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Pradaxa Maker Confirms Jump in Bleeding Death Reports

Nov 16, 2011 | Parker Waichman LLP

The number of bleeding deaths among Pradaxa patients has jumped five times in just a couple of weeks.  According to a report  from Reuters, Boehringer Ingelheim has confirmed 260 reports of fatal bleeding among Pradaxa patients worldwide, up from the 50 deaths the company confirmed at the start of November.

Pradaxa is approved to prevent strokes in people with atrial fibrillation.  Like all blood thinners, however, it carries a risk of bleeding.   Unlike warfarin, the blood thinner Pradaxa is intended to replace, the drug does not cause dangerous interaction with certain 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.

Boehringer Ingelheim still maintain that Pradaxa 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.

However, regulators in various countries have pushed Boehringer Ingelheim to increase warnings on Pradaxa recently.  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 told Boehringer Ingelheim to issue a warning for Pradaxa and potentially fatal bleeding after 81 patients taking it there suffered heavy bleeding.

According to a report issued by the Institute for Safe Medication Practices (ISMP), since its October 2010 approval, 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.

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