Boehringer Ingelheim has recalled a lot of its blood thinner Pradaxa 75 mg because of potential problems with bottles that may have affected the drug's quality.
The company said in a release that the issue stemmed from "a potential packaging defect on this lot that may compromise the bottle integrity. A damaged bottle could allow moisture to get into the bottle." While the risk is small, the company said it is possible that as a result the pills might not deliver "a fully effective dose," which could put patients at increased risk of ischemic stroke. The company, however, recommends that patients continue to take whatever pills they have until they can get replacements.
The company packages the drug in blister packs for some markets but has said when it comes in bottles, the hydroscopic pellets in capsules make Pradaxa sensitive to humidity and an opened bottle should be used within 30 days. Boehringer said it thinks it has gotten its hands on most of the suspect bottles and that the recall is precautionary.
The recall came the same day that the company released the interim results of a new study showing that the drug performed nearly the same in patients followed for more than four years, showing that long-term use does not lead to any greater safety risks.
- here's the release