Pradaxa maker, Boehringer Ingelheim GmbH, has confirmed 260 deaths, to date, in relation to the anti-clotting medication. It was just earlier this month that the Company confirmed that roughly 50 Pradaxa patients worldwide had died due to bleeding following treatment with the drug.
Boehringer Ingelheim confirmed the 260 fatalties after the German outlet, Spiegel Online just reported, that the European Medicines Agency (EMA) was advised of 256 global deaths associated with Pradaxa. Of those, 21 were reported in Europe, BusinessWeek said.
In the U.S., Pradaxa is approved to prevent strokes in patients diagnosed with atrial fibrillation, is among several new anti-blood-clotting drugs that aim to replace warfarin. Unlike warfarin, Pradaxa is not associated with some dangerous food interactions. However, excessive bleeding – a danger posed by all bloodthinners – can be treated with vitamin K in warfarin patients. With Pradaxa, however, there is no antidote for this side effects.
Boehringer “takes all reports about side effects and deaths very seriously and continuously monitors the use of all its medication including Pradaxa,” said Klaus Dugi, senior vice president for medicine and Boehringer, on the firm’s website, Bloomberg Businessweek reported.
U.S. Pradaxa approval occurred last year; Boehringer received European approval this year for patients with atrial fibrillation.
Pradaxa is excreted through the kidneys. Because of this, impaired kidney function could result in significantly increased levels of Pradaxa in the body, which can lead to an excessive bleeding risk.
Regulators in some countries have recently expressed concern about Pradaxa’s potential side effects. For instance, in late October, Boehringer Ingelheim agreed to advise European doctors that elderly patients, those older than 75, as well as patients with renal impairment, should undergo annual kidney checks.
Of the 50 initial bleeding death reports previously reported worldwide, 14 were reported in Japan and occurred because patients could not fully sufficiently excrete Pradaxa. Japanese regulators told Boehringer Ingelheim that they must issue a warning for Prazaxa—the Japanese brand for Pradaxa—concerning possibly fatal bleeding after 82 of about 64,000 mainly senior patients suffered serious bleeding, said NewsInferno. In New Zealand, 122 cases Pradaxa side effects were reported to the Centre for Adverse Reactions Monitoring (CARM); two of five involved bleeding.