New Zealand Pradaxa Deaths Under Investigation

A New Zealand coroner’s investigation has been initiated into deaths linked to the blood thinner, <"">Pradaxa. The most recent death of a man from the Bay of Plenty area brings the total number of New Zealand patients who have died after taking Pradaxa to five, said TVNZ.

Wallace Bain, the Bay of Plenty regional coroner with 40 years pharmaceutical experience and the former vice-president of the Pharmaceutical Society, initiated the investigation into the deaths. All of the deaths were signed off without a coroner’s hearing and all involved the elderly, noted TVNZ.

According to the Sunday Star-Times, the Centre for Adverse Reactions Monitoring (Carm) at Otago University said it was aware of four deaths; however, it remains unclear if these four comprise the Bay of Plenty five, said TVNZ. A relatively new blood thinner, Pradaxa (dabigatran), is manufactured in New Zealand by Boehringer Ingelheim and has been linked to some dangerous side effects. We previously wrote that, in New Zealand, drug regulators are facing criticism over Pradaxa’s approval.

Pradaxa’s availability increased this summer after Pharmac - the Pharmaceutical Management Agency of New Zealand - announced it was fully funding the blood thinner following a drug company deal valued at upwards of $155 million over five years, said TVNZ. As we’ve written, although Pharmac claims that Pradaxa was fully evaluated before being added to its formulary, medical director Peter Moodie told Radio New Zealand that Pharmac was aware of the bleeding risks linked to Pradaxa, Moodie said Pharmac conducted research for 14 months before the controversial anti-coagulant was added to its funding schedule; between 6,000 and 10,000 New Zealand patients take Pradaxa, said to Fierce Pharma.

Despite what Pharmac says, some experts say the agency did not sufficiently advise physicians about Pradaxa prior to its being marketed for general use. “It was rolled out very rapidly without a lot of forethought and planning,” Humphrey Pullon of the Hematology Society told the Sunday Star Times, reported FiercePharma previously.

Although MedSafe feels Pradaxa’s risks are outweighed by its benefits, TVNZ wrote that dozens have reported adverse reactions that include gastro-intestinal issues and serious bleeds that necessitate multiple blood transfusions. Also, says, TVNZ, the month-long investigation has revealed issues about Pradaxa in the medical community, such as that the drug cannot be monitored and that there is no antidote for a major bleed. There is some proof that physicians are prescribing the drug to high-risk patients, such as those over the age of 75 with kidney function issues, lower rate, and replacement heart valves, said TVNZ.

Bain said that after reading about Pradaxa’s adverse reactions in the Star-Times, he decided to open an investigation, said TVNZ. Bain will review medical and toxicology reports to determine if formal coroner’s hearings are called for. Bain said the attending physicians signed off on the deaths in most cases, which means a coroner was not notified, explained TVNZ. Bain will also review the clinical trials conducted by drug company, Boehringer Ingelheim, prior to Pradaxa’s release.

As we’ve recently written, two Pradaxa patients reportedly died and 36 others suffered from significant bleeding after New Zealand’s Pharmac included Pradaxa on its formulary with no restrictions. Physicians say this move has put patients at needless risk. In Japan, officials issued a safety warning concerning Padraxa’s bleeding side effects following five deaths in which regulators were unable to rule the drug out as a cause of death.

According to InPharm, Boehringer Ingelheim was “heavily censured” by the Prescription Medicines Code of Practice Authority (PMCPA).

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