Have you been prescribed #rivaroxaban for #BloodClots?
A major trial of the anti-clotting drug rivaroxaban (XARELTO®) is now under scrutiny, after my BMJ investigation into the FDA's oversight of clinical trials.
maryannedemasi.substack.com/p/lancet-opens… @bmj_latest @rfsquared @drjohnm
A major trial of the anti-clotting drug rivaroxaban (XARELTO®) is now under scrutiny, after my BMJ investigation into the FDA's oversight of clinical trials.
maryannedemasi.substack.com/p/lancet-opens… @bmj_latest @rfsquared @drjohnm
Dubbed the "warfarin alternative," rivaroxaban has been prescribed more than 80 million times in the US alone. In 2020, it was rated 10th in the global sales rankings and generated almost US$7 billion that year.
The FDA identified numerous & serious data integrity deficiencies at 8 of the study’s 16 clinical trial sites. But when the trial was published in the Lancet in 2009 the investigators made no mention of the data integrity issues.
The lead investigator of the rivaroxaban trial said he was never made aware of the data integrity issues until I brought them to his attention in Oct 2022. Despite admitting to many flaws & missing safety data in the trial, he says the paper shouldn't be retracted from the Lancet
We presented @TheLancet with the FDA's review of the rivaroxaban trial, which concluded that the data were "unreliable". The journal has promised to investigate the matter further.
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