FDA has asked for additional warning on the label of Multaq.

The U.S. Food and Drug Administration (FDA) had completed a safety review of the drug Multaq or dronedarone and this safety announcement was a result of this review.

Multaq was approved by U.S. Food and Drug Administration for treatment of cardiac arrhythmia in 2009. Multaq is manufactured by Sanofi-Aventis, the Paris based pharmaceutical giant. The U.S. Food and Drug Administration approved Multaq tablets to help maintain normal heart rhythms in patients, who have a history of heart rhythm disorders such as atrial fibrillation or atrial flutter. It contains Dronedarone as main active ingredient.

Clinical trials have shown that Multaq reduced cardiovascular hospitalization or death by 24 percent. It has shown positive result especially in patients having history of atrial fibrillation. Heart rhythm disorders such as atrial fibrillation and atrial flutter could prevent pumping of blood out of the heart. Though FDA asked for a boxed warning asking patients to not use this drug in severe heart failure patients as Multaq may cause critical adverse reactions, including death, in patients with recent severe heart failure.

FDA issued a Drug Safety Communication in January 2011, which informed the healthcare professionals as well as patients about cases of rare but severe liver injury caused due to use of Multaq.

The U.S. Food and Drug Administration (FDA) issued a safety announcement on 21st July 2011 after is evaluating the effects of the drug Multaq or Dronedarone in patients with permanent atrial fibrillation. The study found the doubling of risk of death, stroke and hospitalization in permanent atrial fibrillation patients, who were using Multaq compared to patients taking another anti arrhythmia drugs.

FDA asked patients to consult their doctor about alternative medication or evaluation of use of Multaq in them. It also asked them to report any adverse event to the FDA MedWatch program. It asked doctors to not prescribe Multaq to patients with permanent atrial fibrillation and report adverse events involving Dronedarone or Multaq to the FDA MedWatch program. FDA was continuing its review on side effects of Multaq.

Recently FDA issued another safety announcement on 19th December 2011 related to Multaq after completing a safety review of Multaq or Dronedarone. FDA asked doctors to not prescribe Multaq to patients with Permanent Atrial Fibrillation, because Multaq could double the risk of cardiovascular death, stroke, and heart failure in such patients. They should monitor their patients using Multaq by electrocardiogram (ECG) at least once every 3 months. Patients, who have been prescribed with Multaq, should be given appropriate anti thrombotic therapy alongside. It asked patients to consult their doctor about any questions or concerns about Multaq. Patients should not stop taking Multaq without consulting their doctor.

FDA is further reviewing the risk evaluation and mitigation strategy (REMS) for Multaq. It is doing so to find out the necessary changes to ensure safety of Multaq in patients of atrial fibrillation. It is trying to find out changes, which could make the benefits of Multaq outweigh the risks of cardiovascular death, stroke, and heart failure. Further information from this study is awaited.