Medical Journal Says J&J Hid Problems from FDA in Xarelto Clinical Trial

Originally published by robertslawfirm.

The BMJ (formerly the British Medical Journal) has reported that Janssen Pharmaceuticals, a division of Johnson & Johnson, knew about a faulty medical device used during regulatory trials of Xarelto and withheld that information from the U.S. Food and Drug Administration (FDA). The device in question — INRation — was used to monitor patients using warfarin during the ROCKET AF trial. The INRation device was later shown to generate significantly lower results than traditional lab methods. The FDA used the ROCKET AF study to approve Xarelto, a popular anticoagulant used to treat atrial fibrillation, which is the subject of multidistrict litigation over failure to warn patients about dangerous side effects. Those side effects can include gastrointestinal bleeding, brain hemorrhages and stroke. According to The BMJ, Janssen set up a safety program to recheck data from the original trial following concerns about INRation, but did not share this information with clinical trial safety monitors. The INRation device was recalled in 2014 by the FDA. In addition, a new study published in JAMA Internal Medicine suggests that Xarelto users have a 15% higher risk of death, 65% higher risk of brain bleeds and 48% higher risk of major brain bleeds than Pradaxa users. Researchers reviewed data from almost 120,000 patients age 65 or older with nonvalvular atrial fibrillation that were using either Xarelto or Pradaxa to arrive at their conclusions. In 2013, the FDA recognized the label on Xarelto as misleading because it did not properly warn consumers of the risks associated […]

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