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Mixed Results on Pradaxa from FDA — Physician’s First Watch

Medical News |
May 14, 2014

Mixed Results on Pradaxa from FDA

By Larry Husten

In the latest development in its ongoing review of the new oral anticoagulant dabigatran (Pradaxa), the FDA on Tuesday offered somewhat reassuring news about the sometimes controversial drug.

The agency's study of over 134,000 Medicare patients found that dabigatran was associated with a reduced risk for ischemic stroke, bleeding in the brain, and death, compared with warfarin. But the study also found an increased risk for major gastrointestinal bleeding with dabigatran. There was no difference between the drugs in myocardial infarction risk.

The findings were mostly consistent with earlier results from the pivotal RE-LY study, although an increased risk for MI found in the earlier study was not found in the new FDA analysis.

The agency said it has not made any changes to the label for dabigatran and that it continues to believe that the drug has "a favorable benefit to risk profile." It will continue to investigate the risk for GI bleeding seen with dabigatran.

Adapted from CardioExchange

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