The U.S. Food and Drug Administration has revised the label on the drug Multaq, manufactured by Sanofi-Aventis , a Paris based pharmaceutical company. The change will reflect that there is a doubling health risk, including death, for patients with permanent atrial fibrillation. The FDA said, for these patients, the drug can and will double the rate of cardiovascular death, stroke and heart failure.

Multaq, known chemically as dronedarone, is still safe to treat patients with brief bouts of irregular heart rhythms. However, the FDA stresses physicians must monitor the heart rhythms of patient’s being administered Multaq, at least once every three months.

Afib, or atrial fibrillation, is when the upper chambers of the heart beat in a manner that is uncoordinated or without a steady rhythm. When this happens, there is a risk of blood pooling which can cause both life threatening blood clots and strokes. Patients with Afib can have this condition for a short time, or it can be permanent.

The FDA has approved continued, limited use of Multaq in the United States. Multaq can be used to reduce hospitalizations of patients with the short term version of Afib. However, some physicians still prescribe the medication in an ‘off-label’ manner to patients with permanent irregular heartbeats.

In a statement issued by the manufacturer, “The FDA label is meant to ensure the drug goes to the right patients. We fully agree with the FDA that patients with permanent AF should not use the product. We’re fully committed to patient safety and updating our labels whenever information comes in that would be useful.”