Click to go to DrugInjuryLaw Home


Legal information and news about prescription drug side effects
NuvaRing Case Evaluation Ortho Evra Case Evaluation Fosamax Case Evaluation Avandia Case EvaluationKetek Case Evaluation Zelnorm Case Evaluation Meridia Case Evaluation Zocor Case Evaluation
Vytorin Case EvaluationZetia Case Evaluation Yasmin Case Evaluation Ocella Case EvaluationYAZ Case Evaluation Levaquin Case Evaluation Byetta Case Evaluation Gianvi Case Evaluation


Free Case Evaluation

Multaq: FDA Approved In July 2009 For Two Heart Rhythm Disorders, Atrial Fibrillation And Atrial Flutter

Original Package Insert, Or Label, Included "Black-Box" Warning In 2009; FDA Issues Drug Safety Alert About Liver Injury In 2011

UPDATE:  On March 11, 2011 the FDA approved a change by Sanofi-Aventis to the Multaq Prescribing Information (also known as the package insert or label); there is a new warning about various types of liver injury in the "Warnings and Precautions" section.


Multaq (dronedarone) was approved by the FDA in July 2009 to "help maintain normal heart rhythms in patients with a history of atrial fibrillation or atrial flutter." These two types of heart rhythm disorders cause the heart to beat abnormally fast and, sometimes, prevent blood from being properly pumped out of the heart. Multaq is used as maintenance drug therapy in patients whose hearts have returned to normal rhythm, or who will undergo drug or electric-shock treatment to correct the irregular heart rhythm and restore a normal heart beat.

Multaq is manufactured by the drug company Sanofi-Aventis, based in Paris, France.

The original Multaq package insert, or label, from 2009 included a so-called "black-box" warning (also called a boxed warning), the FDA's strongest safety warning, which cautioned doctors that Multaq should not be used in severe heart failure patients.

In January 2011 the FDA issued a drug safety alert for Multaq concerning severe liver injury, such as liver failure requiring liver transplantation, associated with Multaq use.

 

Go to Free Multaq Case Evaluation form >>

Read more on the Multaq Information Page >>


  • US FDA advises that you should not stop taking any prescription medication before talking to your doctor.
  • Reports of serious drug side effects should be made to the US FDA MedWatch program.
  • The prescription drug names are registered trademarks of the respective drug companies.
  • DrugInjuryLaw.com is not affiliated with any of the drug companies, nor US FDA.
Law Offices of Thomas J. Lamb, P.A.
Lumina Station Suite 225
1908 Eastwood Road
Wilmington, NC 28403
Tel: (910) 256-2971   Fax: (910) 256-2972
Toll Free: (800) 426-9535
email: ThomasJLamb@DrugInjuryLaw.com

Disclaimer