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Europe Regulator Addresses Pradaxa Bleeding Deaths

Nov 18, 2011 | Parker Waichman LLP

However, the European Medicines Agency (EMA) said that new prescribing recommendations issued last week would mitigate the Pradaxa bleeding risk.

Those recommendations advised doctors to subject Pradaxa patients older than 75, as well as those with renal impairment, to annual kidney checks. Pradaxa is excreted through the kidneys, thus impaired kidney function could lead to abnormally high levels of the drug in circulation, leading to excessive risk of bleeding.

Boehringer Ingelheim has confirmed 260 reports of fatal bleeding, including 21 in Europe, among Pradaxa patients worldwide, up from the 50 deaths the company confirmed at the start of November. Like all blood thinners,  it carries a risk of bleeding.    In its statement, the EMA maintained that the number of Pradaxa bleeding reports "has to be seen in the context of the rapidly increasing use of Pradaxa worldwide."

In the past several months, regulators in various countries have pushed Boehringer Ingelheim to increase warnings on Pradaxa recently.  In August, for example regulators in Japan told Boehringer Ingelheim to issue a warning for Pradaxa and potentially fatal bleeding after 81 patients taking it there suffered heavy bleeding.

According to a report issued by the Institute for Safe Medication Practices (ISMP), since its October 2010 approval, Pradaxa has been named in more U.S. Food & Drug Administration (FDA) Adverse Event Reports than more than 98% of the medications the group monitors.

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