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FDA Investigating Pradaxa Related Bleeding Events

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Jarod Cassidy3 years ago

The U.S. Food and Drug Administration (FDA) has recently completed an analysis comparing the safety of Pradaxa to warfarin with mixed results.

About the Pradaxa Study

The study reviewed medical records from over 134,000 Medicare patients aged 65 years or older in an attempt to determine if treatment with Pradaxa was safer than treatment with warfarin.

Both Pradaxa and warfarin are blood thinners used to reduce the risk of stroke and blood clots in patients diagnosed non-valvular atrial fibrillation (AF), a type of abnormal heart rhythm.

Since being approved by the FDA in 2010, more than 6.2 million prescriptions for Pradaxa have been dispensed; however, its manufacturer, Boehringer Ingelheim, has received hundreds of reports of serious bleeding events, several of which have resulted in death.

In their study, the FDA was able to determine that, while associated with a lower risk of clot-related stroke, Pradaxa does carry a significantly increased risk of gastrointestinal (GI) bleeding than warfarin and a similar risk of myocardial infarction.

The FDA stated that it will continue investigating bleeding events linked to Pradaxa in an attempt to determine the cause of the increased bleeding risks.

Other Pradaxa Side Effects

The following adverse events have also been reported to the FDA in patients taking Pradaxa:

Cerebrovascular accident

  • Abdominal discomfort
  • Chest pain
  • Pulmonary embolsim
  • Hemoglobin decrease
  • Anemia
  • Renal failure
  • Cerebral hemorrhage
  • Cerebral Infarction
  • Death


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