Xarelto (Rivaroxaban) Side Effects: Increased Bleeding?

Blood thinner Xarelto prevents recurrent heart attacks
Physicians may soon add a new blood-thinning drug called Xarelto (rivaroxaban) to the standard treatment for people with “acute coronary syndrome”—and in doing so lower their risk for a subsequent heart attack or stroke, or death.

Acute coronary syndrome (ACS) is an umbrella term covering the conditions of angina and a prior history of heart attack.

“It seems a good chance that the drug will soon be approved for treatment following an acute coronary syndrome,” said Dr. Simeon Margolis, on Dec. 9 in his blog, “Your Best Health After 50” published regularly by Yahoo! Health.

Dr. Margolis, a professor of both medicine and biochemistry at the Johns Hopkins School of Medicine, made this prediction following the results of a new study that found Xarelto effectively lowered the risk of subsequent heart attack, stroke or death in people who suffered ACS.

The clinical trial found that taking Xarelto, twice daily by mouth, reduced deaths from heart attacks and strokes by 9.1 percent.

The study was published last month in the New England Journal of Medicine and its findings were reported during the annual meeting of the American Heart Association in Orlando, Florida. The drug’s makers, Johnson & Johnson and Bayer Healthcare, funded the study.

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According to Dr. Margolis, the new study is a critical because Xarelto works differently from current drug thinners, which prevent blood clots by addressing only one of the two causes of clotting.

In contrast, Xarelto addresses both causes of clotting, in this way increasing the chances that a person taking the drug will not suffer a recurrent heart attack, he said.

“Heart attacks and strokes occur when a blood clot blocks the blood supply to a portion of the heart or brain. This clot, called a thrombus, forms at a site where there’s been a rupture of plaque within an artery,” Dr. Margolis explained.

Blood clots result when blood platelets aggregate or when the coagulation system is set off, or when both happen, and current blood thinners like clopidogrel (Plavix) and prasugrel (Effient) or aspirin used as a blood thinner, only prevent blood clots by stopping platelet aggregation, he said.

In contrast, the new drug works by “halting one of the many events in the complex cascade of reactions that leads to the coagulation of blood,” he added.

“Using rivaroxaban after an ACS would provide the first opportunity to treat these medical emergencies with drugs that help with both platelet aggregation and coagulation factors,” Dr. Margolis said.

ACS is a common condition and is one of the most frequent reasons for hospitalization worldwide. Every year, around one million people in the United States are hospitalized for the condition.

New promise for heart patients
The new research trial covered 15,526 people who had been hospitalized for ACS. Researchers gave participants either a low dose (5 mg) or a very low dose (2.5 mg) of the new blood thinner or a placebo, on top of standard care. Both were given twice daily for an average of 13 months.

The study showed that people who received either dosage of Xarelto had a lower risk of heart attack, stroke or death than their counterparts who were given a placebo.

Specifically, there was a 16 percent decrease among patients in the 2.5-mg group and a 15 percent decrease in the 5-mg group, researchers reported.

Among the participants taking the 2.5-mg dose, there was a 34 percent reduced risk of cardiovascular death and a 32 percent lower risk for death from any cause. Similar reductions were not seen among people taking the 5-mg dose, however.