The rivaroxaban anticoagulant drug has been deemed safe for use by the U.S. Food & Drug Administration (FDA) after it generated controversies as to its efficiency and safety.
Rivaroxaban, a drug which was designed as a means of reducing the risk of strokes for patients suffering from atrial fibrillation, started raising questions after new information surfaced related to the trial study that was meant to show its efficiency.
The ROCKET-AF trial test, which was to compare the results of rivaroxaban versus the ones of warfarin, attracted attention last year after new data surfaced about the warfarin adjustment devices used in the trial, which were discovered to have been faulty. As the portable devices, which were supposed to adjust the level of warfarin, were called back after patients reported unreliable readings, rumors appeared that Johnson & Johnson knew about the faulty product, but decided to base their results on them.
Still, after a number of independent, separate studies, the FDA approved On Tuesday the use of Xarelto in the case of atrial fibrillation sufferers and deemed it an alternative to warfarin. Their results follow previous similar results in tests conducted by the ROCKET-AF investigators, the European Medical Authorities (EMA), and Johnson & Johnson (and Bayer) itself.
The FDA conducted tests followed the results of three different analyses conducted in the statistical, clinical, and clinical pharmacology areas. The warfarin device unreliable readings matter was especially analyzed and was found to feature an average lower value of 13% in trial test INR’s, as compared to laboratory conducted INR’s of the same stored samples.
Although a difference in numbers was registered, further investigation done by the FDA led to the conclusion that the efficacy of rivaroxaban would still outweigh its risks as the warfarin drug estimated reduction in terms of bleeding rates were small enough as to not invoke the need for a new testing. The clinical investigators also saw no need for any further major actions and saw no point in changing the label for rivaroxaban.
Whilst some like Sanjay Kaul, MD, who was a member of the advisory panel assembled in order to re-evaluate the ROCKET-AF, seem to be satisfied and trust the results others, like BMJ investigator Deborah Cohen, still express concerns and do not fully agree with the final decision.
Cohen chose to analyze the matter also from an ethical point of view and questioned the FDA choice of acceptable risk to benefit ratio view as she further questioned Janssen’s apparent availability to have its trial patients pass through possible major bleedings.
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