Pradaxa Bleeding Risks Offset Health Benefits for ACS

September 28, 2012 — Researchers have found that the new blood-thinning drugs Pradaxa (dabigatran), Xarelto (rivaroxaban), and Eliquis (apixaban) have severe risks of bleeding that offset any health benefit for patients suffering from Acute Coronary Syndrome (ACS) — a life-threatening condition caused by sudden reduced blood flow to the heart.

The study, published in the Archives of Internal Medicine, compared the effectiveness and safety of new blood-thinning drugs versus a placebo. The new drugs included Pradaxa, Xarelto, and the experimental drug Eliquis, which has not yet been approved by the FDA.

The researchers conducted a meta-analysis of seven different studies, which involved more than 31,000 patients who were given either a placebo or a new type of blood-thinning drug. They found that patients who were given a blood-thinning drug had a tripled risk of a bleeding event, but no benefit for patient survival rates.

The drugs slightly reduced the patients’ risk of a blood clot (thrombosis). However, the researchers cautioned: “Despite receipt of dual antiplatelet therapy, patients after an ACS remain at significant risk for thrombotic events.”

The authors of the study wrote:

“For net clinical benefit, treatment with new-generation oral anticoagulant agents provided no advantage over a placebo. The use of anti-Xa or direct thrombin inhibitors is associated with an increase in major bleeding events, which might offset all ischemic benefits in patients receiving antiplatelet therapy after an ACS.”

The authors of the study also noted that several studies had to be halted prematurely due to adverse events.

Pradaxa (dabigatran) is a direct thrombin inhibitor, which inhibits an enzyme that allows blood to coagulate. Xarelto (rivaroxaban) and Eliquis (apixaban) are both Xa-inhibitors.

Since Pradaxa was approved in 2010, there has been growing criticism about the way this drug was marketed. Some doctors have raised concerns that prescribing physicians were not fully informed that Pradaxa has no quick reversal mechanism. In an emergency bleeding event, a patient may require hours of dialysis to stop the bleeding. By the time Pradaxa is removed from the bloodstream, a patient could be severely injured. The alternative to Pradaxa, warfarin (Coumadin), has been in use for decades and can be reversed with a dose of Vitamin K.

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