Pradaxa Linked to 50 Bleeding Deaths since Approval, Drug Maker Says

The maker of Pradaxa has confirmed that roughly 50 patients worldwide died due to bleeding following treatment with the new anti-clotting medication. According to a report from Reuters, Boehringer Ingelheim maintains that the number of deaths fell within expectations from the clinical study that led to <"">Pradaxa‘s market approval.

In the U.S., Pradaxa is approved to prevent strokes in people with atrial fibrillation. According to Reuters, it is one of a number of new anti-blood-clotting pills expected to replace warfarin. Unlike warfarin, Pradaxa is not associated with dangerous interactions with some foods. However, excessive bleeding from warfarin can be treated with vitamin K, while there is no antidote for this side effect when it occurs in Pradaxa patients.

Recently, regulators in some countries have become more concerned about possible Pradaxa side effects. Last week, for example, Boehringer Ingelheim agreed to notify European doctors that patients older than 75 and those with renal impairment should undergo kidney checks every year. Pradaxa is excreted through the kidneys, thus impaired kidney function could lead to abnormally high levels of the drug in circulation, leading to excessive risk of bleeding.

In August, regulators in Japan – where the drug is sold as Prazaxa – told Boehringer Ingelheim to issue a warning for Pradaxa and potentially fatal bleeding after 81 of the almost 64,000 mainly elderly patients taking it there suffered heavy bleeding. In New Zealand, 122 cases of side effects in Pradaxa patients have been reported to the Centre for Adverse Reactions Monitoring (CARM), of which two out of five involved bleeding.

According to the latest Reuters report, around 50 bleeding deaths have been reported in patients worldwide since Pradaxa was approved last year. According to a report from Bloomberg News, some of those deaths occurred in Germany, while 14 were reported in Japan since August. In Japan, the deaths occurred because patients couldn’t sufficiently excrete the blood-thinner.

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