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March 2012 Br J Cardiol 2012;19:11

MHRA issues advice on dabigatran

BJCardio Staff

Abstract

This topic was also included in the UK MHRA’s December Drug Safety Update, which gave the following new advice: Do not start dabigatran in any patient with severe renal impairment (creatinine clearance <30 mL/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 co-medications); at least annually in patients older than 75 years; and at least annually in patients with renal impairment. Check for signs of bleeding or anaemia and stop treatment if severe bleeding occurs. In the US, the Food and Drug Administrati

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