FDA Emphasizes Special Storage and Handling Requirements for Pradaxa

The FDA is alerting healthcare providers and patients of important storage and handling requirements for Pradaxa (dabigatran etexilate mesylate capsules; Boehringer Ingelheim). Because of the potential for product breakdown from moisture and subsequent loss of potency, Pradaxa should only be dispensed and stored in the original bottle or blister package. Once the bottle is opened, the product must be used within 60 days. The Pradaxa labeling and Medication Guide contain information about these special storage and handling requirements, but the FDA is concerned that these requirements are not commonly known and are not being followed by Pradaxa users and by pharmacies.

Pradaxa is indicated to reduce risk of stroke and systemic embolism in non-valvular atrial fibrillation.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm249005.htm.