The debate on the safety of dabigatran continues, in light of growing reports of complications and deaths among patients taking the new anticoagulant – particularly those aged over 80.
There have been 14 deaths reported in Australia among patients taking dabigatran (Pradaxa), since it was approved for use in surgical patients in 2009, according to the Therapeutic Goods Administration.
Two hundred and three adverse events have been reported relating to dabigatran, with 124 considered serious. Of these, 47 were for bleeding, a TGA spokeswoman said.
Advanced age was a likely contributing factor as many of those who died were aged over 80 years, she said.
A spokesman for Boehringer Ingelheim, which manufactures dabigatran, said more than 20,000 patients have received the drug in Australia - it is understood the vast majority of these for AF - and the number of reported adverse events was consistent with the results from clinical trials.
Associate Professor Michael Woodward, director of aged care at Austin Health in Melbourne, said he would be “very cautious” about moving older patients to the new anticoagulant.
“We have to be very careful before we have a mass exodus from warfarin, which although it has its problems, is the devil we know,” Professor Woodward said.
“We know that warfarin is effective and reasonably well tolerated in the very elderly... If somebody is keeping their INR generally within range, then just making an automatic change to these more expensive drugs is unjustified.”
Dr Geraldine Moses, senior pharmacist on the National Prescribing Service's Adverse Medicine Events Line, said there should be concern about any deaths related to dabigatran.
“When dabigatran does get on the PBS for AF here, consumers will be stampeding to doctors’ surgeries, wanting to switch from warfarin to dabigatran,” she said.
“Reigning this in and trying to have a conservative approach to its introduction is well worth doing, and I think the PBS is trying to do that.”
New Zealand's drug funding agency came under fire this month after “rushing” dabigatran onto the market, a move which was linked to at least two deaths and significant bleeding in dozens of elderly patients.
And in Japan, the ministry of health last month issued a safety advisory on dabigatran, warning of the potential for adverse events following the deaths of five patients.
Dabigatran was recently approved for AF in Australia, and while it is awaiting a decision on PBS approval, dabigatran is available through Boehringer Ingelheim’s product familiarisation program.