According to the The Sunday Star Times, the Centrefor Adverse Reactions Monitoring had, by Sept. 13, received some 50 reports ofpeople experiencing severe bleeding. Other patients, mostly older than 75, haveexperienced symptoms such as coughing up blood, rectal bleeding and bleedingaround the brain, the newspaper noted. Reportedly, some of those peopleimproved simply after they stopped taking Pradaxa but others needed multipleblood transfusions or surgical intervention.
"We do have concerns about the way it was rolled out,"Humphrey Pullon of the Haematology Society of Australia & New Zealand toldthe newspaper. "It was rolled out very rapidly without a lot of forethought andplanning. In particular the fact that general practitioners could havewidespread access to this drug from day one was a concern to us, when some ofthem did not know how to use it."
Pullon said Pharmac was warned Pradaxa could cause bleedingand maintained that guidelines along those lines appeared as "an afterthought."New Zealand's Medsafe agency told the paper Pradaxa's benefits outweigh itsrisks, but is "closely monitoring the safety" and would follow the results ofongoing safety studies being conducted by Boehringer Ingelheim.
Pharmac has said that Pradaxa's safety was fully evaluatedbefore it was added to the formulary and that it and Medsafe are taking reportsseriously, but seems reluctant to sign on to the sentiment of some physiciansthat adding the new anticoagulant to its formulary without any restrictions mayhave put patients at unnecessary risk. Pharmac points out that it did 14 monthsof research on the drug before adding it and that between 6,000 and 10,000patients in New Zealand are using it.
One complaint coming to the fore is that some physicians,perhaps because of the lack of restrictions or unclear warnings, may haveprescribed the drug, which is intended as a warfarin replacement, to patientswith kidney problems—this despite the fact Pradaxa isn't intended for use inpatients if they have impaired kidney function is impaired.
This isn't the first country to experience some stumblingblocks with Pradaxa use as the drug has gained momentum—in August BoehringerIngelheim got the nod from European authorities to sell the drug as a stroke-preventiontreatment in atrial fibrillation patients, following European approval toprevent blood clots in patients who've had joint replacement surgery and anearlier stroke prevention approval in the United States, with estimates thatPradaxa will reach sales of $1.3 billiona year on stroke-prevention alone. But that August approval in Europe wasfollowed a few weeks later by Japanese regulators asking Boehringer Ingelheimto notify physicians about potentially deadly bleeding in some Pradaxapatients, according to a story from Reuters.
In fact, Japanese regulators maintained that physicians notonly needed to be warned about the bleeding risks of the drug—marketed asPrazaxa in Japan—but also that no remedy exists to counteract bleeding once itbegins—unlike with warfarin, for which vitamin K can quickly be administered ifbleeding ensues.
Another stumbling block for Pradaxa was the decision by theUnited Kingdom's National Institute for Health and Clinical Excellence (NICE)on Aug. 17 to ask Boehringer Ingelheim for more information on the drug becauseNICE wasn't convinced Pradaxa was cost-effective, at least not using the dataBoehringer had provided at that point. NICE felt that perhaps Boehringer hadoverestimated the costs of monitoring patients on warfarin, thus overstatingthe cost-effectiveness of Pradaxa, which reportedly has virtually no need formonitoring, making it easier for patients to take.