FDA approves drug to maintain normal heart rhythms

July 6, 2009

The Food and Drug Administration has approved Multaq 400 mg tablets to help maintain normal heart rhythms in patients with a history of atrial fibrillation or atrial flutter.

The Food and Drug Administration has approved Multaq 400 mg tablets to help maintain normal heart rhythms in patients with a history of atrial fibrillation or atrial flutter.

The drug was approved for use in patients whose hearts have returned to normal rhythm or who will undergo drug or electric-shock treatment to restore a normal heartbeat.

Multaq is an anti-arrhythmic indicated to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted, according to a statement from Sanofi-Aventis.

Multaq may cause critical adverse reactions, including death, in patients with recent severe heart failure.The drug’s label will contain a boxed warning, the FDA’s strongest warning, which says the drug should not be used in patients with severe heart failure.

In a multinational clinical trial involving more than 4,600 patients, Multaq reduced cardiovascular hospitalization or death from any cause by 24 percent, when compared with a placebo. Most of that effect represents reduced hospitalizations, especially hospitalizations related to atrial fibrillation. Atrial fibrillation and atrial flutter cause the heart to beat abnormally fast and sometimes prevent blood from being properly pumped out of the heart.

The most common adverse reactions reported by patients in clinical trials were diarrhea, nausea, vomiting, fatigue and loss of strength. For more information, visit www.sanofi-aventis.us.