Increasing reports of side effects associated with the anti-stroke medication, Xarelto, are being received. Xarelto is manufactured and marketed by Bayer and Johnson & Johnson.
From January to August of 2013, 968 cases of adverse side effects tied to Xarelto were received, including 72 cases of fatalities, according to Der Spiegel, citing Germany’s Federal Institute for Drugs and Medical Devices (BfArM) data, Reuters reported.
The number of Xarelto side effects and fatalities has increased this year over 2012 when 750 side effect reports, including 58 reported deaths, were received. Yet, according to the report, BfArM stated 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 the second quarter of 2013, Bayer earned 219 million euros in sales for Xarelto, three times more than the same period in 2012. According to FiercePharma, the growing injury and death reports appear to be tied to Xarelto’s increased use.
Xarelto is among a new class of blood thinners that is associated with increased bleeding risks that may counter any benefits in patients diagnosed with Acute Coronary Syndrome (ACS). Xarelto is an Xa inhibitor, a type oral anticoagulant that can potentially increase the likelihood that an ACS patient will suffer a serious bleeding event by as much as three-fold. Drugs, such as Xarelto, were believed to be an alternative to the long-used warfarin in the prevention of blood clots and strokes in people diagnosed with atrial fibrillation.
A prior study revealed that, although significant reduction in ischemic events was seen in the studies reviewed among patients taking the new generation anti-coagulant therapies, when compared to the placebo group, a three-fold increased risk for a major bleeding events in patients taking factor Xa inhibitors, such as Xarelto, or direct thrombin inhibitor, after an ACS was seen. The researchers indicated that the bleeding risk almost completely negated the drugs’ benefits.
While warfarin—known by the brand name Coumadin—can lead to internal bleeding, there are antidotes available for warfarin bleeding reactions. Warfarin calls for regular blood monitoring or frequent doctor follow-up. Like any blood thinner, Xarelto can cause serious internal bleeding; however, where a warfarin bleed can be stopped with the proper treatment, there is no known antidote for Xarelto bleeding.
Prior research revealed that a number of doctors interviewed by Reuters said they were hesitant to prescribe medications such as Xarelto due to concerns of the risks for stroke, serious bleeding, and blood clots, particularly in patients diagnosed with poor kidney function. The physicians said that patients using drugs such as Xarelto should undergo testing before taking the medications to ensure their kidneys are functioning properly. 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.