After evaluating international reports of bleeding, the Therapeutic Goods Administration published a Safety Advisory on 3 November 2011 regarding the risk of bleeding in people using dabigatran (Pradaxa).1 This advisory summarises new recommendations now in place for assessing kidney function before starting this medicine and during its use.

The TGA advises that kidney function should be assessed:

  • for all patients before starting dabigatran therapy
  • during treatment when a decline in kidney function is suspected, for example, low blood volume, dehydration and when certain medicines which may affect kidney function are taken at the same time
  • at least once a year in elderly patients (> 75 years) or in patients with moderate kidney impairment (creatinine clearance < 50 mL/min).

Patients with severe kidney impairment (creatinine clearance < 30 mL/min) should not take dabigatran.



Note that in the August 2011 NPS RADAR article 'Dabigatran (Pradaxa) for stroke prevention in patients with non-valvular atrial fibrillation', a typographical error appeared in the margin note on page 6 relating to the age range criteria of who is at risk: '≤ 75' should have read '≥ 75'.