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news.The US Food and Drug Administration (FDA) has notified health professionals and patients about the potential risk of liver injury associated with the heart medication - Multaq (dronedarone).
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Dronedarone is indicated for the treatment of abnormal heart rhythm in patients who have had an abnormal heart rhythm during the past six months.
According to the FDA, cases of rare but severe liver injury, including two cases of acute liver failure leading to liver transplant in patients treated with dronedarone, were reported.
Information about the potential risk of liver injury is being added to the warnings and precautions and adverse reactions sections of the dronedarone labels.
The FDA has recommended the health professionals to remind the patients to contact a healthcare professional immediately if they experience signs and symptoms of hepatic injury or toxicity while taking dronedarone.
In addition, health professionals should consider obtaining periodic hepatic serum enzymes, especially during the first 6 months of treatment.