Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Drug Safety Update - July 2012

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for July 2012 (PDF).

This issue reminds clinicians of the risk of serious haemorrhage observed with dabigatran (Pradaxa®) and clarifies the contraindications and monitoring requirements.

  • Dabigatran is contraindicated in clinical conditions associated with a significant risk of bleeding, such as:
    • 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
  • The benefits and risks of starting dabigatran should also be considered carefully for patients who may have other conditions that put them at an increased risk of major bleeding (but in whom treatment with dabigatran is not contraindicated)
  • Use of dabigatran is contraindicated with dronedarone, and with other anticoagulants, except when switching treatment to or from dabigatran, or with the use of unfractionated heparin for maintenance of venous or arterial catheter patency
  • Concomitant use of antiplatelet agents increases the risk of major bleeding with dabigatran approximately two-fold, therefore a careful benefit-risk assessment should be made prior to initiation of treatment

Renal function should be assessed in all patients before starting dabigatran and at least once a year in patients older than 75 years or those with a suspected decline in renal function. Dabigatran is contraindicated in patients with severe renal impairment (creatinine clearance <30 mL/min)

Action: Clinicians will find this publication to be a useful review of current issues in drug safety.

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