FDA Approves Multaq(R) for Patients with Atrial Fibrillation or Atri... (hospitalization or referral to a special...)

FDA Approves Multaq(R) for Patients with Atrial Fibrillation or Atrial Flutter

Date:7/2/2009

hospitalization or referral to a specialized heart failure clinic for worsening symptoms (the ANDROMEDA study), patients given dronedarone had a greater than two-fold increase in mortality. Such patients should not be given dronedarone.

Multaq(R) is also contraindicated in second- or third-degree atrioventricular (AV) block or sick sinus syndrome (except when used in conjunction with a functioning pacemaker), bradycardia <50 bpm, QTc Bazett interval greater than or equal to 500 ms and severe hepatic impairment.

Multaq(R) should not be given to patients who are or may become pregnant (Category X) or nursing.

Multaq(R) should not be coadministered with strong CYP 3A inhibitors or medicinal products that prolong the QT interval.

In patients with new or worsening heart failure, the suspension or discontinuation of Multaq(R) should be considered.

Serum creatinine levels increase by about 0.1mg/dL following Multaq(R) treatment initiation. The elevation has a rapid onset, reaches a plateau after 7 days and is reversible after discontinuation.

Hypokalemia and hypomagnesemia may occur with concomitant administration of potassium-depleting diuretics. Potassium levels should be maintained in the normal range pre and during administration.

For full prescribing information, please visit

http://products.sanofi-aventis.us/Multaq/Multaq.pdf

About Atrial Fibrillation/Atrial Flutter

Atrial fibrillation is the leading cause of hospitalization for arrhythmia in the U.S. and represents one-third of hospitalizations for arrhythmia in Europe. Hospitalization associated with AF has increased dramatically (two-to-three fold) in recent years in the U.S. A
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FDA Approves Multaq(R) for Patients with Atrial Fibrillation or Atri...(hospitalization or referral to a special...),Health