Pradaxa: safety update owing to risk of serious haemorrhage

The MHRA has issued updated safety advice for the anticoagulant dabigatran (Pradaxa).

Concomitant use of antiplatelet agents with dabigatran increases the risk of major bleeding approximately three-fold | SCIENCE PHOTO LIBRARY

Use of dabigatran with dronedarone or alongside other anticoagulants is contraindicated. The only exceptions to this advice are when switching anticoagulant therapy to or from dabigatran, or using unfractionated heparin for maintenance of catheter patency.

Further contraindications

The agency reminds healthcare professionals that dabigatran is also contraindicated in clinical conditions where the patient is at significant risk of major bleeding. These include:

  • current or recent gastrointestinal ulceration;
  • malignant neoplasms;
  • recent brain or spinal injury;
  • recent brain, spinal or ophthalmic surgery;
  • recent intracranial haemorrhage;
  • oesophageal varices;
  • arteriovenous malformations;
  • vascular aneurysms;
  • major intraspinal or intracerebral vascular abnormalities.

Clinicians should carefully assess the benefits and risks of starting dabigatran in patients who may have other conditions that increase the risk of bleeding.

Assess for kidney dysfunction

Renal function should be assessed in all patients before starting dabigatran.

View Pradaxa drug record

Further information: Boehringer Ingelheim Ltd

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