LETTERS AND TESTIMONIALS

Posted on Tue, Nov. 30, 2004
Letters from readers on Amiodarone
Knight Ridder Newspapers
Some letters have been edited for length and clarity.

Thank you for your article which fully confirms my suspicions. I lost over two years to that drug and still suffer some of the consequences.
I would suggest you explore further as to why so many cardiologists prescribe this poison. It costs about $400 a re-fill. What were Wyeth sales doing to make it so popular?
Mary R. Hopkins, Philadelphia Inquirer Reader, Dec. 8, 2004
I read with interest your article today about Cordarone. A few years ago my cardiologist put me on it because of atrial fibrillation. Because of extreme sensitivity to a multitude of medicines, I take a rather dim view of most; consequently, my doctors tend to take a dim view of me. It didn't seem to bother me until I went to the hairdresser for a perm and when she shampooed it, my hair began coming out in her hands. No perm.
That was the beginning of my thyroid problems and the end of Cordarone in my life. I took myself off it, against doctor's advice.
As far as the FDA is concerned, I believe they are - as my brother-in-law used to put it about certain people - "handy if you don't need help."
Anyway, your article was informative - and I'm glad you are there.
Clara Stevenson, Woodstown, NJ, Dec. 8, 2004
My husband suffered from atrial fibulation for the last several years of his life. This was his only medical condition, and in fact had never even experienced heart failure. Sixteen months prior to his death, he was prescribed amiodarone despite having previously received a heart pacemaker to control his atrial fibulation. My oldest son researched this drug and tried desperately to have the cardiologist remove my husband from amiodarone. Even at this time, 1998, all information indicated this was a drug of last resort and not intended for long term use.  In spite of this, the doctor continued to prescribe amiodarone for him.  My husband died March 30, 1999 after having been on this drug for sixteen months.  He spent the last six weeks of his life living a very slow and painful death - slowly having the life suffocated out of him, unable to breath anymore.
How many hundreds, or thousands, more people must die from this terrible drug which has no apparent effect other than possible death.  The FDA is tragically failing to protect the American people.  Doctors are failing their patients, and many, many families are grieving the absolutely needless loss of their loved ones for the apparent greed of the drug manufacturers.
Ettal L. Brady, Brandon, FL, Dec. 3, 2004
I read you're latest article that recently ran in the Detroit Free Press. Once again you speak for many of us that share your thoughts. It means a great deal to the families that have needlessly lost a loved one that someone is able to continue to shed light to others while the government and drug companies procrastinate to say the least.
Not one more family should have to suffer like ours and so many others. Please continue to spread the word as you seem to be one of the only voices that is willing and able to do so.
David Austin, Farmington Hills, MI, Dec. 2, 2004
I'm writing to you because my husband died on September 12, 2003 from amiodarone toxicity. This was the principal diagnosis as noted by the physician on the death certificate. My daughter Paula Goward-Brylinski emailed you shortly after my husband died after locating an article authored by you on the internet in reference to this drug.
My husband did have a severe and long standing heart history which included 3 open heart bypass surgeries and the implant of a pacemaker/defibrillator. He took care of himself, consulted the doctor whenever he experienced symptoms and kept all scheduled appointments. When amiodarone was prescribed, we were NOT advised of the possible adverse effects of the drug. I am not attempting to lay blame on anyone, but would like to know that there will not be another death attributed to this drug. My husband suffered greatly and gradually continued to deteriorate after this drug was prescribed. According to his medical record, my husband was prescribed this drug to regulate his heartbeat so that the doctors could conduct the necessary testing of the defibrillator. At the time my husband was diagnosed with both atrial and ventricular fibrillation.
After months of this downward course, my husband was admitted to determine the cause and was diagnosed with interstitial pneumonitis. My husband was on amiodarone for approximately 5 months.
Needless to say, it was difficult seeing him suffer through this disease and to see him succumb to it. We miss him and our loss cannot be overstated. I am also going to report this to the government web site provided in this most recent article. Thank you for taking the time to research this drug and to read my account.
Mary Goward, Wixom, MI, Dec. 1, 2004
I just read your article on the very risky (in our case fatal) drug, amiodarone. Hopefully, this article will have positive results.
Doctors and patients have got to be educated on this drug. The FDA absolutely needs to act responsibly in preparing the advisory that would warn everyone of the many risks and fatal side effects of amiodarone. I honestly do not think my mother knew how serious the risks were, and she was a nurse for 40 some years. Thank you for taking this step.
Carol Holcomb, Flourtown, PA, Nov. 26, 2004
Thanks for your article on Amiodarone our family nearly lost our father to this medication in October. Our dad had heart bypass surgery on Sept. 21st of this year and as a normal course of action his doctors prescribed Amiodarone to be taken beginning 7 days prior to the surgery. After a successful surgery and recovery he was instructed to continue taking the drug for 10 days after returning home.
Within 4 days of coming home from the initial heart surgery he had to go back to the hospital due experiencing a severe shortness of breath. His condition rapidly deteriorated and he spent a full week in the ICU much of it on a ventilator battling extreme lung failure. Fortunately the lung damage was not permanent and he has recovered.
I am appalled that doctors are using this medicine as a normal course of the heart surgery routine, the doctors never even mentioned that there may be even minor side-effects let alone life threatening difficulties in taking this drug.
Chris Peterson, Des Moines, IA, Nov. 24, 2004
Thank you for the very informative article on the use or misuse of Amiodarone. In 2003 my mother was given the drug for atrial fibrillation after she had a pacemaker implant. I never understood why she then had problems with her lungs and vision.
Her death in September of 2003 was not a result of the drug as she had a fall but the drug certainly did make her life very difficult for about 6 months prior to her fall and resulting death. I hope that the FDA will now take measures to correct this off label use.
Judith L. Brand, Lee’s Summit, MO, Nov. 24, 2004
I read your excellent article which appeared in the Detroit Free Press on Friday 11/26 under the title, "Warning Stalled as Heart Pill Kills." It is a great service to the public. Thank you on behalf of all the people who may benefit from the information in it.
The problem of delay in warnings about the drug amiodarone is even more serious, however, than your article suggests.
Physicians, the manufacturer, and potentially the FDA have known or should have known about the severe (often fatal) side effects of this drug for at least 9 years.
Below is the short version of my husband's story….My husband Lawrence R. Van Til (who died in 2003 at age 61) had a congenital heart defect that was successfully operated on at National Institutes of Health in Bethesda, Md. in 1975. Severe atrial arrhythmia was a major effect of his condition…
After the surgery, he was relatively symptom free for 18 years … In 1993, after a severe fall on an icy sidewalk, the atrial arrhythmia returned. Soon amiodarone was prescribed by a local cardiologist…
In early 1995, he became very ill and was hospitalized for many weeks….
They attributed to the amiodarone severe liver damage, looming kidney damage and suspected lung damage.
He never recovered from the effects of the amiodarone and was never able to eat normally for the remainder of his life. It continued to be a life-threatening problem.
In addition to the severe liver damage (and looming effects of kidney damage), he eventually was diagnosed with one other effect of the amiodarone - severe polyneuropathy. His hands and feet had over many years become so painful that he could not lie in his bed at night, and no one else could successfully sleep in the same room. That side effect is apparently sufficiently well known that the physiatrist (specialist in physical medicine and rehabilitation) who diagnosed it informed us in July of 2000 that it is called "amiodarone polyneuropathy." It took this physician (who also is trained in internal medicine) less than an hour to get the complete medical history, examine my husband and confirm the diagnosis.
Through all of this, my husband continued to try to practice his profession and be as active as possible in the many community affairs in which he was engaged. He was a terrific person.
J. Kay Felt, Grosse Pointe Shores, MI, Nov. 28, 2004
As a pharmacist, I read with interest your article regarding "off-label" use of medications. The side effects of amiodarone are well-known, and it's difficult to even consider that patients apparently were not alerted to their possibility. I would like to share a few comments.
The FDA, having approved a drug, cannot physically police the prescribing habits of individual physicians. It's actions are largely limited by the data voluntarily provided to it by drug manufacturers, health care providers and consumers. Making unilateral decisions without irrefutable data to justify them would expose the FDA itself to litigation.
A manufacturer, having won FDA approval, has a vested interest in promoting the use of its drug to recoup its investment.
One approach to improve sales is to demonstrate the superiority of its drug in treating its approved indication. Another approach is to find new uses for the drug, either formally (research submitted to the FDA for scrutiny), or informally (which relies on off-label use by physicians). Although it may not legally promote off-label uses for its drug, a manufacturer has no real incentive or legal obligation to discourage it, either. The potential for a conflict of interest is obvious.
Physicians must necessarily bear primary responsibility for off-label use of drugs. His or her rationale may be based purely on anecdotal evidence, and/or upon scientific theory. Unfortunately, in the absence of objective evaluation, off-label drug use is prone to bias: benefits are inflated and/or side effects are minimized as physicians struggle to provide their patients with tangible results, and to avoid accusations that they 'didn't do enough'.
Nor may I excuse my own profession from doing more to protect the public. Many pharmacists are not aggressive in their role as patient-advocate, preferring a more subordinate role. To be fair, pharmacists typically learn of a particular drug choice/use after the physician has made his or her decision, and it is often extraordinarily difficult to assert a difference of opinion.
Nurses and other health care professionals face a similar dilemma.
Ultimately, a great deal of the 'blame' belongs to the American public. We have historically placed unquestioning trust in our health care professionals. However, medical science generally has not kept pace with our expectations, and this has lead to a growing cynicism. In the future, 'communication' must play a greater role in health care.
It is imperative that physicians involve their patients more in the decision-making process: "Mrs. Smith, although this medication isn't approved by the FDA for your condition, I would like to try it, and these are the reasons why I think it will work where other drugs didn't/wouldn't.... these are the risks associated with the drug, and this is what WE are going to do to prevent/address them..." The patient can thus make an 'informed decision' (and the physician will want to document this).
Patients and their families must ask more questions and become better informed; pharmacists, by virtue of their training and availability, are a valuable resource. Healthcare professionals in general must take a more aggressive role as patient-advocate, ensuring their clients understand and accept the risks as well as benefits of treatment.
Finally, objective evaluation of off-label medication use must occur, a goal which may require a more intrusive role for the FDA, and/or an outright ban. This matter might require a public referendum.
Again, thank you for your recent coverage of 'off-label' medication use and your efforts to raise consumer awareness. While it may ruffle a few feathers, I firmly believe America ultimately benefits from having a better-informed consumer, and will make our health care system the best in the world.
Mark Laus, Pharm.D., R.Ph., (Doctor of Pharmacy, Registered Pharmacist)
Grosse Pointe Woods, MI, Nov 27, 2004
Nice article!
I take Amiodarone, and was THOROUGHLY advised as to its dangers. I've had it about five years.
Arrhythmia is like slow death for me -- no energy: I can't walk or climb stairs and therefore lose all my muscle tone and any cardiovascular fitness I might have had.
I went 'off' it (out of fear of side effects) and was out of rhythm in a week: all I could do was sit in a chair and suck oxygen.
Eight months later I started taking it again and feel great.
For me, that's the right tradeoff.  I do NOT want to be one of those gray, scared-looking folks in the Cardiologist's office!
Lane Trubey, Sao Miguel, Azores, Nov. 26, 2004
Thank you for your recent article on this deadly drug that has affected so many lives. Your article validated what we felt we already knew.
My 82 year-old mother is a survivor of amiodarone, but the effects have been devastating. Thanks to her tenacity (she visited one doctor after another in 1997/98 until finally a terrific doctor diagnosed her condition and immediately removed Cordarone from her diet. In his words, he said she was not intoxicated by the medicine, but was poisoned from it. We now know he saved her life.)
Maria Lopez, Miami Springs, FL
I was surprised by your fine article. I have taken amiodarone for the last ten years. It was first subscribed for me by the Singapore Doctor who treated the Sultan of Burnei. We were working and living in Singapore. I have atrial flutter. Within a couple weeks, the heart was beating regularly all the time. As soon as it stabilized, he reduced the dosage until we got it down to 400 mg a whole week (a half tablet daily and one day a week with none). I am totally unaware of any side effects from this low dose and expect to take it the rest of my life. I first learned about its toxicity from the 1998 edition of the British Medical Association New Guide to Medicines and Drugs. Eight years is a long time for the FDA to get around to dealing with the common over-dosing of this drug!
Charles Darso, Joplin, MO, Nov. 28, 2004
My family has known for years what this drug can do to a person. Unfortunately, it was good to see that now there are others coming forward about this drug.
My father was given amiodarone in the early 90's when it had not been approved by the FDA. He had atrial fibrillation and was given the drug after other things did not help. He developed lung problems and spent one summer in the hospital due to this. He had problems with his vision and went to many doctors. The doctors could not figure out what was wrong with his eyes.
Now we know...amiodarone!
His health continued to deteriorate after being taken off the medication with continued lung problems, thyroid surgery, aneurysm surgery and finally his death in 1996. The death report states that he had a brain aneurysm due to coumadin, but by this time (two years later), the damage had been done. Before taking amiodarone, he was able to do just about what he wanted and was an active man to be in his 70's. After taking the drug, he wasn't able to do much of anything and his quality of life was poor.
It was sad to see him suffer like he did.
Anita Huffman, Kansas City Star reader, Nov. 24, 2004


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