FDA Safety Update on Pradaxa Insufficient, Reports Suggest


FDA Safety Update on Pradaxa Insufficient, Reports SuggestOverview: The U.S. Food and Drug Administration (FDA) has issued a new safety update on Pradaxa. After investigating the rates of gastrointestinal and intracranial hemorrhaging associated with the blood thinner, the FDAs stated that the rate of bleeding events linked to Pradaxa are no higher than those associated with warfarin. The review was conducted following “a large number of post-marketing reports of bleeding among Pradaxa users”, the agency said. According to reports in the New York Times and Forbes, the FDA failed to mention serious safety issues associated with the drug.

  • FDA analysis finds that Pradaxa has similar rates of bleeding compared to warfarin
  • The new update does not mention the lack of an antidote for Pradaxa, which has led to fatal uncontrollable bleeding in some patients
  • A Forbes report takes issue with the methods used

Product: Pradaxa® (dabigatran)

Manufacturer: Boehringer Ingelheim Pharmaceuticals

Side Effects & Complications

  • Cerebral hemorrhaging
  • Gastrointestinal (GI) hemorrhaging
  • All types of bleeds including the intraspinal, intraocular, intraarticular (joints), retroperitoneal or pericardial areas

FDA Safety Update Lacking, Reports Suggest

On Friday, the FDA issued a Drug Safety Communication stating that “bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin,” The agency said that it is continuing to evaluate data for the ongoing safety review of Pradaxa. The update did not mention the fact that Pradaxa lacks an antidote, an issue that has spurred a number of safety concerns. Unlike warfarin, there is no way to stop the bleeding in a Pradaxa patient. Dr. Richard H. Schmidt told the New York Times, “The practical experience is that once hemorrhagic complications occur in this drug, it is much more likely to be a catastrophe than with Coumadin,” Dr. Schmidt is an associate professor of neurosurgery at the University of Utah; he treated a Pradaxa patient who died of bleeding.

An article in Forbes suggests that the method used to conduct the FDA analysis was flawed. The agency used unadjusted incidence rate ratios to evaluate the rates of gastrointestinal and intracranial hemorrhages; this data was gathered using the FDA’s Mini-Sentinel pilot, which is based off insurance claims and administrative data. According to Forbes, the Observational Medical Outcomes Project (OMPO), which was partially set up by the FDA, found that this method “performs poorly”. Additionally, “data presented at an OMOP symposium in June suggest the Pradaxa analysis pursued by Sentinel may be problematic.” Forbes reports.


The FDA approved Pradaxa in 2010 using an expedited review process. A recent report in the Journal of the American Medical Association used Pradaxa as a primary example of how this type of approval can expose patients to serious safety risks.

Last December, the FDA began evaluating post-marketing reports of serious bleeding events associated with Pradaxa. The review followed reports of the deaths of some 260 Pradaxa patients in a European database. A recent report by the Institute for Safe Medication Practices found that there were more adverse event reports linked to Pradaxa than  any other drug last year.