FDA Advises Pharmacists & Patients to Follow Pradaxa Storage and Handling Instructions

April 7, 2011 9:59 AM

Food and Drug Administration (FDA) has issued a safety alert regarding special handling instructions for Pradaxa^® due to concerns that the handling requirements are not commonly known. FDA advises that Pradaxa, an anticoagulant medication known as a direct thrombin inhibitor, should only be dispensed and stored in the original bottle or blister package due to the potential for product breakdown from moisture and loss of potency.

Specifically, FDA advises pharmacists that Pradaxa should only be dispensed in the original manufacturer bottle with the original dessicant cap. Pradaxa should not be repackaged. Patients are advised to store the medication in the original container and avoid using pill boxes or other containers for storage. Also, once a bottle is opened, the product must be used within 30 days to ensure potency. The Pradaxa label and medication guide contain more information about these storage and handling requirements.