FDA Says Bottled Dabigatran Good for 60 Days

Shelley Wood

March 30, 2011

March 30, 2011 (Rockville, Maryland) — Almost two months after heartwire first reported on the 30-day expiry date with dabigatran (Pradaxa, Boehringer Ingelheim)--and that even an investigator for the pivotal RE-LY trial was unaware of this issue--the FDA's MedWatch has issued a public alert about the drug's stability, explaining what it calls "special storage and handling requirements" [1].

"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," the MedWatch alert notes.

heartwire 's original story cited a 30-day expiry date for dabigatran capsules dispensed in a bottle (ie, 60 pills--a one-month supply), and packaging information for Pradaxa currently advises patients to discard the drug after the bottle has been opened for 30 days. The FDA alert, however, reminds patients to open only one bottle of a time and cites a 60-day expiry date. The difference is explained on the FDA's MedWatch website:

"Although 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."

That advice is important, experts told heartwire back in February, because it's not uncommon for patients to have more than one bottle of their medication on the go at the same time--one at work and one at home, for example. Many people also like to transfer their medications into dispensers to remind them whether they've taken their drug that day. A Boehringer Ingelheim spokesperson suggested that, to avoid any confusion, patients might want "take a marker and write the date on when you opened the bottle; this is the preferred option for the patient."

The American Pharmacists Association website, pharmacist.com, published a brief note about the 30-day stability issue on February 1, prompting heartwire 's story. Almost two weeks later, the American Heart Association issued a news release about the need to discard the drug after 30 days. The FDA now says "the manufacturer is gathering more information on whether the product can be used after 60 days, and this information will be added to the Pradaxa label when FDA's review is complete."


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