Government defends drug after severe reactions

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The Government drug agency has defended a new blood-thinning drug after hundreds of suspected adverse reactions, including 10 deaths.

A Medsafe report this month said that since Pradaxa was fully funded in July the Centre for Adverse Reactions Monitoring (Carm) in Otago fielded at least 295 reports of suspected adverse reactions.

The drug, also known as dabigatran, is thought to be used by about 10,000 mostly elderly patients and has been linked to the hospitalisation of 55 patients, and the death of 10.

Bleeding was identified as a possible adverse reaction in 65 per cent of the 78 cases deemed to be serious.

But Peter Moodie, Pharmac's medical director, said the reports were of suspected adverse reactions, and Carm had found all deaths were unrelated to treatment with Pradaxa.

Dr Moodie said Pharmac worked closely with Medsafe and other organisations to monitor the drug and the reports were consistent with data from clinical trials.

"I would not minimise the importance of people making these observations to Carm ... by people reporting them, if there is a pattern building up, then the good thing is that we're able to identify it.

"But we don't see a pattern there which indicates a source for concern as far as the safety of the drug is concerned."

Pharmac decided Pradaxa would replace warfarin as the preferred treatment to prevent blood clotting in suitable patients, as it said it was better tolerated and can be used by more people.

Dr Moodie said because it was a new drug and a focus of interest Pradaxa had generated plenty of reports, and this had to be kept in mind when comparisons were made with warfarin.

"It's difficult to get similar reports for warfarin, because it's a drug that's been around for so long.

"These drugs tend to be used in older patients ... that are more prone to have adverse events ... in an ideal world nobody would have any adverse reactions to any drugs, but that's just not the reality."

The reports were not cause for a review on the funding of Pradaxa or its use by New Zealanders, he said.

There are no restrictions on who can prescribe Pradaxa, which has led to organisations such as the Pharmaceutical Society voicing concern that GPs would underestimate risks associated with it.

Muriel O'Neale's husband Reg, 84, was switched from the old drug Warfarin to Pradaxa in July. Mrs O'Neale said he died an "undignified death" in September suffering bleeds which put the Masterton man in nappies.

She accepts that her late partner had long had ill health with chest and kidney problems but still has her suspicions that Pradaxa played some part in his death despite the report's findings.

"Well, he had been an ill man over the years but when they put him on that drug, he just went downhill. Why take him off the Warfarin when he'd been on it for five years and it was doing him alright?

"I've lost my husband - whether we would have had him much longer I don't know but I just felt he didn't deserve to go like he did. He just cried and cried. He said 'I don't know what they're doing to me. I'm bleeding and they've put a nappy on me.' He was gone within two days."

She backed a coroner's call for an inquiry into the drug.