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Boehringer Ingelheim blood-thinning drug Pradaxa raises side effect concerns in New Zealand
09-13-2011
by Jeffrey Bouley  |  Email the author

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INGELHEIM, Germany—New Zealand health officials are taking heat and a  Boehringer Ingelheim drug is getting some slightly bad press thanks to two deaths and at least several dozen elderly patients suffering severe bleeding, apparently as a result of taking the company's blood-thinning drug Pradaxa. This just three months after New Zealand's pharmaceutical management agency, Pharmac, decided to put the drug in its formulary without any restrictions.  
 
According to the The Sunday Star Times, the Centre for Adverse Reactions Monitoring had, by Sept. 13, received some 50 reports of people experiencing severe bleeding. Other patients, mostly older than 75, have experienced symptoms such as coughing up blood, rectal bleeding and bleeding around the brain, the newspaper noted. Reportedly, some of those people improved simply after they stopped taking Pradaxa but others needed multiple blood 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 told the newspaper. "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."  
 
Pullon said Pharmac was warned Pradaxa could cause bleeding and maintained that guidelines along those lines appeared as "an afterthought." New Zealand's Medsafe agency told the paper Pradaxa's benefits outweigh its risks, but is "closely monitoring the safety" and would follow the results of ongoing safety studies being conducted by Boehringer Ingelheim.  
 
Pharmac has said that Pradaxa's safety was fully evaluated before it was added to the formulary and that it and Medsafe are taking reports seriously, but seems reluctant to sign on to the sentiment of some physicians that adding the new anticoagulant to its formulary without any restrictions may have put patients at unnecessary risk. Pharmac points out that it did 14 months of research on the drug before adding it and that between 6,000 and 10,000 patients 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 have prescribed the drug, which is intended as a warfarin replacement, to patients with kidney problems—this despite the fact Pradaxa isn't intended for use in patients if they have impaired kidney function is impaired.  
 
This isn't the first country to experience some stumbling blocks with Pradaxa use as the drug has gained momentum—in August Boehringer Ingelheim got the nod from European authorities to sell the drug as a stroke-prevention treatment in atrial fibrillation patients, following European approval to prevent blood clots in patients who've had joint replacement surgery and an earlier stroke prevention approval in the United States, with estimates that Pradaxa will reach sales of  $1.3 billion a year on stroke-prevention alone. But that August approval in Europe was followed a few weeks later by Japanese regulators asking Boehringer Ingelheim to notify physicians about potentially deadly bleeding in some Pradaxa patients, according to a story from Reuters.
 
In fact, Japanese regulators maintained that physicians not only needed to be warned about the bleeding risks of the drug—marketed as Prazaxa in Japan—but also that no remedy exists to counteract bleeding once it begins—unlike with warfarin, for which vitamin K can quickly be administered if bleeding ensues.
 
Another stumbling block for Pradaxa was the decision by the United Kingdom's National Institute for Health and Clinical Excellence (NICE) on Aug. 17 to ask Boehringer Ingelheim for more information on the drug because NICE wasn't convinced Pradaxa was cost-effective, at least not using the data Boehringer had provided at that point. NICE felt that perhaps Boehringer had overestimated the costs of monitoring patients on warfarin, thus overstating the cost-effectiveness of Pradaxa, which reportedly has virtually no need for monitoring, making it easier for patients to take.
 
Code: E09141102

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