{"id":7269,"date":"2011-03-30T13:03:21","date_gmt":"2011-03-30T17:03:21","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?p=7269"},"modified":"2011-07-19T17:44:29","modified_gmt":"2011-07-19T21:44:29","slug":"fda-warns-against-repackaging-dabigatran","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2011\/03\/30\/fda-warns-against-repackaging-dabigatran\/","title":{"rendered":"FDA Warns Against Repackaging Dabigatran"},"content":{"rendered":"

The FDA has issued a safety communication<\/a> 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.<\/p>\n

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.<\/p>\n

Here is the FDA’ advice for healthcare professionals:<\/p>\n