Speaks on Behalf of the Atrial Fibrillation Community at FDA Hearing Speaks on Behalf of the Atrial Fibrillation Community at FDA Hearing

July 2, 2009 5:21 AM CT

UPDATED 7/2/2009: See: FDA Approves Multaq® for Patients with Atrial Fibrillation or Atrial Flutter

On March 18, 2009, shared stories from atrial fibrillation patients at the FDA Cardiovascular and Renal Drugs Advisory Committee hearings regarding a replacement for amiodarone. We greatly appreciate you sharing your many stories with us, both good and bad, and sharing them right up until I spoke.

When I first heard a few weeks ago about the hearing and that comments from the public were requested, I considered representing the views of the atrial fibrillation community. I didn’t have an opinion myself as I’d never taken amiodarone, but I trusted my gut that there was a message that needed to be shared even though I wasn’t sure exactly what. I went into this without any preconceived notion, simply wanting to represent the experiences of the afib community.

I asked for your input and you didn’t disappoint. Thank you for sharing your stories with us. Many of you shared how amiodarone was working just great. Others had minor issues—some issues you could live with, and others you couldn’t. The vast majority of you that responded, however, had major issues with amiodarone, and many of you were awaiting dronedarone (Multaq), the amiodarone-replacement being reviewed by the FDA.

So I shared your input and stories with the FDA—you will find the transcript of my comments below, but first here is a summary of the meeting.

Meeting Summary — FDA Advisory Committee on Cardiovascular and Renal Drugs 3/18/09

The morning consisted primarily of presentations and recommendations by the company that makes dronedarone and by the FDA.

After a lunch break, representatives of three organizations—the American Medical Directors Association, the National Stroke Association, and—spoke.

The rest of the afternoon consisted mostly of questions and discussions about the data and clinical trial processes and got into details that only clinical investigators would understand or care about.

But there were a couple of interesting shifts away from the data and process discussions, such as when Dr. Henry Black (New York University School of Medicine) shifted the discussion towards patients by saying that he was open to prescribing dronedarone for his afib patients. Subsequently, Dr. Sanjay Kaul (Cedars-Sinai Heart Institute) pressed for dronedarone to be considered only for those having problems with amiodarone, but Dr. Robert Temple (director, FDA Office of Medical Policy) shot back, “Amiodarone is fantastic at preventing atrial fibrillation. It’s just not very good at preventing death.” He admitted to having atrial fibrillation, but said that he would not go on amiodarone long term.

When it was time to vote, the committee members voted simultaneously, and that was then followed by a roll call vote in which each stated his comments and recommendations for the FDA to consider in the approval process. The final vote was 10-3 in favor of recommending to the FDA that dronedarone (Multaq) be approved for treatment of atrial fibrillation, with some limitations.

Transcript of Comments to the FDA Advisory Committee on Cardiovascular and Renal Drugs

Presented by Mellanie True Hills, CEO of, on March 18, 2009

I am Mellanie True Hills, CEO of the American Foundation for Women’s Health and its’ atrial fibrillation patient advocacy site. Sanofi-aventis is one of a number of sponsors, but they are not paying for me to be here today.

I’d like to thank the committee for the opportunity to speak today on behalf of thousands, maybe even millions, of members of the atrial fibrillation community.

I am an atrial fibrillation survivor. In 2003, my heart skipped some beats, and started racing. I got dizzy. My right leg went cold, and my right eye went fuzzy. I had blood clots and a near-stroke from atrial fibrillation.

Episodes started coming frequently. Once you’ve had blood clots, afib becomes frightening. Would I be off by myself and have a stroke? My family wouldn’t let me go anywhere by myself.

Afib is physically exhausting and emotionally draining, not just for you, but for your family, too. And it takes a financial toll—huge medical bills, trouble getting insurance once you have afib, lost time from work, and for some even losing jobs or careers. Afib can be financially devastating, but we don’t talk about it because we’re too embarrassed.

Since I was never stable on Coumadin for genetic reasons, I was a stroke walking around waiting to happen. I had a surgical procedure in 2005 that cured my afib and gave me back my life and freedom. I have been afib-free for 3 1/2 years. I am thankful for it every day.

After being cured, I couldn’t stand on the sidelines and watch others suffer, so I created a web site,, for anyone with afib. It provides information and answers. We’re the #1 US Arrhythmia site.

Every week, I talk with hundreds of afibbers, and many say, “My doctor insists that I go on amiodarone, but I’m scared of the side effects.”

I realized that someone needed to speak on behalf of the afib community, so that’s why I’m here today. I reached out to them for their experiences with amiodarone—good and bad—with no indication as to why I was asking. Responses flooded in.

Some said that they had just started on amiodarone and it was working fine. Others had been on it for several years, and it worked great for them.

For others, it didn’t work, or had stopped working. For some, it made the afib worse.

Some had side effects that were bothersome, such as nausea, vomiting, dizziness, aversion to food, aches and pains, rash, sun sensitivity, decreased energy, and flu-like symptoms. Some considered these worth living with, others decided to stop amiodarone and their symptoms reversed. One said, “I only realized how badly it made me feel after I stopped amiodarone.” 

Most, however, had serious side effects, such as:

  • Thyroid damage, liver problems, kidney problems and potential failure, lung and breathing problems or respiratory distress, vision problems such as halos and delaminated corneas, skin discoloration, severe hair loss to the point that they needed to wear a wig, and cognitive problems and speech loss that caused several to lose their jobs
  • Most had multiple problems, and many were so miserable from amiodarone that they couldn’t function
  • Doctors believe that amiodarone paralyzed one patient’s diaphragm
  • In another, amiodarone fried her nervous system—still today, she shakes endlessly and can’t sleep
  • An artist can no longer paint due to her blurred vision and trembling hands
  • One retired doctor had flu-like symptoms and died from amiodarone-induced pulmonary toxicity

Most surprising to me were the responses that came in saying, “We’re anxiously awaiting dronedarone—what’s taking the FDA so long?” One retired doctor said, “My wife and I may go to Europe to get it if we have to as she is having so much trouble with amiodarone.” Another said, dronedarone is my last hope before considering surgical procedures.

I hadn’t even told them why I was asking as I didn’t want any bias. But believe me, the atrial fibrillation community is far from unbiased over this. After so many such comments, I asked for more input to share with you today, and was stunned by the responses. Here is what one woman asked me to share—she said:

I developed afib in 2002. I already had hypertrophic cardiomyopathy, severe to moderate mitral regurgitation, and my left atrium was enlarged. I couldn’t tolerate afib. I was put on amiodarone and given an ICD/pacemaker. I took amiodarone for almost three years and the results were miraculous.

But then I developed amiodarone-induced thyroiditis. Surgery to remove the thyroid was deemed too risky with my heart condition so I spent a year off of amiodarone though my endocrinologist wanted to radiate and destroy it. I got my thyroid back to normal, but I suffered from afib as the amiodarone wore off.

Two years ago, I had open heart surgery with a maze procedure and was afib-free for a year, but then it came back. I was faced with destroying my thyroid and going back on amiodarone, the only drug I can tolerate. I consider myself lucky that it only attacked my thyroid and not my lungs or liver, but I would risk losing my life to be afib-free.

I am counting the days until I can take dronedarone, and will travel abroad to get it if I have to. I am an invalid in afib. The only drug that guarantees sinus rhythm will kill me, but someday I will have no choice unless dronedarone is made available. I live every day with a crippling fear of afib so I pray and plead—please allow this drug into the U.S.

So, the afib community is asking you, “Won’t you please give us options, please give us solutions, please give us our lives back.” Thank you.

More information

Check out these reports from the meeting:

Briefing materials from the FDA and Sanofi-Aventis