Pradaxa Bleeding Deaths Jump Five Times Since Last Report

The maker of <"">Pradaxa says 260 deaths worldwide have been linked to the blood thinner. According to report from Reuters, Boehringer Ingelheim has confirmed that all of the reported Pradaxa deaths were the result of fatal bleeding.

The latest figure is five times higher than what Boehringer Ingelheim reported earlier this month, when the company said it had tallied 50 deaths from serious bleeding worldwide among patients taking Pradaxa.

In the U.S., Pradaxa was approved last October to prevent strokes in people with atrial fibrillation, and 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.

Despite the jump in the number of bleeding deaths among Pradaxa patients in such a short period, Boehringer Ingelheim maintains the drug is still a safer alternative to warfarin. In a statement, the company said data from its RE-LY study, which was used for the drug’s approval, indicated the risk of deadly bleeding linked to warfarin was more than 40 percent higher than that associated with Pradaxa.

Boehringer Ingelheim’s assurances not withstanding, concerns surrounding Pradaxa have continued to grow. Earlier this month, the drug maker agreed to notify European doctors that patients older than 75 and those with renal impairment should undergo kidney checks every year. 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.

In October, the Institute for Safe Medication Practices (ISMP) reported that since its U.S. approval last year, Pradaxa has been named in more U.S. Food & Drug Administration (FDA) adverse event reports than over 98% of the medications the group monitors. Pradaxa side effect reports outpaced most other drugs, including warfarin, with the majority involving serious bleeding or blood clots in the elderly, the ISMP said.

Such safety concerns have some doctors approaching Pradaxa and other new blood thinners with caution.

“I’m more confused than informed,” Dr Sanjay Kaul, a prominent heart doctor at Cedars-Sinai in Los Angeles, said after hearing presentations on the medicines at the American Heart Association, which is being held this week in Orlando, Florida.

“The anti-thrombotic landscape has become more fuzzy for me, and it will continue to be fuzzy for the next few years until we make some sense out of the data.”

This entry was posted in Pharmaceuticals, Pradaxa. Bookmark the permalink.

© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.