FDA Issues Alert About Dabigatran (Pradaxa) Storage and Handling Requirements
The U.S. Food and Drug Administration (FDA) has issued an alert regarding the proper storage and handling requirements for dabigatran etexilate mesylate (Pradaxa) 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.
Pradaxa was approved by the FDA for the treatment of for the prevention of stroke and blood clots in patients with atrial fibrillation in October 2010. The Pradaxa label and Medication Guide contains information about these special storage and handling requirements, but the FDA is concerned that they are not commonly known by the public. In response, they have issued the following recommendations:
- 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.
- Patients should not store or place Pradaxa capsules in any other container, such as pill boxes or pill organizers. The approved Pradaxa label states that once opened, the product must be used within 30 days. Patients are urged to open only one bottle of Pradaxa at a time.
- Health care professionals and patients should report adverse events or side effects related to the use of Pradaxa to the FDA's Medwatch Safety Information and Adverse Event Reporting Program by completing and submitting the report:
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- online at www.fda.gov/MedWatch/report.htm
- downloading a copy of the Voluntary Form FDA 3500 and returning as instructed
- telephone 1 (800) 332-1088 to request a reporting form, then sending the completed form to the address on the pre-addressed form
- submitting by fax to 1 (800) FDA-0178
Note: The FDA is currently reviewing data that indicate no significant loss of potency up to 60 days after the bottle is opened as long as Pradaxa is stored in the original bottle and the handling requirements are met.
Additional information is available on the FDA's website.
