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New Zealand Deaths Put Pradaxa in Spotlight

Oct 4, 2011 | Parker Waichman LLP

A coroner in New Zealand is investigating several deaths among Pradaxa patients.   According to a report from the New Zealand Star-Times, at least five Pradaxa patients- all elderly - have died there.  

There does appear, however, to be some confusion on the exact number of deaths.  New Zealand's Centre for Adverse Reactions Monitoring (CARM) at Otago University says it has received reports of 4 deaths, but the Star-Times couldn't determine if those reports include any of the five fatalities it recently learned of.

According to the report, Bay of Plenty regional coroner Wallace Bain has decided to investigate the five confirmed deaths, after expressing concern that they were signed off without coroner's hearings.

CARM director Michael Tatley told the Star-Times that the deaths his centre had investigated were caused by factors other than Pradaxa, such as infections.  But some family members apparently disagree, telling the Star-Times that there relatives died after they switched from warfarin to Pradaxa, and infections set in only after their conditions had deteriorated to the point of hospital admission.

"We all feel certain that had my father remained on warfarin, he would still be sitting in his garden in the sun today and looking forward to Christmas with his family," said Chris Thompson, whose 77-year-old father, Rod, died in Tauranga Hospital last Sunday.

Pradaxa is a blood thinner approved to prevent strokes in people with atrial fibrillation.  According to a Reuters report, Pradaxa has been on the U.S. market since late last year, and is meant to replace warfarin.  Pradaxa and two similar new blood thinners are considered to be an improvement over warfarin because they do 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.

In August, regulators in Japan - where the drug is sold as Prazaxa - told Boehringer Ingelheim 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.  The Japanese health ministry also said a lower dose may have to be given to certain patient groups, such as those over 70 or with kidney damage.

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