Medicines board says it has ‘no immediate issues’ with blood thinners despite reactions

Director of the National Centre for Pharmaco-economics says he has ‘real concerns’ about new generation of anti-coagulants


The Irish Medicines Board says it has “no immediate issues” with a number of leading new blood thinners which have been the subject of hundreds of adverse reactions since they were introduced.

The board has received 109 reports of suspected adverse reactions associated with the use of Xarelto (rivaroxaban) and 96 linked to Pradaxa (dabigatran) since they were approved in 2008, it has confirmed to The Irish Times .

Most of the reactions reported with these blood anti-coagulants, which are taken orally, are consistent with the known and expected adverse effects for such products, and mainly involve “various types of haemorrhagic effects”, a spokeswoman said.

However, Dr Michael Barry, director of the National Centre for Pharmaco-economics, said he had “real concerns” about the new generation of anti-coagulants which were replacing traditional blood treatment therapy using warfarin.

“If you come in with a major bleed and you’re on these products I may not be able to reverse it,” said Dr Barry, whose National Medicines Information Centre has written to all GPs on the issue.

Over 1,000 patients a month are being switched to the new products, which can be taken at home and involve far less monitoring than warfarin. Bleeding that could lead to serious haemorrhaging or even death was a “well-recognised complication” of all anticoagulant therapies, the IMB spokeswoman acknowledged.

For this reason, product information for these medicines provides detailed warnings, and monitoring advice and educational materials had been distributed to doctors and patients.

“Healthcare professionals and patients are advised to closely follow the recommendations in the approved product information. Stopping the use of blood-thinning medications can increase risk of stroke.”