ClotCare: Blood Clots, Stroke, Heart Attack
Monday, October 7, 2024
Home   |   DVT/PE   |   Blood Clots   |   Coumadin/Warfarin   |   New Patients   |   Self Testing   |   Email List   |   Donate

Pick a Topic:

Find info on a:

We subscribe to the HONcode principles of the HON Foundation. Click to verify.
ClotCare complies with the HONcode standard for trustworthy health
information:
verify here.

ClotCare is a member of the Coalition to Prevent Deep Vein Thrombosis (DVT Coalition)  ClotCare is a member organization of the Coalition to Prevent Deep Vein Thrombosis. Click here to learn more about the Coalition to Prevent Deep Vein Thrombosis and DVT Awareness Month, which is held each March.

FDA Approves Multaq to Treat Heart Rhythm Disorder

FDA NEWS RELEASE
For Immediate Release: July 2, 2009
Contact: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov

The U.S. Food and Drug Administration has approved Multaq tablets (dronedarone) to help maintain normal heart rhythms in patients with a history of atrial fibrillation or atrial flutter (heart rhythm disorders). The drug is approved to be used in patients whose hearts have returned to normal rhythm or who will undergo drug or electric-shock treatment to restore a normal heart beat.

Multaq may cause critical adverse reactions, including death, in patients with recent severe heart failure. The drug's label will contain a boxed warning, the FDA’s strongest warning, cautioning that the drug should not be used in severe heart failure patients.

"Multaq represents a therapeutic innovation for treatment of the heart rhythm disorder of atrial fibrillation," said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research.

In a multinational clinical trial with more than 4,600 patients, Multaq reduced cardiovascular hospitalization or death from any cause by 24 percent, when compared with an inactive pill (placebo). Most of that effect represents reduced hospitalizations, especially hospitalizations related to atrial fibrillation. Atrial fibrillation and atrial flutter cause the heart to beat abnormally fast and sometimes prevent blood from being properly pumped out of the heart.

The most common adverse reactions reported by patients in clinical trials were diarrhea, nausea, vomiting, fatigue and loss of strength.

Multaq is manufactured by Paris-based sanofi-aventis.

Ask a question about blood clots or anticoagulant medications Have questions? Ask ClotCare. Send questions by email to webmaster@clotcare.org.

ClotCare is a 501(c)(3) non-profit organization generously supported by your tax-deductible donations and grants from our industry supporters.

Blood Clot Activities Calendar

New Postings:

Click here to view full list of new postings
ClotCare Home | New Postings | Patient Postings | Clinician Postings | Join Our Email List | Useful Web Links
CE Opportunities | Training Programs | DVT & PE Stories | Editorial Board | Financial Support
About ClotCare | DVT Coalition | Donate to ClotCare | Contact Us
Key topics discussed on ClotCare include: Blood Clots | Deep Vein Thrombosis (DVT) | Pulmonary Embolism (PE) | Atrial Fibrillation (A. Fib or AF) | Heart Attack | Stroke | Transient Ischemic Attack (TIA) | Mini Stroke | Bleeding Complications | Vascular Surgery | Surgical Blood Clot Removal | Warfarin | Coumadin | Lovenox | Low Molecular Weight Heparin (LMWH) | Heparin | Anticoagulants | Plavix | Aspirin | Antiplatelets | Blood Thinners
Copyright 2000-2018 by ClotCare. All rights reserved.
Terms, Conditions, & Privacy | Image Copyright Information
19260 Stone Oak Parkway, Suite 101 | San Antonio, TX 78258 | 210-860-0487
Send comments to webmaster@clotcare.org.
Monday, October 7, 2024