FDA: Store Pradaxa Only in Original Containers

The anticoagulant is vulnerable to breakdown, loss of potency otherwise

WEDNESDAY, March 30 (HealthDay News) -- The anticoagulant dabigatran etexilate mesylate (Pradaxa), a direct thrombin inhibitor, should be dispensed and stored only in its original bottle or blister package because exposure to moisture may cause product breakdown and loss of potency, according to an alert issued by the U.S. Food and Drug Administration.

The agency advises pharmacists to dispense the drug only in its original manufacturer bottle with the original dessicant cap rather than repackaging it in standard amber pharmacy vials. Patients, too, are advised to store the drug in its original container, rather than pill boxes or organizers, and should open only one bottle at a time.

The storage and handling recommendations are no different than those posted on the drug's label and medication guide, but the FDA is concerned that users of dabigatran etexilate mesylate and pharmacies are not thoroughly knowledgeable about the storage and handling requirements and may not be following them.

According to the FDA, "once the bottle is opened, the product must be used within 60 days. Read the Medication Guide for Pradaxa for more information about these special storage and handling requirements."

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