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Pradaxa Bleeding Reports Prompt FDA Review

Dec 8, 2011 | Parker Waichman LLP

Reports of serious and sometimes fatal bleeding among Pradaxa patients have prompted the U.S. Food & Drug Administration (FDA) to open a safety review of the blood thinner.   In a Drug Safety Communication issued yesterday, the FDA said it evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa, but did not indicate how many such reports it had received. 

In the past several months, regulators in various countries have pushed Boehringer Ingelheim to increase warnings on Pradaxa recently.  In August, for example regulators in Japan told Boehringer Ingelheim to issue a warning for Pradaxa and potentially fatal bleeding after 81 patients taking it there suffered heavy bleeding.  

Just last month, European regulators advised doctors to subject Pradaxa patients older than 75, as well as those with renal impairment, to annual kidney checks in order to mitigate any bleeding risks. 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.

Also last month, Boehringer Ingelheim, the maker of Pradaxa, said that 260 reports of fatal bleeding among Pradaxa patients had been made worldwide between March 2008 and October 31, 2011.  The drugmaker maintained that the number was in line with expectations for bleeding events based the drug's clinical trials.

According to the FDA Drug Safety Communication, bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies. In a large clinical trial involving 18,000 patients that compared Pradaxa and warfarin, major bleeding events occurred at similar rates with the two drugs, the FDA said.  The agency also noted that the Pradaxa label does bear a warning about this potentially serious bleeding.

Despite the new safety review, the FDA said it continues to believe that Pradaxa "provides an important health benefit when used as directed". It has advised patients taking the drug not to stop taking without talking to their doctor.

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