Boehringer agrees Pradaxa kidney function warning
pharmafile | October 30, 2011 | News story | Sales and Marketing |Â Â AF, EMA, Pradaxa, renal functionÂ
Boehringer Ingelheim is to alert doctors in Europe of the need to check patients’ kidney function before prescribing anticoagulant Pradaxa.
The action has been agreed with the European Medicines Agency to draw attention to potential renal problems related to its use.
Direct thrombin inhibitor Pradaxa (dabigatran etexilate) is approved in Europe for the prevention of stroke and systemic embolism in adults with non-valvular atrial fibrillation (AF) with one or more risk factors.
It also approved for the prevention of venous thromboembolic events (VTE) in adults who have had elective total hip or total knee replacement surgery.
Its contraindications already include hepatic impairment or liver disease expected to have any impact on survival – patients with elevated liver enzymes were excluded in clinical trials investigating blood clot prevention.
Since Pradaxa is mainly excreted renally, the treatment should not be prescribed to patients with severe renal impairment (creatinine clearance less than 30 ml/min).
Anticoagulants can increase bleeding, a risk factor that increases with age or when a patient has multiple risk factors, including renal impairment.
The manufacturer will also strengthen warnings in its summary of product characteristics and prescriber guides, and urged doctors to report any adverse events to Boehringer or to their national health authority.
In a statement, Boehringer said: “It is of critical importance that healthcare professionals abide by the information regarding the appropriate and safe use of Pradaxa as provided in the label.”
While on treatment with Pradaxa, renal function should be assessed where a decline in renal function is suspected, such as hypovolemia and dehydration.
In patients older than 75 or in patients with renal impairment, the renal functions should be assessed at least every year.
Despite the new communication to doctors, Pradaxa appears well thought of by regulators: NICE has just recommended it for prevention of stroke and clots in AF patients after initially rejecting the drug on cost-effectiveness issues.
Approved in Europe in 2008, the once-daily pill is pitted against warfarin, Sanofi-Aventis’ once-daily injection Clexane and Bayer’s novel treatment Xarelto in VTE.
Adam Hill
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