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Anti-Coagulant Xarelto Side Effect Reports Mounting

Sep 10, 2013

Mounting side effect reports have been received over the stroke prevention medication Xarelto, which is manufactured via a co-venture between Bayer and Johnson & Johnson.

In the first eight months of this year, 968 cases of adverse side effects associated with Xarelto were reported, including 72 deaths, according to Der Spiegel, citing Germany's Federal Institute for Drugs and Medical Devices (BfArM) data, wrote Reuters.

The number of Xarelto side effects including fatalities is up from 2012, when there were 750 reported cases of side effects, including 58 deaths. BfArM indicated that there is no confirmed link between Xarelto and adverse health reactions, Reuters reported.

Xarelto is one of Bayer’s key products and is expected to earn more than 2 billion euros ($2.63 billion) annually, according to Reuters. In fact, in the second quarter of 2013, Bayer earned 219 million euros in sales for the drug, tripling the amount earned in the same period for 2012. Meanwhile, according to FiercePharma, the growing injury and death reports appear to be tied to increased use of the drug.

Xarelto belongs to a new class of blood thinners that present increased bleeding risks that can cancel out the drugs’ benefits in patients diagnosed with Acute Coronary Syndrome (ACS). Xarelto is an Xa inhibitor, a type of oral anticoagulant that can increase by as much as threefold the likelihood that an ACS patient will suffer from severe bleeding. Drugs such as Xarelto were presented as an alternative to the long-used warfarin to prevent blood clots and strokes in people diagnosed with atrial fibrillation.

In fact, a prior study found that while a significant reduction in ischemic events was seen in all of the studies reviewed among patients taking the new generation of anti-coagulant drug therapies when compared to the placebo group, the study noted a threefold increased risk for a major bleeding event in patients taking factor Xa inhibitors, such as Xarelto, or a direct thrombin inhibitor after an ACS. According to the researchers, the bleeding risk almost completely negated the drugs’ benefits.

While warfarin—known by its brand name, Coumadin—can cause internal bleeding, there are readily available antidotes for warfarin bleeding. Warfarin requires regular blood monitoring or frequent doctor follow-up. Like any blood thinner, Xarelto can cause serious internal bleeding; however, unlike warfarin, there is no known antidote for Xarelto bleeding.

Prior research also found that a number of doctors interviewed by Reuters said they were hesitant to prescribe drugs such as Xarelto over concerns regarding the risk of stroke, serious bleeding, and blood clots, particularly in patients with poor kidney function. They said that patients using drugs such as Xarelto should undergo testing prior to taking the medications to ensure their kidneys are functioning well. The doctors also urged that patients should be educated about the drugs’ potential dangers and should be seen by doctors periodically, especially after a switch is made from warfarin.

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