The December 2011 issue of Drug Safety Update from the MHRA includes an article advising healthcare professionals of the need to assess renal function in all patients prior to starting dabigatran, and at least once a year during continued treatment in those aged >75 years or those with a suspected decline in renal function. 

This article has been issued following a number of reported cases of serious and fatal haemorrhage in elderly patients with renal impairment who were receiving dabigatran.  Dabigatran is contraindicated in patients with a creatinine clearance <30mL/min to minimise the risk of bleeding, and those with moderate renal impairment (creatinine clearance 30–50mL/min) should be closely monitored, and a dose reduction considered (similar precautions are recommended for patients older than 75 years).      

The article (available at the link below) discusses the case reports and the new advice for healthcare professionals, as follows:

• Do not start dabigatran in any patient with severe renal impairment (creatinine clearance <30mL/min)

• Assess renal function:

- in all patients before starting dabigatran

- when a decline in renal function is suspected during treatment (e.g. hypovolaemia, dehydration, or with some comedications)

- at least annually in patients older than 75 years

- at least annually in patients with renal impairment

• Check for signs of bleeding or anaemia and stop treatment if severe bleeding occurs

The article goes on to discuss the need for close monitoring of all patients receiving any anticoagulant who are considered to be at an increased risk of bleeding. Recommendations regarding warfarin and rivaroxaban are briefly discussed.