About Careers MedBlog Contact us
Medindia LOGIN REGISTER
Advertisement

US Regulators Wary of Sanofiís Multaq , Warn of Heart Risks

by Nancy Needhima on December 20, 2011 at 10:54 PM
Font : A-A+

US Regulators Wary of Sanofiís Multaq , Warn of Heart Risks

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.

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

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
What's New on Medindia
Test  Your Knowledge on Heart
Test Your Knowlege on Genes
Obesity in Teens Make Inroads into Early Atrial Fibrillation
View all
Recommended Reading
News Archive
Date
Category
Advertisement
News Category

Medindia Newsletters Subscribe to our Free Newsletters!
Terms & Conditions and Privacy Policy.

More News on:
Heart Healthy Heart Statins Mitral Valve Prolapse Aortic Valve Stenosis Pericarditis 

Most Popular on Medindia

Blood Donation - Recipients Nutam (400mg) (Piracetam) Drug Interaction Checker Pregnancy Confirmation Calculator Iron Intake Calculator How to Reduce School Bag Weight - Simple Tips Indian Medical Journals The Essence of Yoga Selfie Addiction Calculator Blood - Sugar Chart
This site uses cookies to deliver our services. By using our site, you acknowledge that you have read and understand our Cookie Policy, Privacy Policy, and our Terms of Use
×

US Regulators Wary of Sanofiís Multaq , Warn of Heart Risks Personalised Printable Document (PDF)

Please complete this form and we'll send you a personalised information that is requested

You may use this for your own reference or forward it to your friends.

Please use the information prudently. If you are not a medical doctor please remember to consult your healthcare provider as this information is not a substitute for professional advice.

Name *

Email Address *

Country *

Areas of Interests