In just the last four years, the FDA has raised many separate clarifications with Johnson & Johnson about the blood thinning drug Xarelto. These have included extra black box warnings about the possible contraindications, additional advertising requirements and further possible side effects that were not included on the original FDA approval in November 2011.
Despite the claim that it is simpler to prescribe and monitor then same-category anti-coagulant leader Warfarin, the case against using Xarelto and possible legal implications are mounting.
A January 2014 FDA notice highlighted that there isn’t an antidote to counteract excessive bleeding from the drug, and that this needed to be pointed out on the label.
This is significant from a number of angles. The first is that this is a big differentiator from Warfarin, which can be counteracted with certain plasma products and vitamin k.
In contrast, if a patient is administered Xarelto and experiences uncontrollable bleeding as a side effect, since there is no antidote, the patient’s death is a likely result.
A study published in the September 23, 2015 issue of Quarterwatch evaluated medical data from 2014 and highlighted that Xarelto accounted for more direct safety reports to the FDA, mostly from health professionals, than any other drug.
Direct reports to the FDA only account for 4.1% of the total of adverse drug effect reports received by the FDA in 2014, with the remainder coming directly from the manufacturers. The statistics indicate that problems need to be significantly greater before a medical professional will directly report to the FDA about adverse drug effects. As Xarelto has had more direct reports to the FDA, 525 for 2014, than any other drug, there is a general feeling that the likelihood of a significant percentage of these developing into legal cases is perhaps greater than for other medications, because they are independent of manufacturer spin and marketing and generally of a higher quality.
The anti-coagulant market that Xarelto is trying to compete in is a huge one, and has long been dominated by Warfarin, which was first approved for use back in 1956. It is also commonly used in hip and knee replacement surgery and for heart problems, which are some of the most common medical conditions and hence routinely diagnosed for millions of patients.
Quarterwatch reported that in 2014 there were 80,266,745 prescriptions for Warfarin and 1,758,016 for Xarelto. This marks the considerable lead that Warfarin has in the sector in terms of raw prescription numbers. However, considering that Xarelto costs 15 times as much ($3,000 a year compared to $200 for Warfarin) and has only been available since 2011, it is indicative of the giant steps this drug has taken in the blood thinning market.
It also has more prescriptions then the next two main ‘new coagulant class’ rivals combined (Dabigatran and Apixaban), and so making sure that its safety profile is acceptable becomes of much greater significance.
Taken together these factors are indicative of the potential for a much wider scale of problems with Xarelto, with the number of FDA direct reports showing the tip of a litigation iceberg destined to emerge in the future.