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Sunday, November 27, 2011

EMA To Require Renal Function Testing For Patients Taking Pradaxa.

In continuing coverage, MedPage Today Share to FacebookShare to Twitter (10/29, Gever) reported that Boehringer Ingelheim, "the manufacturer of dabigatran etexilate (Pradaxa), will tell European prescribers that renal function testing is a must when starting patients on the drug." The company "agreed that renal function testing was necessary under an agreement with" the European Medicines Agency (EMA). In a press release, the German drugmaker noted, "The communication to be sent to healthcare professionals strengthens that patients taking Pradaxa should have their renal function evaluated prior to treatment initiation." MedPage Today explained, "Because dabigatran is cleared renally, impaired kidney function could lead to abnormally high levels of the drug in circulation, leading to excessive risk of bleeding."

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