FDA will investigate Pradaxa bleeding deaths

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The Food and Drug Administration announced this week it is investigating reports of serious, sometimes fatal bleeding events among people taking the blood thinning drug Pradaxa.

Recently, numerous reports of serious and a few hundred fatal bleeding episodes have been reported among people taking the relatively new drug treatment for the prevention of blood clots. Bleeding has most often been reported in the gastrointestinal tract and near the brain.

The German manufacturer of Pradaxa recently admitted that more than 250 people have died as a result of Pradaxa-related bleeding.

In a statement this week, the FDA said it would review the post-market data it has received on the reported adverse reactions among those taking Pradaxa and compare whether the rates of these incidents is normal in relation to the number of adverse reactions reported during clinical trials used to get the drug approved.

The FDA could act to increase safety warnings on Pradaxa labels to call more attention and provide more details on the risk of serious bleeding reported among those taking the drug.
Pradaxa is approved to treat some forms of atrial fibrillation, the most common heartbeat abnormality.