The manufacturer of dronedarone (Multaq®) has written to healthcare professionals warning of severe liver injury associated with use of the drug. The Medicines and Healthcare products Regulatory Agency (MHRA) have also issued a warning (PDF).
Dronedarone is licensed for use in clinically stable patients with a history of or current non-permanent atrial fibrillation (AF) to prevent recurrence of AF or lower ventricular rate.
Cases of liver injury have been reported with 2 cases requiring transplantation. Liver function tests are advised before starting treatment, on a monthly basis for 6 months, at 9 and 12 months after initiation and periodically thereafter. Patients who are already on treatment should also undergo liver function testing based on this advised frequency of testing.
If alanine transferase (ALT) is elevated to greater than three times the upper limit of normal the level should be rechecked within 48-72 hours and if confirmed treatment should be withdrawn.
Action: Clinicians should be aware of this warning and the new monitoring requirements. The manufacturer will be updating the prescribing information shortly.