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Research misconduct found by FDA often goes unreported in journals

March 6th, 2015

When the United States Food and Drug Administration (FDA) identifies research misconduct in often-quoted clinical trials, news of that misconduct is less likely to be reported, a study in the JAMA Internal Medicine finds. One particular Xarelto study is still quoted by Xarelto manufacturer Bayer Pharmaceutical in stating a case for the blood thinning drug’s safety, though the FDA has since tossed the study out due to research misconduct.

Xarelto study RECORD 4 was discredited by the FDA after the agency found falsified information in the reports, but the study was still published in The Lancet. The FDA reportedly also found issues with RECORD 2 and RECORD 3, though Xarelto manufacturer Bayer still cites the studies regarding information about Xarelto.

Xarelto has been linked to an increased risk of severe side effects, including deep vein thrombosis, pulmonary embolism and internal hemorrhaging. At least 183 deaths have been linked to Xarelto side effects, and more than 1,800 adverse events have been reported in the FDA’s Adverse Events Reporting System.

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