Manufacturer Seeks FDA Approval of Antidote for Blood Thinning Medication, Pradaxa®
According to recent reports, the German manufacturer, Boehringer Ingelheim, is seeking accelerated approval from the U.S. Food and Drug Administration (FDA) of an antidote for its anticlotting medication, Pradaxa®.
The antidote, idarucizumab, is a fully-humanized antibody fragment designed to reverse the anticoagulant effects of Pradaxa®. During a Phase I trial, the antibody showed immediate, complete, and sustained reversal of Pradaxa’s® bleeding effects. Boehringer is applying for a Phase III trial. The Pradaxa® manufacturer stated that idarucizumab is the first specific antidote for any new class of oral anticoagulants.
Pradaxa® is a blood thinning medication alleged to cause serious and uncontrolled bleeding events. In May 2014, Boehringer reached a $650 million settlement to resolve approximately 4,000 claims involving such injuries arising from Pradaxa® use. Another oral anticoagulant similar to Pradaxa® is Xarelto®, a blooding thinning medication that is facing recent lawsuits alleging the drug causes uncontrolled internal bleeding that may be irreversible.
The Pharmaceuticals and Medical Litigation Department at Schlichter, Bogard & Denton, LLP aggressively represent clients who allege to have suffered injuries as a result of dangerous pharmaceutical medications and unsafe medical devices. If you or a loved has suffered injuries as a result of dangerous pharmaceutical medications or unsafe medical devices, please contact the attorneys at Schlichter, Bogard & Denton, LLP toll-free at 1-800-873-5297 for your confidential and free consultation.
The choice of a lawyer is an important decision and should not be based solely on advertisements. The cases discussed do not predict outcomes in future cases. Past results afford no guarantee of future results and every case is different and must be judged on its own merits.