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Report questions FDA approval of controversial anticoagulant

BMJ 2015; 351 doi: https://doi.org/10.1136/bmj.h5557 (Published 19 October 2015) Cite this as: BMJ 2015;351:h5557
  1. Michael McCarthy
  1. 1Seattle

Officials of the US Food and Drug Administration lowered its standards to ease approval of the controversial anticoagulant dabigatran (marketed as Pradaxa) and then deflected questions about its safety that arose after the drug entered clinical practice, an independent watchdog group has alleged in a new report.1

In its report the Project on Government Oversight claimed that the FDA gave in on such issues as the standards that the clinical trial used to secure the drug’s approval and what warnings patients should be given about the drug’s potential hazards.

“In judgment call after judgment call involving the prescription blood thinner Pradaxa . . . the FDA took a lax or permissive approach,” the report said.

The drug, manufactured by Boehringer Ingelheim, was approved by the FDA in 2010 to prevent blood clots in patients with atrial fibrillation, a common complication that can lead …

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