Federal health officials have added new safety warnings to the Sanofi drug Multaq after company studies linked the heart drug to higher rates of heart attack, stroke and death in a subset of patients.
The new label highlights two studies 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 label stresses that Multaq is only approved for the short-term form of the condition and a related ailment known as atrial flutter. Doctors routinely prescribe drugs for unapproved conditions.
The new label is the latest safety setback for Multaq, which Sanofi once touted as a potential blockbuster. Multaq already carries a warning that the drug should not be used by heart failure patients.