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  • FDA Date: 03/29/2011

    Pradaxa (dabigatran etexilate mesylate) FDA Drug Safety Communication

    Special Storage and Handling Requirements must be Followed for Pradaxa (dabigatran etexilate mesylate) Capsules

    This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

    The FDA is alerting the public to important storage and handling requirements for Pradaxa (dabigatran etexilate mesylate) capsules. Due to the potential for product breakdown from moisture and loss of potency, Pradaxa capsules should only be dispensed and stored in the original bottle or blister package and patients should be aware of the specific handling requirements.

    The Pradaxa label and Medication Guide contain information about these special storage and handling requirements, but FDA is concerned that these requirements are not commonly known and are not being followed by Pradaxa users and by pharmacies.

    We are aware that many consumers use pill boxes or pill organizers to aid in remembering to take their medications. However, because of the potential for product breakdown and loss of potency, consumers should not store Pradaxa in any container other than the original manufacturer packaging. Additionally, pharmacists should only dispense Pradaxa capsules in the original manufacturer packaging. Using the manufacturer packaging will minimize product breakdown from moisture. Pradaxa is packaged in a bottle containing a 30-day supply with a desiccant (drying agent) in the cap to help keep moisture away from the capsules. Pradaxa capsules are also available in a blister package which protects from moisture.

    Although the current Pradaxa label states that the product should be discarded 30 days after the original bottle is opened, data currently under review by the FDA indicate that the product maintains its potency up to 60 days after bottle opening as long as it is stored in the original bottle and the handling requirements are met--including that the cap is closed tightly after each use, and the bottle is kept away from excessive moisture, heat, and cold. The manufacturer is gathering more information on whether the product can be used after 60 days and this information will be added to the Pradaxa label when FDA's review is complete.

    View the full FDA Drug Safety Communication on FDA.gov