FDA Warnings Link MULTAQ Heart Drug to Severe Liver Injury
Federal health officials are warning doctors and patients of liver injuries tied to the heart drug Multaq. The FDA recently received several reports of liver damage from patients taking the drug, including two cases in which patients had to have their livers removed.
More than a half-million patients worldwide have been prescribed Multaq since it was cleared for sale in 2009. The drug, by French pharmaceutical giant Sanofi-Aventis, is used to treat irregular heart rhythms that can reduce blood flow and lead to stroke.
Multaq already carries a black box warning, the most severe type, stating that the drug can be fatal for patients with severe heart failure. Now the FDA is adding a new warning about the risk of liver damage associated with the drug after two patients suffered acute liver failure and required a transplant. Both patients were women about 70 years of age and doctors could find no other reason why they would have sustained that degree of damage.
European regulators are working closely with Sanofi to review the drug and issued letters to patients recommending liver function testing. Possible side effects of severe liver injury that patients should be aware of include nausea, vomiting, and fever.