Sanofi-Aventis is about to send a “Dear Doctor” letter to physicians informing them of two cases of fulminant hepatic failure/necrosis resulting in liver transplanation in two patients taking Multaq (dronedarone), CardioBrief has learned. The two patients were women in their 70’s with no other apparent causes of liver injury or known elevations of liver function tests (LFTs) prior to the acute liver failure. Liver failure developed after the women were taking dronedarone for four to six months.
CardioBrief has also learned that Sanofi-Aventis plans to change the drug’s label and will recommend that physicians obtain LFTs at baseline prior to prescribing the drug. The company had previously informed clinical investigators working with the drug about the liver failure cases.
Sanjay Kaul sent the following response to the news:
At this time it is not clear whether the liver toxicity represents an idiosyncratic reaction or an expected side effect that can be mitigated by monitoring liver function tests. Nonetheless, the news of acute liver failure adversely alters the already tenuous benefit-risk balance of this drug and further increases my threshold to recommend this drug for clinical use.
CardioBrief has asked Sanofi-Aventis for a response. Multaq was approved by the FDA in July 2009 for the treatment of atrial fibrillation.