March 30th, 2011
FDA Warns Against Repackaging Dabigatran
The FDA has issued a safety communication regarding dabigatran (Pradaxa). Because the drug is subject to product breakdown and loss of potency due to moisture, the FDA recommends that it should be dispensed and stored in its original packaging and that consumers avoid using pill boxes or pill organizers with it.
Pradaxa is supplied as either a bottle with a 30-day supply of the drug and a desiccant in the cap or in a blister package. The current label states that the drug should be discarded 30 days after the bottle has been opened, but the FDA now says that the drug maintains its potency for up to 60 days as long as it is stored in the original bottle and the cap is closed tightly. The bottle should be kept away from excessive moisture, heat, and cold, according to the FDA. The agency advises that only one bottle of Pradaxa should be open at a time.
Here is the FDA’ advice for healthcare professionals:
- Tell patients it is important to follow the special storage and handling requirements for Pradaxa.
- Tell patients that Pradaxa must be kept in the original bottle or blister package to protect from moisture. The bottle contains a dessicant in the cap, and the blister package protects unopened pills from moisture.
- Tell patients that Pradaxa capsules must not be stored in pill boxes or pill organizers.
- Pharmacists should only dispense Pradaxa in the original manufacturer bottle with the original dessicant cap. Do not repackage Pradaxa capsules in standard amber pharmacy vials.
- Pharmacists should not open the Pradaxa bottle when dispensing. When more than one bottle is dispensed, tell the patient to only open one bottle at a time.
- Pharmacists should place an auxiliary expiration label on the bottle and instruct the patients to date the bottle to expire 60 days after opening.
- Pharmacists can also number the bottles (e.g., bottle #1 and bottle #2) when dispensing multiple bottles so the patient can keep track of which bottle they opened.
- Report adverse events involving Pradaxa to the FDA MedWatch program.
For more of our coverage on dabigatran, check out the Dabigatran Resource Round-Up.