Pradaxa Linked to Bleeding DeathsNov 2, 2011 | Parker Waichman LLP
Since its launch last year, roughly 50 Pradaxa patients worldwide have died as a result of bleeding. Bloomberg News, quoting the German newspaper Die Zeit, reported that Boehringer Ingelheim is investigating the deaths.
Pradaxa is approved to prevent strokes in people with atrial fibrillation. Like all blood thinners, however, it carries a risk of bleeding. Boehringer maintains the number of deaths associated with Pradaxa is within the expected range.
"Fifty cases is a reasonable order of magnitude that has emerged so far," a spokesperson told Die Zeit.
According to Bloomberg, 14 of the deaths occurred in Pradaxa patients in Japan. Some of the others occurred in Germany, though the report did not say how many.
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.
Just last week, Boehringer Ingelheim agreed to notify European doctors that patients older than 75 and those with renal impairment should undergo kidney checks every year. Pradaxa is excreted through the kidneys, so impaired kidney function could lead to abnormally high levels of the drug in circulation, leading to excessive risk of 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.