Method to manage the risk of liver injury in patients receiving treatment with dronedarone or pharmaceutically acceptable salts thereof by performing the following steps: performing liver function tests prior to treatment with dronedarone, monitoring liver function monthly for six months, at months 9 and 12, and periodically thereafter, if alkaline phosphatase (ALT) levels are elevated higher than three times the upper limit of normal, re-measuring levels if confirmed to be greater than three times the upper limit of normal, withdrawing administration of dronedarone, continuing close observation until normalization of ALT and, investigating the probable cause, including those related to underlying cardiac conditions.
