FDA Drug Safety Communication on Dronedarone and Acute Liver Failure

According to this FDA podcast, on January 14, 2011, the FDA issued a Drug Safety Communication “alerting healthcare professionals and patients about cases of rare, but severe liver injury, including two cases of acute liver failure leading to liver transplant in patients treated with the heart medication dronedarone, marketed as Multaq.”

The podcast reports that FDA has received “several case reports of hepatocellular liver injury and hepatic failure in patients treated with dronedarone, including two post-marketing reports of acute hepatic failure requiring transplantation. Because these reactions are reported voluntarily from a treatment population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.”

The full version of the podcast includes additional detailed information about these two cases of acute hepatic failure requiring transplantation, as well as FDA recommendations to physicians and other health care professionals regarding the use of dronedarone/Multaq.

Click here to access and download this third-party podcast resource.