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Martin Murray

Packaging Causes Product Recall

By November 8, 2012

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Product Recall Defective packaging has been cited as the reason why Boehringer Ingelheim has been forced to recall some of its 75-milligram Pradaxa capsules. The anti-clotting drug is packaged in a bottle and some have been found to allow moisture to enter, which could affect the drug.

Not a great week for Pradaxa, as the FDA has been investigating a large number of post-marketing reports of gastrointestinal bleeding in patients who were treated with the anti-clotting drug. Two years after FDA approval the drug has been linked to more than 500 deaths and more side effect reports than any other drug, according to the Institute for Safe Medication Practices (ISMP). However the FDA have given the all clear despite claims from some that the FDA's own methodology is flawed, including the Observational Medical Outcomes Partnership (OMOP), which is a non-profit group in part formed by the FDA.

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