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Pradaxa Adverse Event Reports to FDA Raise Concern

Oct 24, 2011 | Parker Waichman LLP

A drug monitoring group is raising yet another red flag about Pradaxa.  According to the Institute for Safe Medication Practices (ISMP), since its October 2010, Pradaxa has been named in more U.S. Food & Drug Administration (FDA) Adverse Event Reports than more than 98% of the medications the group monitors. 

This isn't the first time Pradaxa has caused safety concerns.  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. As of a month ago, CARM had been alerted to four deaths; however, it said none were caused by Pradaxa.  In Japan, Boehringer Ingelheim was ordered 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. According to Reuters, five of those patients died.

According to the ISMP, within 12 weeks of initial marketing approval, Pradaxa was the suspect drug in 307 reported serious adverse events.  Most of the adverse event reports involved serious bleeding or blood clots in the elderly.

The ISMP report also found Pradaxa is already being used off-label.  It was approved to prevent stroke in people with atrial fibrillation, but only a third of prescriptions written for it have been for such patients.  It seems doctors are adopting Pradaxa as a more general use blood thinner, and using it in the same way warfarin is used.

Pradaxa is thought to have advantages over warfarin, especially because it does not interact with certain foods like that medication does.  However, there is no antidote for Pradaxa bleeding, while bleeding side effects from warfarin can be stopped by the administration of vitamin K.

According to the ISMP, during the period covered by the report, warfarin was among those with fewer FDA side effects than Pradaxa.

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