Pharmac‘s blood thinner drug caused fatalities in addition to adverse effects.

The blood thinning drug by Pharmac has left dozens of elderly patients suffering from bleeding, in addition to 2 fatalities, after the drug was hurriedly launched in to the market in a deal amounting to more than $100 million.
Some physicians opine that the government drug funding agency, Pharmac, has taken a risk with the lives of many patients by supporting Pradaxa (dabigatran), even before establishing its side effects.

An oral anti-clotting drug, Pradaxa, was designed to decrease stroke risk in people with arrhythmias, and act as a blood thinner for clot prevention in people undergoing hip or knee replacements.

Since the time (2 months ago) Pradaxa was substituted for the standard blood thinner warfarin, the Centre for Adverse Reactions Monitoring (Carm) is in receipt of 50 reports regarding people suffering from bleeding. Thousands of patients have been switched over to warfarin, in view of the fact that nearly 56,000 people take warfarin.

Although there is no clear picture of the number of fatalities, the Sunday Star-Times has noted that 2 elderly patients (a man and a woman) have succumbed to death by bleeding.

Several other elderly patients (above 75 years) have reported symptoms including coughing up blood, rectal bleeding, and bleeding around the brain. While the condition of some patients improved on Pradaxa withdrawal, others required multiple blood transfusions for stabilization. In some cases, patients endured major complications in surgery. For instance, surgery for an 84-year-old man who had suffered a hip fracture got delayed by 9 days owing to complications associated with Pradaxa.

Although bleeding is a known risk associated with the administration of anti-clotting drugs, physicians fear that there might not be any treatment to reverse the effects of Pradaxa, unlike warfarin, which can be quickly reversed by administering another drug. One surgeon, who wanted to maintain anonymity, opined that clinicians must refrain from prescribing Pradaxa.

In an announcement made in June, Pharmac declared that Pradaxa was a “game changer,” and that the company would fund it entirely without restriction, implying that any clinician could prescribe it. Pharmac had signed a deal with drug company Boehringer Ingelheim which could cost $155m over five years, although this will drop through rebates.
Humphrey Pullon of the Hematology Society commented, “We do have concerns about the way it was rolled out. It was rolled out very rapidly without a lot of forethought and planning. 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.”

Investigations by hematologists have revealed that general practitioners have been prescribing Pradaxa to individuals, such as those with poor kidney function, who should never be administered this drug.

In a statement, Medsafe declared that benefits of Pradaxa prevailed over the risks. The safety of Pradaxa was being closely monitored, and that it would consider the results of a number of ongoing safety studies undertaken by Boehringer Ingelheim.

Carm should get a full report of any suspected adverse reactions, and patients with concerns regarding the drug should consult their doctors.

In a statement, Pharmac announced that Medsafe had decided Pradaxa was safe to register in New Zealand.
“As with all adverse events, both Pharmac and Medsafe take these reports very seriously. In addition to the normal safety nets, the hematologists’ reporting system is proving to be invaluable and the results are being monitored by all agencies.”

Palmerston North hematologist Paul Harper, who has been running the reporting system, said that it was a tad bit late to initiate efforts towards AE management considering that the drug has been marketed for 2 months now.

Harper said, “The drug came in much quicker than we expected and there hasn’t been much opportunity to really educate people about how to use it. We haven’t really got anything helpful to reverse the effects of the drug, and that’s the big concern. If someone does have a significant bleed we haven’t got a good way of managing that.”
Pradaxa is not superior warfarin in its action. However, unlike warfarin, it does not necessitate the regular blood test, which is perceived by Pharmac as a major cost-saver.

Harper said that there was not much information regarding Pradaxa since only one clinical trial was conducted internationally. Fatalities have also been reported in Japan and the US.

The drug has been funded entirely by New Zealand. Some doctors have voiced concerns that Pharmac has given precedence to commercial benefits over patient safety.

Pullon said: “I think there were certain commercial pressures whereby in order to generate adequate volumes and generate the savings they really had to open it up to … GP prescribing. That’s a commercial risk that Pharmac entered into. It certainly wasn’t done with any consultation with the society.”

In a statement, Pharmac said, “There is no incentive for any clinician to maximize prescribing of this medicine. There is a substantial cost to the pharmaceutical budget from the prescribing of this medicine.”

It also added that it sought clinical advice and took 14 months to make a decision regarding Pradaxa.

According to Harper’s investigation, Pradaxa is unsuitable in certain doses for people aged 75 and above. It causes problems in people with poor kidney function, low weight, and heart-valve replacements, in addition to those switching between Warfarin and Pradaxa too quickly.

Pullon remarked that Pharmac was warned by the hematology society that Pradaxa could induce bleeding. “They then gathered a group of hematologists … and generated some guidelines as to how the drug should be used. It was a bit of an afterthought.”