Pradaxa linked to 117 deaths during Q2 2001

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A new report believes the new blood-thinner drug Pradaxa was likely responsible for at least 117 deaths in the second quarter of last year, alone.

According to a report from the Institute for Safe Medication Practices, the alternative treatment to the ages old drug warfarin in the prevention of blood clots that could lead to heart attacks, stroke, or sudden death.

During its short time on the market, Pradaxa has been linked to severe bleeding episodes among the people taking the drug. The Food and Drug Administration had received reports on at least six deaths among patients taking the drug. From just April through June last year, the agency received reports on a massive rise in the death toll linked to the drug.

Overall, the FDA received more than 856 reports on serious injuries among people taking Pradaxa during that time, ISMP notes in its recently published quarterly report. This is the most among any drug tracked by the FDA. Of those reports, 511 included incidents of severe bleeding.

People taking Pradaxa, especially those over 80, are more likely to suffer severe bleeding episodes – namely cerebral hemorrhaging or gastrointestinal bleeding – than others, though the risk is considerably high for any patient taking the drug.

A main concern with Pradaxa is its lack of an antidote or an effective means of removing the drug from a person’s bloodstream to counter the severe bleeding side effects. People who suffer even minor falls or are bruised can suffer from this life-threatening side effect.