The FDA has told that Sanofi must add a black box warning to Multaq, taking this action after a company study linked the tablet to higher rates of heart attack, stroke and death in a subset of patients.The boxed warning will possibly address the results of a study in which Multaq doubled the risk of heart-related complications in patients with permanent atrial fibrillation, a condition in which the heart's chambers pump out of sync. The revised label stresses that Multaq is only approved for the short-term form of the condition and a related ailment known as atrial flutter. Despite such language, doctors routinely prescribe drugs for conditions not listed on the labeling approved by the Food and Drug Administration.
The label, written by the FDA in cooperation with drugmaker Sanofi, instructs physicians to check patients' heart rhythm at least once every three months. If patients appear to have the permanent form of atrial fibrillation, Multaq should be discontinued.
The FDA said Monday that Multaq remains a beneficial drug when used appropriately.