Health Risks of Pradaxa, Xarelto Investigated by American Stroke Association

A group of stroke experts has indicated that they are reviewing the safety of Pradaxa and other similar blood thinners, as they attempt to get a better idea of what the new drugs will mean to health and stroke risks. 

The report is being conducted by the American Stroke Association (ASA) and will focus on Pradaxa, Xarelto and other new generation anticoagulants that are competing to replace Coumadin, known generically as warfarin.

The ASA is taking on the subject as concerns over the side effects of Pradaxa continue to rise amid a large number of reports involving serious bleeding events and deaths during the first year the medication was on the market.

The report, “Novel Anticoagulants for the Prevention of Stroke in Atrial Fibrillation” will be a science advisory by a panel of scientists and doctors headed by Dr. Karen Furie, director of stroke service and prevention at Massachusetts General Hospital, Boston, and Dr. Larry Goldstein, director of the Duke Stroke Center.

Pradaxa (dabigatran) was introduced by Boehringer Ingelheim in October 2010, as the first of a new class of anticoagulants known “direct thrombin inhibitors”, which inhibit the enzyme in the blood that causes blood to clot. The medication was promoted as a superior alternative to Coumadin for prevention of strokes among individuals with atrial fibrillation.

Xarelto (rivaroxaban) was introduced in November 2011, as the second drug in this new class. The FDA approved the medication despite staff recommendations against the medication, after independent advisory committee voted 9-2-1 to recommend approval of the medication for stroke prevention in atrial fibrillation.

Within months of Pradaxa’s introduction, the medication became widely used because it was marketed as easier to use, since it did not require the same monitoring for bleeding associated with Coumadin. However, when serious bleeding events do occur with Pradaxa, they can not be quickly counteracted by doses of Vitamin K like with Coumadin, which some experts suspect may be the cause for the high number of Pradaxa deaths.

According to a report released by the Institute for Safe Medication Practices in January 2012, more instances of hemorrhages with Pradaxa were reported to the FDA’s Adverse Event Reporting System during the first quarter of 2011 than were reported in association with any other drug monitored by the group.  At least 505 instances involving Pradaxa bleeding problems were reported, compared to 176 cases reported with warfarin/Coumadin, which was second on the list.

A number of individuals throughout the United States are now considering a Pradaxa lawsuit against the drug maker for failing to adequately research the medication or warning about the risk of serious and potentially life-threatening health risks of Pradaxa.