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Pradaxa Maker Confirms Deaths from Bleeding

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Anti-stroke medication, Pradaxa, has been linked to deaths according to Pradaxa manufacturer Boehringer Ingelheim GmbH. Boehringer Ingelheim GmbH confirmed that the deaths occurred in German patients taking Pradaxa, said Die Zeit, citing Boehringer spokesman, Reinhard Malin.

The blood thinner, Pradaxa is approved to prevent strokes in people with atrial fibrillation and is one of a number of new anti-blood-clotting pills expected to replace the older generation warfarin. Pradaxa is excreted through the kidneys, so impaired kidney function can cause unusually high levels of the drug to remain in the body, which can lead to very significant bleeding risks.

According to Bloomberg News, on October 27 Boehringer warned European physicians to be sure to conduct regular kidney testing in patients over the age of 75 as well as for patients with known kidney medications, citing Die Zeit.

Boehringer said it is investigating individual cases, but would not go as far to say how many deaths have been associated with Pradaxa, said Bloomberg News, Die

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Zeit said the figure of 50 deaths world-wide is “probably in the right range,” according to Malin, who also confirmed that, as of this August, 14 Japanese patients died of internal bleeding because their bodies were unable to adequately excrete Pradaxa.

“While on treatment, renal function should be assessed in clinical situations where a decline in renal function is suspected (e.g. hypovolemia, dehydration, and with certain co-medications),” the EMA said. “In patients older than 75 or with renal impairment, renal function should be assessed at least yearly whilst on treatment. Given Pradaxa is mainly excreted renally, the treatment should not be prescribed to patients with severe renal impairment (creatinine clearance less than 30 ml/min),” the EMA continued.

In Japan—the drug is sold as Prazaxa there—Boehringer was told in August to issue a warning regarding potentially fatal bleeding after 81, mostly elderly, patients suffered heavy bleeding.

The Institute for Safe Medication Practices (ISMP) has reported that since Pradaxa was approved in the United States last October, it has been named in more U.S. Food & Drug Administration (FDA) adverse event reports than over 98% of the FDA-monitored medications, said NewsInferno. As a matter-of-fact, the ISMP stated that, within just 12 weeks of its approval, Pradaxa was the suspect drug in 307 serious adverse events reported to the FDA, outpacing even the drug it was meant to replace: warfarin.

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