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FDA issues warning on dabigatran handling, storage
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The potential for dabigatran to breakdown as a result of moisture and loss of potency has prompted the FDA to issue a public alert that capsules of the drug should be dispensed and stored only in the original bottle or blister package.
According to the FDA’s recommendation, dabigatran (Pradaxa, Boehringer Ingelheim) should only be dispensed in the original manufacturer packaging and should not be repackaged in standard amber pharmacy vials. The warning was also extended to patients, stating that dabigatran capsules should not be kept in any other container, such as pill boxes or organizers, and that only one bottle should be opened at a time.
Currently, the drug’s label addresses handling and storage requirements, but the FDA said these requirements were not commonly known or followed by users and pharmacies.
Although the labeling also states that the capsules should be discarded 30 days after opening, the FDA is currently reviewing data that indicate the product maintains potency up to 60 days after opening, provided it is stored in the original bottle and the handling requirements are met. According to the release, once the FDA’s review of this material is complete, any changes will be added to the product label.
To read more Cardiology Today coverage of dabigatran, click here.
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