Another Blood Thinner Prompts Concerns Over Serious Injuries

As Pradaxa lawsuits continue to mount, the newest blood thinner approved by the FDA, Xarelto (rivaroxaban), is also prompting concerns over its reported side effects. According to the Institute for Safe Medication Practices (ISMP), in the first quarter of 2012 there were at least 356 reports of serious, disabling, or fatal injury in which Xarelto was the primary suspect drug. The report total more than doubled from the previous quarter’s total of 128 cases. Worrisome is that the most frequently-reported adverse effect was pulmonary embolism, the exact dangerous condition Xarelto was approved to prevent.

Interestingly, the problems of Xarelto have most severely affected a different age group than Pradaxa.

In 2011, the FDA approved Xarelto to prevent blood clots in patients undergoing knee or hip replacement surgery and for people with atrial fibrillation The FDA recently used a priority approval process to approve Xarelto for wider usage than Pradaxa, expanding its reach to treat two kinds of blood clots, deep vein thrombosis and pulmonary embolism. Like Pradaxa, Xarelto requires no dose individualization or regular blood testing, which makes it a more attractive choice than its predecessor Coumadin (warfarin).

Interestingly, the problems of Xarelto have most severely affected a different age group than Pradaxa. According to the recent report by the ISMP, while Pradaxa adverse reactions predominantly involved reported hemorrhages in older patients with atrial fibrillation (median age 80), the largest group of Xarelto cases involved the development of severe blood clots in younger patients (median age 66) taking the anticoagulant drug after hip or knee replacement surgery.

Xarelto’s manufacturers, Janssen Pharmaceuticals (owned by Johnson & Johnson) and Bayer, reports that it believes the number of adverse reports is not more than might be expected from a newly launched drug and a high-risk, post-operative patient population. Bayer is also doing research to find out whether Xarelto could reduce the chance for major cardiac events in patients with coronary artery or peripheral artery disease in combination with aspirin.