Liver damage reports with Sanofi drug
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FDA warns of liver damage reports with Sanofi drug

FDA warns of rare but dangerous liver damage with Sanofi’s heart drug Multaq

On Friday January 14, 2011, 10:13 am

WASHINGTON (AP) — Federal health officials are warning doctors and patients that a recently-launched heart drug from Sanofi-Aventis SA has been linked to liver damage in a handful of patients.

The Food and Drug Administration said it has received several reports of liver damage with Multaq tablets, including two cases in which patients had to have their liver removed.

The FDA approved Multaq in 2009 to treat atrial flutter and atrial fibrillation which are irregular heart rhythms that can reduce blood flow and lead to stroke.

In an online notice, the FDA said it would add a new warning about the risk for liver damage to the label of Multaq. The agency said patients should contact their doctor if they experience signs of liver injury, including nausea, vomiting and fever.

Source: Associated Press