Last year, the United States Food and Drug Administration (FDA) became aware that a device used to monitor a patient’s blood in Xarelto clinical trials had problems. Now it has been reported by British Medical Journal, and via FiercePharma, that the two major drug companies (Janssen/Johnson & Johnson and Bayer A.G.) were well aware of this faulty blood monitor during the time it was being used and did not notify any of the study monitors or the FDA.
The device in question is known as the INRatio device, and it was designed to monitor how much Xarelto was being absorbed by patients on a single dose as compared to those who were taking Warfarin (Coumadin). The reason this is very important has to do with why drug makers claim Xarelto and the other New Oral Anticoagulants (NOACs) are safer and more effective than traditional blood thinning medications like Warfarin.
The reason they claim Xarelto is more convenient for patients is because you are not supposed to have to constantly be monitoring blood levels like you do with Warfarin. If you are not taking the correct dose of Warfarin, you could end up with a serious internal bleeding disorder. There are also certain foods like leafy greens that can contribute to the the dose being off. Meanwhile, the makers of Xarelto claimed that one dose was good for everyone, and there was no need for all this monitoring. However, in order to make these claims, they must do a series of clinical trials to determine if these claims are in fact true.
As it turns out, one type of machine used to monitor a patient’s blood was defective and was not providing researchers with accurate test results. What these allegations are claiming is that the company was well aware of the problems with the INRatio machine during the Rocket AF Phase III clinical trials and kept this information from the FDA.
As our Boston Xarelto injury lawyers have seen in far too many cases, the one-sized approach was not correct, and many people ended up with a serious internal bleeding disorder. However, unlike with Warfarin, doctors did not have a reversal agent (antidote), and there was often nothing these patients could do when they arrived at an emergency room with intracranial bleeding, for example. There is, however, now an antidote for a Xarelto competitor known as Pradaxa, with the antidote being called Praxbind, but that antidote is not approved for use in Xarelto patients. The company tried to develop a reversal agent of their own, but the FDA recently rejected the approval of this new drug for reasons that additional safety testing is required. With no cure, and no warning that patients will become very sick, thousands have been diagnosed with a serious internal bleeding disorder, and many have died as a result of this condition.
The reason people are taking these blood-thinning medications in the first place is because they suffer from a serious medical condition that does not allow them to clot properly, and this results in the formation of dangerous blood clots that can result in death.
If you are a victim Xarelto and live in Massachusetts, call the Law Offices of Jeffrey S. Glassman for a free and confidential appointment — 1-888-367-2900.
Johnson & Johnson hid faulty device concerns during key Xarelto study: BMJ, September 29, 2016, By Carly Helfand, FiercePharma
More Blog Entries:
Risk for Internal Bleeding after Taking Pradaxa, August 22, 2014, Boston Dangerous Drugs Injury Lawyer Blog