SILVER SPRING, Md. — The Food and Drug Administration and drug maker Sanofi-Aventis are warning healthcare professionals and patients about the possibility of severe liver injury in patients taking a Sanofi heart drug.
The FDA said Friday that it had found cases of liver injury, including two cases of liver failure requiring transplants, in patients taking Multaq (dronedarone), a drug used to treat abnormal heart rhythm. Multaq was approved in July 2009 with a Risk Evaluation and Mitigation Strategy, or REMS, designed to prevent its use by patients with heart failure. Since then, around 147,000 patients have filled prescriptions for the drug at retail pharmacies, according to SDI.
The announcement comes a day after a new FDA requirement for prescription painkillers containing acetaminophen to contain no more than 325 mg of the drug, also due to the risk of liver injury in patients who take more than 4,000 mg of the drug daily.