GPs push blood pill says son of victim

Fairfax NZ

NO COMMENT: Harry Pert, president of the Royal New Zealand College of General Practitioners.

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Doctors hyave been "pushing" the new blood-thinning drug Pradaxa before its side-effects are fully known, says the son of a man who is fighting for his life in Tauranga Hospital after suffering an adverse reaction to the medicine.

The body representing general practitioners has admitted they are on a "learning curve" on how to use Pradaxa and it will be years before they have full knowledge of its effects.

A Sunday Star-Times investigation has found that at least four elderly heart patients have died, and dozens have suffered bleeds, after switching from the anti-clotting drug warfarin to the new-generation medicine Pradaxa, also known by its generic name, dabigatran.

Pharmac fully funded the drug from July after it was approved by government medicines regulator Medsafe, and since then many people have reported adverse reactions, ranging from gastro-intestinal problems to major bleeds. Medsafe says it had expected adverse reactions, but believes the benefits of the drug outweigh the risks.

Clinical trials have found that at certain doses, Pradaxa has lower rates of bleeding and risk of stroke than warfarin, and its other main benefit is that it does not require continual blood tests.

But it cannot be monitored and surgeons and haematologists are alarmed that there is no antidote to reverse its effects in the event of a major bleed.

GPs have been criticised in some cases for prescribing Pradaxa for patients at higher risk, such as those over 75, with poor kidney function, low weight and replacement heart valves.

The Star-Times has heard reports of medical clinics transferring patients from warfarin to Pradaxa en masse after presentations by Boehringer Ingelheim, the company which produces the drug.

Harry Pert, president of the Royal New Zealand College of General Practitioners, said he could not comment on "anecdotes", but confirmed there was enthusiasm for the new drug.

"People have been waiting for an alternative to warfarin for a long time. It's not the greatest drug, and if there's something that will do the job as well, or better, then we should be considering it."

He rejected the suggestion that patients were being used as guinea pigs. "They're not being used as guinea pigs, medicine is always changing, always progressing and we're always learning, that's the way medicine works. If you sit down and have a conversation with the patient and say `there is this new medicine, these are the potential harms and these are the potential benefits, what would you like to do?' I don't think there's a problem with that."

But Chris Thompson of Whakatane, whose 77-year-old father, Rod, is fighting for his life in Tauranga Hospital after an adverse reaction to Pradaxa, said elderly patients tended to take what their GP said as gospel, and it appeared doctors were "pushing" Pradaxa. His father, who was otherwise fit but took warfarin for a heart rhythm disorder, switched to Pradaxa on the advice of his GP.

He began suffering lower back pain, which turned out to be a kidney infection, and was eventually admitted to hospital with total renal failure. He has come close to death and remains in intensive care. Chris Thompson said two GPs who saw his father after the symptoms began did not associate them with Pradaxa, and it was not until he was admitted to hospital that the Pradaxa connection was made.

"If the GP had known more about the side-effects, monitored it more and made the changeover more gradual, they may have picked up the fact he was responding adversely to it. He got quite sick before they realised what it was. If they'd been monitoring the patients more thoroughly ...they could have taken him off it and he'd probably be fine today." The GP involved declined to comment.

Pert said the college sent material to all 4000 members on how to prescribe Pradaxa safely. "With the introduction of a new medicine, there's always going to be a learning curve as people get to grips with how to use it, when to use it and when not to. We don't want to delay unnecessarily access to a potentially important new medicine, nor do we want to rush into it."

He said that although Pradaxa was a good option to consider, evidence suggested that patients over 75 who were stable on warfarin "might be perfectly happy staying on it. It comes down to individual choice".

- © Fairfax NZ News