New Sanofi heart pill may cause liver damage, FDA cautions

FDA: Sanofi heart pill may cause liver damage

Some reports of liver damage caused by Sanofi-Aventis SA's new heart drug Multaq have been received by the U.S. Food and Drugs Administration, officials said today. The extent of the damage was severe enough in two female, elderly patients that their livers needed to be removed. One patient was taking Multaq for 4.5 months while the other patients was taking it for about six months.

Sanofi received approval for Multaq in July 2009. The drug is indicated for patients with abnormal heart rhythms such as atrial fibrillation and atrial flutter. An estimated 500,000 prescriptions for Multaq have been made since the drug was approved. The drug firm reported sales of the drug worth $84 million for the first six months of 2009.

The FDA said in its web site that Multaq labels will need to be revised to reflect the increased risk of liver damage. The warning said that patients taking Multaq should report to their physicians symptoms of fever, nausea and vomiting which indicate liver damage. The FDA urged doctors to check liver enzymes and discontinue the drug if liver damage is likely.

Multaq has a black box warning that says that the drug can cause serious complications, even death, for heart failure patients. The pill is usually taken twice daily. Documented side effects include weakness, fatigue, nausea, vomiting and diarrhea.

"Sanofi-Aventis will continue to be in communication with the FDA and this issue will be closely reviewed and monitored," the drug maker said in a statement. It said it had sent letters to physicians about the risk of liver damage posed by Multaq.

Posted by George Daniels on Wednesday January 19 2011, 12:54 AM EDT. Ref: AP. All trademarks acknowledged. Filed under Featured News, Health. Comments and Trackbacks closed. Follow responses: RSS 2.0