Athena Heart [310] -

Following the ATHENA results, dronedarone was approved with specific administration and safety protocols. : The only recommended dose is 400 mg twice daily .

Clinicians should monitor several factors to prevent adverse outcomes: ATHENA HEART [310]

The official FDA label outlines critical safety measures based on ATHENA data: : Following the ATHENA results, dronedarone was approved with

: Classified as Category X ; it may cause fetal harm and should not be used by pregnant women. Drug Interactions : Following the ATHENA results

: To determine if dronedarone could lower the risk of hospitalization due to cardiovascular events or death from any cause in patients with atrial fibrillation (AF) or atrial flutter (AFL).

Monitor closely if the patient is also taking warfarin, as dronedarone can increase warfarin exposure. 4. Patient Monitoring