain hemorrhage, severe bleeding, and for families who have lost a loved one after taking Pradaxa.
If you or someone you know has been injured by Pradaxa please contact the product liability lawyers of Schlichter Bogard & Denton today to discuss your case.