StopAfib.org Applauds the FDA for Providing a Safer Option for Those with Atrial Fibrillation (AF) and Atrial Flutter
July 30, 2009 5:43 AM CT
Contact: Mellanie True Hills at www.StopAfib.org or 940-466-9898
Dallas, TX—On behalf of the atrial fibrillation patient community, StopAfib.org applauds the U.S. Food and Drug Administration (FDA) for approving Multaq® (dronedarone) and providing a safer option for those with atrial fibrillation (AF) and atrial flutter (AFL).
Amiodarone is considered the most effective anti-arrhythmic drug for most atrial fibrillation patients, but many patients refuse it because of the serious side effects. While Multaq® is slightly less effective than amiodarone, it is far safer. The ATHENA trial showed that Multaq® reduced hospitalization and death for patients with paroxysmal atrial fibrillation, persistent atrial fibrillation, or atrial flutter.
At recent hearings of the FDA Cardiovascular and Renal Drugs Advisory Committee, the atrial fibrillation patient community asked the FDA to provide safer atrial fibrillation treatment options by approving this alternative to amiodarone. Giving voice to the afib community at the hearing was atrial fibrillation survivor and StopAfib.org CEO and founder, Mellanie True Hills, who said, “Living with atrial fibrillation is physically exhausting and emotionally draining, not just for you, but for your family, too. And atrial fibrillation takes a financial toll—huge medical bills, trouble getting insurance with afib, lost time from work, and for some even losing jobs or careers. Afib can be financially devastating.”
Hills also shared amiodarone experiences from the afib patient community. For some, amiodarone worked great; for others, there were minor issues; and for the vast majority, amiodarone caused serious issues, such as thyroid damage, liver problems, kidney problems/failure, lung and breathing problems, respiratory distress, vision problems, diaphragm paralysis, nervous system damage, severe hair loss, speech loss, cognitive problems that led to job loss, and death.
One afib patient who developed amiodarone-induced thyroiditis said, “I consider myself lucky that it only attacked my thyroid, and not my lungs or liver. I would risk losing my life to be afib-free because I am an invalid in afib. The only drug that guarantees sinus rhythm will kill me. I live every day with a crippling fear of afib so I plead to you to please allow this drug into the U.S.”
On behalf of the afib patient community, Hills asked the FDA Advisory Committee to “please give us options, please give us solutions, and please give us our lives back.”
For more, see entire text ofHills’ remarks on behalf of the afib community to the FDA Advisory Committee
The FDA recently approved Multaq®, except in cases of severe heart failure. Afib patients have anxiously awaited it, and now that it is available, are very excited and wish to thank the FDA for providing this safer option, the first new anti-arrhythmic drug for afib in many years.
Once Multaq® was available, one patient summed up the sentiment of many by saying, “I have no idea if or what insurance will pay, but I will get it, even if I have to pay it all myself.”
About Atrial Fibrillation
Atrial fibrillation (afib), the most common irregular heartbeat, is a misfiring of the electrical signals of the heart involving a rapid heart rate and irregular heartbeats or a quivering of the upper chambers of the heart. Often considered benign, with its skipped heartbeats, heart palpitations, and fatigue, it can in fact lead to congestive heart failure or to stroke.
One-third of atrial fibrillation patients will have a stroke, and afib is responsible for over 100,000 strokes every year in the United States. Stroke, the #3 killer, takes at least one person every hour of every day and is the #1 cause of permanent disability among women and men. StopAfib.org has designated September as Atrial Fibrillation Month to raise awareness of this life-threatening irregular heartbeat.
StopAfib.org—for patients by patients—and the companion Atrial Fibrillation Blog are focused on improving the quality of life for patients and their families, supporting the doctor-patient relationship, and decreasing afib-related strokes.
These sites provide information about atrial fibrillation symptoms, causes, risks, and treatments, and include news, videos, discussions, resources, and a newsletter with the latest in atrial fibrillation. The Atrial Fibrillation Services Locator is one of the site’s most popular destinations. Now the #1 U.S. Arrhythmia site on the Internet and in the Top Heart Disease sites, StopAfib.org has received the HON Code Certification from the Health on the Net Foundation, signifying a site that provides credible and trustworthy health and medical information. The goal of StopAfib.org is to be one of the most trusted communities for atrial fibrillation patients.
For more information, visit www.StopAfib.org or contact Mellanie True Hills at 940-466-9898