A safety review by Health Canada has concluded there may be a link between dabigatran (Pradaxa) and liver injury.

The review, triggered by reports of severe liver injury in 27 patients, found three cases, including one death, ‘showed a possible link between liver injury and the use of Pradaxa’.

However the review said there was no evidence for an increased risk in published studies.

“This review also looked at 105 international reports of severe liver injury related to the use of Pradaxa. Of these reports, 16 were further assessed as they were suspected to be linked to the use of Pradaxa. 13 of these 16 reports, including 2 deaths, showed a possible link between liver injury and the use of Pradaxa.”

Health Canada said it would work with the manufacturer to update the safety information for Pradaxa to inform healthcare professionals and patients about this risk.

Boehringer Ingelheim Australia told the limbic it was aware of the Canadian review and had informed the TGA about its outcomes.

“In Australia, Boehringer Ingelheim is committed to maintaining an open and transparent dialogue with the TGA and routinely provides up-to-date information relating to the efficacy and safety of Pradaxa,” a spokesperson for the local regulatory team said.

They added the company has conducted diligent monitoring to detect potential liver problems throughout the drug’s clinical development and following its approval.

“The findings and results of the conducted analyses encompassing the pre-clinical development, the clinical trials and the observations from the more than eight million patient years’ of exposure worldwide following the marketing approval are absolutely consistent: Based on the available data as summarised in a Signal Assessment Report (which was shared with health authorities, including the TGA, in 2017), there is no evidence of acute liver failure or hepatotoxicity related to Pradaxa.”

Professor David Brieger, head of coronary care and coronary interventions at Concord Hospital, told the limbic there had been extra vigilance around the oral thrombin inhibitors since the failure of the first generation product ximelagatran.

“It caused this idiosyncratic injury which was infrequent but potentially fatal and basically sunk the drug.”

However he said the Canadian report was the first he had heard of any problem with dabigatran.

“As far as I’m aware there hasn’t been any signal of harm from any of these drugs yet. I’ve been looking at the literature fairly recently and I haven’t seen anything.”