NZ officials under fire over Pradaxa side effects

New Zealand drug regulators are in the hot seat after two patients using Boehringer Ingelheim's new blood thinner Pradaxa died and 36 others suffered severe bleeding. NZ's Pharmac added the new anticoagulant to its formulary without any restrictions, a move that put patients at unnecessary risk, some doctors now say.

The agency says Pradaxa's safety was fully evaluated before it was added to the Pharmac formulary. Medical director Peter Moodie told Radio New Zealand the agency knew about Pradaxa's bleeding risks, and that Pharmac did 14 months of research before putting the drug on its funding schedule. Some 6,000 to 10,000 patients in New Zealand are using the drug, Moodie said.

But some medical experts said Pharmac didn't take enough care in educating doctors about prescribing the Boehringer drug before it went into general use. "It was rolled out very rapidly without a lot of forethought and planning," the Hematology Society's Humphrey Pullon told the Sunday Star Times. "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."

As the Star-Times reports, some NZ docs apparently prescribed the warfarin alternative to patients with kidney problems. However, Pradaxa isn't intended for use in people whose kidney function is impaired. Pullon suggests that volume-based discounts offered by Boehringer induced Pharmac to open up prescribing too quickly. For its part, Pharmac said docs weren't given any incentives to prescribe the new drug.

The New Zealand reports come a few weeks after Japanese officials issued a safety advisory warning of bleeding side effects; 5 patients using the drug had died, and regulators said they couldn't rule out Pradaxa as a cause of their deaths. Four of the patients were older than 80, and the fifth had impaired kidney function. Boehringer has suggested doctors test and monitor patients' kidney function to make sure Pradaxa use was appropriate for them.

- read the Radio NZ story
- get more from the Star-Times
- see the Pharmalot post