So many patients who were prescribed Pradaxa to replace Warafin (Coumadin) for stroke prevention could bleed to death, since there was no reversal agent known. Pradaxa was easier to take and required less medical monitoring; however, the drug caused excessive bleedings without warning, causing many serious injuries – and even death of innocent patients. Unlike Warafin, which has vitamin K as a reversal agent, there has not been a reversal agent to date for use with Pradaxa, making it a very risky drug.
However, according to the results of an early trial presented this week, researchers may have finally identified a reversal agent for Pradaxa! Although it is not yet approved, a study was conducted in which men were given this medication for four days, then provided with an intravenous drip containing either the potential new reversal agent or a placebo. Those receiving the new antidote had a complete reversal of Pradaxa’s anti-coagulation effects following a five-minute infusion of the agent.
In December 2011, the U.S. Food and Drug Administration (FDA) first announced a safety review of the drug. Pradaxa is a blood thinner used by patients with heart problems such as atrial fibrillation (irregular heartbeat). An exorbitant number or adverse drug reports were received. In 2011, the FDA received about 3,781 reports involving serious injuries associated with the use of Pradaxa, which included 2,367 reports of hemorrhage and 542 deaths.
In 2012, reports decreased, however, the total number of deaths were up. At least 3,292 adverse reports were received, including at least 582 deaths.
The maker of Pradaxa, Boehringer Ingelheim, has not indicated when the reversal agent may become available, but this may have a major impact on sales for the company. Despite concerns of uncontrollable bleeding, the company made over $1.43 billion in sales last year.
Although this is big news for the drug maker, it is great news for Plaintiffs involved in Pradaxa lawsuits, which currently exceed 1,500. The news of a possible reversal agent will most likely reinforce Plaintiff’s claims the Boehringer Ingelheim failed to adequately research the medication before making it available to consumers. Lawsuits allege that individuals suffered severe and sometimes fatal injuries after their doctors were unable to reverse the effects of Pradaxa, accusing Boehringer Ingelheim of failing to adequately warn about the risk of uncontrollable bleeding or lack of an antidote to reverse the side effects of Pradaxa. Some Pradaxa lawsuits are preparing for early trial dates, scheduled to being in August, 2014.
We will continue to keep you updated as more on this reversal agent develops. For more information, feel free to contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).