Xarelto Legal Action: The Real Cost of a Test-Free Alternative

Published on July 2, 2015 by

Xarelto's strongest selling point was that patients wouldn't have to undergo frequent blood tests while on the drug. But although the U.S. Food and Drug Administration (FDA) didn't require blood testing for Xarelto users, its review of Xarelto highly recommends it.

According to the FDA review itself, "While it is convenient for patients to dispense with the monthly monitoring required by Warfarin, infrequent monitoring (perhaps at initiation and then yearly) to assure appropriate dosing of the drugs that prevent stroke and cause bleeding may improve outcomes and be acceptable to patients."

What's most perplexing about this discovery is that, had Xarelto manufacturers implemented these guidelines, the drug would have still carried a significant advantage over its biggest competitor, Warfarin. More importantly, directing doctors to require this simple blood test could have significantly improved patient safety.

The FDA further stated, in its initial 2011 review of Xarelto, that "[Xarelto manufacturer] has not chosen to utilize this information. In fact, so far as we are aware, none of the other manufacturers/sponsors of other oral anticoagulants that inhibit single coagulation factors have chosen to utilize pharmacokinetic/pharmacodynamic information to explore adjusting dose to optimize safety and efficacy."

This statement is perhaps unsurprising in light of the alarming number of lawsuits filed against similar anticoagulant manufacturers, some of which have been cited in this book. However, it also raises questions about the reliability of the FDA as a whole. In our next blog we will discuss the role of the FDA.

For more information regarding the harm of Xarelto, download a copy of our free E-book, The Xarelto Disaster: How Johnson & Johnson Failed to Warn Consumers of Deadly Internal Bleeding Risks or contact our experienced legal team to discuss your particular issue with Xarelto by calling 855-423-3666.