I, like most people, tend to want to believe that the advancements in prescription drugs which have enabled us, in general, to live longer, healthier lives, along with our own regulatory bodies, namely the United States Food and Drug Administration, mean that the drugs that should help us – the drugs our doctors prescribe – are doing exactly that. Helping.

After talking with Ned McWilliams, a lawyer with the law firm of Levin, Papantonio, about the Atrial Fibrillation drug Xarelto, I realize that in many cases the opposite is happening – that users across the United States are experiencing an array of side effects, the most severe of which is uncontrollable bleeding and even death.

What is Xarelto?

For those who don’t know, Xarelto is one of a new generation of anticoagulant stroke drugs for patients with non-valvular anti-fibrillation which are marketing themselves as the more lifestyle-friendly replacement for the drug wafarin. Simply put, for those in danger of blood clots, these drugs thin their blood and prevent strokes.

For more than 50 years, warfarin has been the only anticoagulant therapy available for the treatment for Atrial Fibrillation, and, from what I understand from Ned McWilliams, users found Xarelto’s ease of use immediately appealing. Warfarin has a less marketable pharmacokinetic profile, one which requires routine blood testing and dose adjustments for safe and effective use.

Talking to me from Levin, Papantonio, Ned explained:

“This blood-testing requirement is a significant factor in warfarin limited demographic reach. In order to make effective anticoagulant therapies more readily available to the wider public, the United States Food and Drug Administration fast tracked the approval process for this new generation of anticoagulant drugs like Xarelto and Pradaxa.”

The big numbers and troubling discoveries around new anticoagulant therapies

Xarelto, designed by pharmaceutical giant Bayer Healthcare and currently sold in the United States through a licensing agreement with Jansen Pharmaceuticals (a division of Johnson and Johnson), was introduced in 2011 – following the successful launch of Pradaxa – to a fanfare of marketing. It has since delivered nearly $1.5 billion a year in sales according to a September 3, 2014 report. Yet, as early as 2011 evidence began mounting of irregular, sometimes uncontrollable bleeding – even deaths – connected to the drug.

A recent investigation by the British Medical Journal (BMJ) revealed that the makers of Pradaxa, Boehringer Ingelheim, have conducted analyses “indicating that major bleeding events could be significantly reduced if patients were dosed based upon the results of a single blood test (measuring the concentration of drug in the blood of an individual patient) versus based upon patient characteristics as is currently recommended in the Pradaxa (and Xarelto) labeling.” Reading this over, it amazes me – it seems that these events of uncontrollable bleeding could be significantly reduced with the use of one simple drug test.

How one simple change could have made an enormous difference

In reporting the U.S. Food and Drug Administration’s (FDA) review of Xarelto, the FDA acknowledged the benefit patients could have from blood-test-based optimized dosing during its review. 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.” (3)

In short, should the manufacturers of Xarelto have directed doctors to require a simple blood test for Xarelto users, they could have significantly improved patient safety. The makers of Xarelto are unwilling and the regulators are unable to make such a recommendation. Addressing the scientific evidence regarding the use of a blood test to improve patient safety, the FDA stated that “[the makers of Xarelto] 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.” (4)

Equally troubling? The lack of authority that the FDA has to require manufacturers to investigate and test patients for what would be deemed the proper dosage; this as the concerns regarding Xarelto’s safety continue to rise. Though FDA regulators may not have the authority to demand an improvement in patient safety through blood-test-based-dose-optimization, those in the medical community and the market it serves do. A growing chorus of physicians and scientists are calling for this kind of testing to optimize dosing in patients.

Uncovering and discovering on the Xarelto lawsuit

I spoke with Ned McWilliams because Levin, Papantonio is one of the first in the U.S. to file a Xarelto lawsuit, and there are others following in their path. They are in the early stages of their investigation, but from what I understand, what they are discovering is only looking worse. At every turn they are finding more information about incidences of avoidable uncontrollable internal bleeding.

Given the refusal of the manufacturers and marketers of Xarelto to greatly improve the safety of the drug with one, infrequent test or to make the danger of its side effects clear, it’s only natural that, although these companies have helped us believe that “first do no harm” applies to them, sometimes we really have to question their motives.

[1]  http://www.fiercepharmamarketing.com/story/jj-bayer-look-turbocharge-xarelto-new-label-expanding-studies/2014-09-03?utm_medium=nl&utm_source=internal

[2]  http://www.bmj.com/content/349/bmj.g4670

[3]  FDA Summary Review Xarelto 11/4/11 pg. 9

[4]  FDA Summary Review Xarelto 11/4/11 pg. 9

Ellen Barnett is a guest contributor to Ring of Fire.