A recent assessment of the available data, including post-marketing surveillance sources, found that reported levels of serious or fatal bleeds in the post-marketing data were lower than reported in clinical trials. This information is reassuring but dabigatran remains under close EMA surveillance.
The updated information is contained in an FAQ document and is as follows.
Clinicians are reminded to:
- Assess bleeding risk, including renal function, before staring treatment and to reassess risk on dose changes and if renal function deteriorates
- Dabigatran must not be used in patients with a lesion or condition putting them at significant risk of major bleeding
- Dabigatran must not be used in patients using any other anticoagulant, unless the patient is being switched to or from dabigatran
Additionally, patients are advised to seek urgent medical attention if they fall or injure themselves during treatment, especially if they hit their head, due to the increased risk of bleeding.
Action: Clinicians should be aware of these recommended changes to the prescribing information and implement any necessary changes to practice.