- Prescribing Advice for GPs - https://www.prescriber.org.uk -

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.

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.