Ongoing Study Indicates Pradaxa Side Effect Rates are Higher than Warfarin

According to the preliminary results of an ongoing study, the blood thinner Pradaxa is associated with a higher risk of complications than older anticoagulants like warfarin. At the 2012 Thrombosis and Hemotasis Summit of North America earlier this month, researchers from Alere, Inc. announced the preliminary findings of their study, which examined potential safety risks of new blood thinners like Pradaxa. According to the study’s findings, patients have to be removed from Pradaxa treatment due to complications more often than patients need to be removed from treatment with warfarin, with Pradaxa side effects occurring very early in treatment.

Warfarin vs. Pradaxa Blood Thinner

Coumadin, well-known by its genera name warfarin, is an older blood thinner typically prescribed to reduce the risk of blood clots and strokes in certain high-risk patients. In recent years, there have been increasing efforts to identify alternative therapies for this particular treatment, as warfarin requires extensive patient monitoring. Pradaxa (dabigatran) is the first of a new class of anticoagulant drugs and was originally introduced in the U.S. in October 2010. While Pradaxa has been touted as a superior alternative to Coumadin (warfarin) because it requires less monitoring, serious concerns have emerged about the risk of severe internal bleeding and other complications with Pradaxa use.

Death and Internal Bleeding Side Effects of Pradaxa

The blood thinner Pradaxa has been linked to a number of deaths and other complications caused by uncontrollable bleeding and hemorrhaging. In the preliminary findings of the Alere, Inc. study, researchers observed 2,200 patients on oral blood thinner therapy like Pradaxa and warfarin. According to researchers, the rate of complications among warfarin patients was 0.88%, while the rate of complications in Pradaxa patients was an alarming 11.5%. During the course of the study, only one patient on warfarin was hospitalized due to warfarin toxicity, while Pradaxa complications included one death from gastrointestinal (GI) bleeding, an instance of deep vein thrombosis, four other bleeding complications, a heart attack, a skin rash, a case of atrial thrombus, and four cases of GI problems so severe the patients were taken off the medication.

Pradaxa Lawsuits Filed for Bleeding Complications

In the midst of numerous post-marketing reports involving deaths and other internal bleeding side effects associated with Pradaxa, the FDA announced in December 2011 that it was reviewing the safety of the relatively new blood thinner. According to a report issued by the Institute for Safe Medication Practices in January 2012, more instances of bleeding complications with Pradaxa were reported to the FDA during the first quarter of 2011 than were reported in association with any other drug monitored by the group. At least 505 cases of Pradaxa bleeding side effects were reported, compared to 176 cases reported with warfarin, which was second on the list.

Legal Help for Pradaxa Side Effects and Deaths

A growing number of Pradaxa lawsuits have been filed in recent months by patients who alleged that Pradaxa maker Boehringer Ingelheim failed to adequately research their drug and to warn that severe bleeding complications caused by Pradaxa cannot be reversed like they can be with warfarin. If you believe you have been adversely affected by the blood thinner Pradaxa, our Pradaxa attorneys at Oklahoma Legal Center can help you understand your legal options in this matter. Our attorneys are experienced in handling defective drug cases and can help victims of potential Pradaxa side effects navigate through the sometimes difficult process of filing a drug injury claim against the allegedly negligent drug manufacturer.