The MHRA has clarified the contraindications and monitoring requirements for switching patients to dabigatran, including those who should not be put on the anticoagulant.
Following an international review of data on the risks of haemorrhage associated with dabigatran, the medicines regulator has issued updated advice about the warfarin alternative in its latest Drug Safety Update.
It warns that the drug is now contraindicated with dronedarone and with the use of other anticoagulant agents, except when a patient's therapy is being switched to or from dabigatran ‘or with the use of unfractionated heparin for maintenance of venous or arterial catheter patency'.
Doctors are also being reminded that the renal function of all patients should be assessed before they are prescribed dabigatran, while those over 75 years old or with a suspected decline in renal function should be assessed at least once a year.
When switching to dabigatran, the MHRA recommends the first dose of the drug should be given zero to two hours prior to the time that the next dose is due, or at the time that the alternative treatment is discontinued.
For patients switching from warfarin to dabigatran, warfarin should be stopped first and dabigatran can then be given as soon as the INR is less than 2.0.
