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.

3 Responses to “FDA Warns Against Repackaging Dabigatran”

  1. William DeMedio, MD says:

    Poor planned obselescence of the worst kind. At least warfarin keeps well. For the cost pradaxa should keep well. I wonder how well it will do in the real world now. Elders have difficulty with things like keeping bottles tightly closed and keeping track of which to open first.

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  2. As a pharamacist, I am often amazed at patient’s ability to “stock-pile” medication. I have seen patients present to the ER, clinic, or pharmacy with bottles dispensed several years ago, so I agree this is going to be a real-world problem.

    Given dabigatran’s price (any many seniors are paying out of pocket), do you think that we will be effective in convincing them to throw away any remaining stock in 60 days? These patient’s are often admitted to the hospital or temporarily placed in rehab facilities, but the clock remains ticking for the 60 day beyond-use-date.

    Originally, this came out with a 30 day beyond-use-date. I’m amazed that the FDA did not make the company perform extended stability testing prior to approval….why not see what the *longest* beyond-use-date possible is to begin with?

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