Pradaxa Side Effects Raising Concerns

A relatively new blood thinner, Pradaxa (dabigatran), manufactured in New Zealand by Boehringer Ingelheim, has been linked to some dangerous side effects and, now, drug regulators there are facing criticism.

Two Pradaxa patients reportedly died and 36 other patients suffered from significant bleeding, said FiercePharma. It seems that New Zealand’s Pharmac—the Pharmaceutical Management Agency of New Zealand—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, noted FiercePharma. Also, Top News wrote that Pradaxa has been linked to stomach problems in addition to serious bleeding, leading to the death of four senior patients in New Zealand, although, according to Medsafe, which regulate drugs for the Health Ministry, no deaths were directly linked to the drug.

Although Pharmac claims that Pradaxa’s 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, said Fierce Pharma. 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. “In particular, the fact that general practitioners could have widespread access to this drug from day one was a concern to us, when some of them did not know how to use it,” Pullon added.

The Star-Times reported that some New Zealand physicians prescribed the blood thinner to kidney patients, yet Pradaxa is not meant to be taken by patients who suffer from kidney problems, FiercePharma wrote. Part of the problem is that Boehringer Ingelheim offered volume-based discounts, prompting Pharmac to allow prescribing too soon, Pullon implied, said FiercePharma. Pharmac claims physicians were not given incentives to prescribe Pradaxa.

Meanwhile, according to InPharm, Boehringer Ingelheim was “heavily censured” by the the Prescription Medicines Code of Practice Authority (PMCPA), which enforces the The Association of the British Pharmaceutical Industry’s (ABPI) Code of Practice for press release and other content. One breach—the most serious and only used by firms which brought “discredit upon, and reduced confidence in, the industry” involved articles that referred to Pradaxa’s use to prevent stroke. The drug maker submitted an application to the European Medicines Agency to extend its license for this purpose, but the drug is not currently licensed for this purposes, said InPharm.

The drug maker was also censured for “promoting a prescription-only medicine to the public for an unlicensed indication, which was inconsistent with the terms of its marketing authorization,” said InPharm. The agency also questioned Pradaxa as being described as “leading the way in new oral anticoagulants/direct thrombin inhibitors … targeting a high unmet medical need” and cited missing information on side effects. The panel also found that Boehringer encouraged patients to have their physicians to prescribe Pradaxa versus other medications, added InPharm.

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