COMUNICADO: FDA Approves Multaq(R) for Patients With Atrial Fibrillation or Atrial Flutter (y 2)

 

COMUNICADO: FDA Approves Multaq(R) for Patients With Atrial Fibrillation or Atrial Flutter (y 2)

Actualizado 02/07/2009 12:08:40 CET

Multaq(R) is contraindicated in patients with NYHA Class IV heart failure or NYHA Class II-III heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic. In a placebo-controlled study in patients with severe heart failure requiring recent 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. Atrial fibrillation is a complex disease that increases the risk of stroke up to five-fold, worsens the prognosis of patients with cardiovascular risk factors, and doubles the risk of mortality. Atrial flutter, another type of arrhythmia generating in the atrium, occurs less frequently, and may evolve into atrial fibrillation.

About sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Forward Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include product development, product potential projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMEA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such products candidates, the absence of guarantee that the products candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives as well as those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2008. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.

FOR MORE INFORMATIONS PLEASE VISIT:

Multimedia News Release: http://www.prnewswire.com/mnr/multaq/37750/

Dronedarone press office: http://www.dronedarone-atrial-fibrillation-pressoffice.com

MEDIA CONTACT: Corporate, Philippe BARQUET, Tel: +33(0)6-70-48-61-28, Email: philippe.barquet@sanofi-aventis.com; US, Marisol PERON, Tel: +1-908-981-6565, Mobile: +1-908-672-9051, Email: marisol.peron@sanofi-aventis.com

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