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Health Canada issues warning, safety label changes for Pradaxa

Filed March 23rd, 2012 Joshua Sophy

Canada’s health regulators have issued a warning on updated safety labels for the blood-thinning drug Pradaxa, noting the risk of severe bleeding events specifically for patients with reduced kidney function or those with certain types of heart valve disease or artificial heart valves.

According to a statement from Health Canada that’s a re-issue of a letter sent from the makers of Pradaxa to physicians and regulatory agencies around the world, new labels of the drug in the country (where it’s sold as Pradax). The relatively new drug has been linked to fatal or life-threatening bleeding episodes among people taking the drug, including incidents of brain hemorrhage and severe gastrointestinal bleeding. 

These risks are heightened among patients with several pre-existing conditions, including reduced kidney function. In new warnings added to the drug in Canada, the agency warns that a prescribing physician may closely monitor a prospective patient’s kidney function and that people with severely reduced or no kidney function will not get Pradaxa.

Further, patients 75 years or older who have normal kidney function at the time they start Pradaxa should be monitored at least annually to ensure their kidneys still function normally. All patients on Pradaxa should be aware of any signs of reduced kidney function and report them to their physicians.

The drug, according to the updated safety labels, is also not recommended for patients with either an artificial heart valve system or those suffering from severe heart valve disease.

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