- Prescribing Advice for GPs - https://www.prescriber.org.uk -

Dabigatran product information update

The European Medicines Agency (EMA) has recommended (PDF) several updates to prescriber and patient information for dabigatran (Pradaxa®).

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:

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.