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Pradaxa Requires Caution, European Regulators Warn

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A rising number of Pradaxa bleeding cases have prompted European regulators to warn that Pradaxa prescriptions should be written with caution. The new stroke prevention pill has been linked to 256 cases of deadly bleeding.

The maker of Pradaxa, Boehringer Ingelheim recently confirmed that about 260
Pradaxa deaths, worldwide, were linked to the blood thinner. The current figure is about five times greater than what Boehringer Ingelheim initially reported this month when it said 50 fatal deaths from Pradaxa bleeding had been totaled.
Pradaxa safety concerns have been on the rise following the deaths, said Reuters.

“The agency will continue to closely monitor this issue and the overall safety profile of Pradaxa,” said the European Medicines Agency (EMA),

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in a statement after its monthly drug expert committee meeting, said Reuters.

Last October in the U.S., Pradaxa was approved to prevent strokes in atrial fibrillation patients, and is one of some new anti-blood-clotting pills meant to replace warfarin. Unlike warfarin, Pradaxa is not associated with dangerous food interactions.
But, while warfarin interactions are treatable with vitamin K, there is no antidote for this side effect in Pradaxa patients,

All anti-blood-clotting medications carry some internal bleeding risks.

The EMA just said that Pradaxa efficacy as seen in clinical trials remains the same, but usage changes should be implemented to “adequately manage the risk of bleeding,” wrote Reuters. The EMA repeated that Pradaxa should be used with caution and should be prescribed at lower doses in patients over the age of 75 and in patients diagnosed with moderate kidney impairment; Pradaxa is not recommended for patients with severe kidney problems, the EMA stressed, said Reuters.

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