Special Storage and Handling Requirements for Dabigatran

May 16, 2011

This podcast reviews key information about the safe storage, handling, and dispensing of Pradaxa (dabigatran etexilate mesylate) capsules.

This podcast reviews key information about the safe storage, handling, and dispensing of Pradaxa (dabigatran etexilate mesylate) capsules.

In late March, the FDA issued a Drug Safety Communication alerting health care professionals and the public to important storage and handling requirements for Pradaxa (dabigatran etexilate mesylate) capsules.

The FDA warned that, 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.” This means that patients are strongly advised against the use of pill boxes or pill organizers with Pradaxa.

Patients and health care professionals were also notified that “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.”

This podcast reviews key information about the safe storage, handling, and dispensing of Pradaxa (dabigatran etexilate mesylate) capsules and provides additional important safety recommendations for physicians and other health care professionals who prescribe and/or dispense this medication.

A complete transcript is available here.

Click here to download this podcast.