EMA Says Pradaxa Label Should be Updated to Reflect Bleeding Risks


EMA Says Pradaxa Label Should be Updated to Reflect Bleeding RisksOverview: The European Medicine Agency (EMA) is recommending that the Pradaxa (dabigatran) safety label be updated to reflect the risk of bleeding. The blockbuster blood-thinning drug has also raised safety concerns over the risk of irreversible bleeding, meaning minor accidents could turn deadly.




  • EMA wants clearer information on Pradaxa’s safety label regarding bleeding risks
  • There is no antidote to stop the bleeding in Pradaxa patients, making even minor falls dangerous
  • In January, the ISMP report 500 cases of bleeding linked to Pradaxa, some cases were fatal

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

EMA Recommendations

The EMA stated today that the label should be modified to address the risk of bleeding and include more comprehensive information about how to handle bleeding complications if they occur. The agency noted that “the frequency of occurrence of fatal bleedings with Pradaxa seen in post-marketing data was significantly lower than what was observed in the clinical trials” but the issue should still be closely monitored.

Pradaxa Bleeding Risks

Last November, the EMA database reported over 250 bleeding-induced deaths linked to Pradaxa. The report raised concerns both within and outside of Europe, and a month later the U.S. Food and Drug Administration (FDA) launched a safety review of the drug. At the time, the EMA emphasized the medications’ contraindications, particularly in those with renal impairment and lower doses in the elderly. In January, the Institute for Safe Medication Practices (ISMP) reported over 500 Pradaxa-linked hemorrhaging events, including some fatalities.

Due to lack of a reversal agent, bleeding in Pradaxa patients is irreversible and therefore potentially fatal. The fact that there is no antidote for the bleeding means that even minor incidents can become deadly. This risk was emphasized in March, when the Journal of Neurosurgery published a case study of a Pradaxa patient who died of a cerebral hemorrhage after a ground-level fall in his home.

Recently, the Houston Press published an article about a woman who took Pradaxa and died after a fall in her kitchen. Her family feels that they were not properly warned about the irreversible bleeding complications, and assert that she would still be alive if she had been taking warfarin, which can be reversed with vitamin K.


The EMA approved Pradaxa in 2008 to prevent venous thromboembolism (VTE) in patients who had total hip replacement surgery or total knee replacement surgery. In 2011, the drug was approved to prevent stroke in non-valvular atrial fibrillation patients with at least one risk factor.

The U.S. Food and Drug Administration (FDA) approved Pradaxa in 2010 to prevent blood clots and stroke in patients with atrial fibrillation.

Pradaxa was originally hailed as a superior alternative to warfarin (sold under the brand name Coumadin), which has a long list of interactions and requires regular blood testing. But the inability to stop its anticoagulant properties in the event of a serious bleed remains a concern.