The only clinical trial for Xarelto that allowed it to gain approval for use in patients with atrial fibrillation to deter the development of blood clots has come into question. This clinical trial, known as ROCKET AF, compared patients using warfarin to patients using Xarelto. This clinical trial allegedly showed that Xarelto was no better than warfarin.
However, the effectiveness of warfarin is directly linked to whether the patient is getting the correct dosage of warfarin. During the ROCKET AF trial, Defendants chose to use a device to measure the amount of warfarin in the patient’s body that has now been recalled by the FDA because the device caused incorrect reading of warfarin levels in the patient’s body. Thus, a question has arisen whether the results of the ROCKET AF trial are valid because of incorrect use of warfarin during the trial.
The Food and Drug Administration is investigating whether the results of the ROCKET AF trial are still valid. In the Xarelto litigation, we are also demanding documents and taking depositions on this same issue. The validity of the ROCKET AF trial is a key question to whether Xarelto is safe and effective for use in patients with atrial fibrillation. We will continue to investigate this important safety issue.