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Pradaxa Maker Says Patients Need Kidney Checks

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The maker of Pradaxa, Boehringer Ingelheim, just announced that in Europe, patients need kidney checks before taking the anti-clotting medication. The announcement is not doing much for Pradaxa’s safety profile.

According to Reuters, Pradaxa, a thrombin inhibitor, is the first of a new class of anti-clotting medications on which high hopes were placed. Unlisted Boehringer, the second-largest drugmaker in Germany, agreed with the European Medicines Agency’s (EMA) that updated information be provided to European healthcare professionals, Reuters noted.

The information states that Pradaxa patients should have their kidneys checked before treatment and patients over the age of 75 or renally impaired patients should also have their kidneys checked at least once yearly during Pradaxa treatment, Reuters explained. Kidney checks are also urged for other conditions, such as when patients suffer from dehydration during treatment.

Pradaxa received European clearance for stroke prevention this August and was introduced to replace the older, potentially dangerous, warfarin, said Reuters. Kidneys will gradually filter the active ingredient in Pradaxa out of the blood stream; however, a kidney malfunction could cause an overdose and an increased internal
bleeding risk, noted Reuters.

The physician update was prompted by reports of severe bleeding following the
European market launch, said a spokesman for Boehringer. Previously, physicians had
been advised that Pradaxa should not be prescribed to patients suffering from severe kidney malfunctions, said Reuters, which noted that Japanese regulators advised the drug maker, when Pradaxa was released, that strong warnings should be provided to doctors concerning the increased risk for potentially fatal bleeding.

There is no antidote to reverse bleeding should a Pradaxa

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overdose occur, noted the New England Journal of Medicine said Reuters. Bleeding side effects from warfarin can be stopped by the administration of vitamin K.

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