US Regulators Wary of Sanofiís Multaq , Warn of Heart Risks

by Nancy Needhima on  December 20, 2011 at 10:54 PM Heart Disease News
RSS Email Print This Page Comment
On Monday US regulators ordered Sanofi, the French pharmaceutical giant, to change the label of its heart drug Multaq after it was found to double the risk of death in certain patients.
US Regulators Wary of Sanofiís Multaq , Warn of Heart Risks
US Regulators Wary of Sanofiís Multaq , Warn of Heart Risks
Advertisement

Patients with permanent abnormal heart rhythm, or atrial fibrillation, should not take the drug -- also known as dronedarone -- because of a two-fold higher rate of cardiovascular death, stroke, and heart failure, the US Food and Drug Administration said.

Advertisement
The change is based on results of a clinical trial of the drug in patients with permanent atrial fibrillation that was halted early, in July, due to the increased risk of adverse events.

However, another clinical trial in patients with a different type of heart flutter, known as non-permanent atrial fibrillation, has shown the drug "provides a benefit," and may continue to be prescribed, the FDA said.

Since the FDA approved the drug in July 2009, 1.3 million prescriptions have been dispensed in the United States, US regulators said.

Source: AFP
Advertisement

Post your Comments

Comments should be on the topic and should not be abusive. The editorial team reserves the right to review and moderate the comments posted on the site.
* Your comment can be maximum of 2500 characters
Notify me when reply is posted
I agree to the terms and conditions

More News on:

Heart Healthy Heart Statins Mitral Valve Prolapse Aortic Valve Stenosis Pericarditis 
Advertisement

News A - Z

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

News Search

Medindia Newsletters

Subscribe to our Free Newsletters!

Terms & Conditions and Privacy Policy.

Advertisement

Advertisement
Advertisement

Stay Connected

  • Available on the Android Market
  • Available on the App Store

Facebook

News Category

News Archive