Recent Amiodarone News & Information

In 2005, the FDA issued a safety alert warning patients and medical professionals that amiodarone may cause side effects like pulmonary toxicity, hepatic injury and worsened arrhythmia.

If you believe you have been adversely affected by amiodarone side effects like blindness, TEN, lung damage or kidney failure, contact a knowledgeable amiodarone attorney today to discuss your legal options. You may have grounds to file an amiodarone lawsuit against the drug manufacturing company, in order to seek fair and timely reimbursement for your losses.

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Amiodarone is part of a group of medicines known as antiarrhythmics and is used to treat life-threatening heart rhythm problems known as ventricular arrhythmias. Amiodarone is used on patients that have received treatment with other drugs that did not work well on their condition. This medicine works right on a patient’s heart tissue and slows down nerve impulses in the heart. It is used to keep your heart beating regularly.

Amiodarone can only be used under a doctor’s prescription and is available in tablet form. Before deciding to take this medicine, you should understand the risks involved and be able to weigh the risks against what the medicine can do for you.

What is Amiodarone Used For?

Amiodarone treats heart rhythm problems such as atrial fibrillation, an irregular or rapid heartbeat which leads to reduced blood flow and heart arrhythmias. It received FDA (U.S. Food and Drug Administration) in 1985 and is marketed by Upsher-Smith Labs under the name Pacerone. Wyeth-Ayerst Labs sell it under the name Cordarone.

Amiodarone belongs to the Class III out of four major classes of anti-arrhythmic drugs, and its function is to decrease the electrical activity in the heart, increase activity time for the hearts contractions, block receptors using adrenaline, and prevent or slow the passing of sodium out of your heart’s cells.

How to Use Amiodarone

There is a medication guide enclosed with a prescription of amiodarone that you should read and follow. If you are unsure about any of the information provided, you should ask your pharmacist or doctor to explain what it means.

The medication is to be taken by mouth, usually once or twice a day as directed by your doctor. You are allowed to take this medication with or without food, but it is important to follow the same pattern throughout your prescription.

You are required to give up eating grapefruit or drinking grapefruit juice while taking amiodarone unless your doctor prescribes otherwise. Grapefruit has the ability to increase the amount of this medicine in your bloodstream.

The dosage of amiodarone you take may be adjusted by your doctor depending on your response to the medicine and your medical condition. Always follow your doctor’s directions on how to take this medication and do not stop taking it unless directed by your doctor to do so. Keep your doctor aware of any health changes you experience once you have begun the treatment.

How Effective is Amiodarone?

Amiodarone is the most effective medication for controlling atrial fibrillation. It is especially effective in a broad range of patients with reduced left ventricular ejection fraction. It has shown adverse side effects when taken long term including some that are irreversible. The side effects tend to be dose-dependent with lower dosages being a much safer treatment. It should be noted that no published experiences are verifying that lower doses are less harmful.

The medication must be taken regularly from one to three weeks before a response can be registered and for several months before your doctor can verify its full effects.

Names Used for Amiodarone

Amiodarone was meant as a last resort medicine; however, it is widely prescribed by its manufacturers and promoted as a first choice anti-arrhythmic drug and is frequently prescribed in the U.S. There are three names it can be found under:

  • Cordarone
  • Pacerone
  • Amiodarone

Allergies Connected to Amiodarone

Just as with any medicine you take, if you notice any unusual or allergic reactions to the drug, you should alert your doctor immediately. Your doctor should be aware of any allergies you suffer from preservatives, foods, dyes, or animals before accepting this drug.

Age and Condition Concerns Regarding Amiodarone

  • Pediatrics

There have not been any relevant studies conducted on the relationship between age and the effects of amiodarone. There has not been efficacy or safety established by the administering of amiodarone to the young.

  • Elderly

There have been no relevant studies performed that would show geriatric-specific problems by administering amiodarone to the elderly. The elderly are; however, more likely to suffer from age-related heart, liver, or kidney problems. These conditions may require an adjustment in the dose and caution when prescribing this medicine to the elderly.

  • Breastfeeding

There have been no appropriate studies performed on women breastfeeding to determine if their child would be at risk if they take the medicine amiodarone. If you are breastfeeding your child, you should weigh all benefits against the risks before taking this medicine.

Dangerous Drug Interactions with Amiodarone

Certain medications should not be used together for any reason; in other situations, two drugs can be used together even if there is an interaction. Your doctor may have to adjust the dosage of your medications or take other precautions if you are taking certain drugs when prescribing amiodarone. This danger makes it crucial for you to advise your physician if you are taking any of the following medications should amiodarone ever be prescribed for you:

  • Bepridil
  • Colchicine
  • Fingolimod
  • Grepafloxacin
  • Ketoconazole
  • Mesoridazine
  • Pimozide
  • Posaconazole
  • Saquinavir
  • Terfenadine
  • Tipranavir
  • Ziprasidone
  • Amisulpride
  • Cisapride
  • Dronedarone
  • Fluconazole
  • Indinavir
  • Levomethadyl
  • Nelfinavir
  • Piperaquine
  • Ritonavir
  • Sparfloxacin
  • Thioridazine
  • Vernakalant

This list contains the drugs that should not be in combination with amiodarone. There is another list of medications you may use together with amiodarone so you must advise your doctor of all drugs you are taking so it can be verified by this list whether or not they are compatible with amiodarone.

Interactions with Foods and Amiodarone

There are certain foods you must refrain from when taking specific medications. Eating specific foods or eating any form of food when taking specific medications may cause negative interactions. The use of tobacco or alcohol may also cause adverse reactions to certain types of medicines. Talk with your doctor concerning any negative reactions which could occur if you are using tobacco products or consuming alcohol when amiodarone is prescribed. You should not eat grapefruit or drink its juice if you have been prescribed amiodarone, and you should discuss whether there is a time limit between taking the medication and meal times with your doctor.

Medical Conditions that Affect the Use of Amiodarone

Certain medical conditions may cause adverse responses from amiodarone. If you suffer from any health conditions, you must make sure your physician knows of them if amiodarone is prescribed:

  • Bradycardia or slow heartbeat
  • Sick sinus syndrome or an abnormal heart rhythm but are not treating it with a pacemaker- amiodarone is not recommended for patients with this condition
  • Heart disease such as congestive heart failure
  • Hypokalemia or low potassium in your blood
  • Hypotension or low blood pressure
  • Thyroid problems- amiodarone is not recommended for patient’s with these problems as the medicine may worsen your condition
  • AV block or abnormal heart rhythm
  • Cardiogenic shock
  • Vision or eye conditions
  • Heart problems such as QT prolongation
  • Hypomagnesemia or low magnesium in the blood
  • Lung disease or other breathing problems

Side Effects from Amiodarone

People who take the anti-arrhythmic drug Amiodarone, Pacerone or Cordarone are at risk of devasting side effects. Patients who have suffered any of the numerous side effects state they would not have used this medication had they been warned of possible side effects. You must remember, your doctor has prescribed this medicine as they feel that it will be a benefit to your condition, if you suffer any of these side effects, you must discuss them with your doctor immediately.

  • Pulmonary Toxicity

Pulmonary toxicity can be a severe and sometimes fatal side effect of taking the medication, amiodarone. It has been known to damage the lungs and your ability to get oxygen. APT (Amiodarone Pulmonary Toxicity) may cause fluid to develop in your chest wall and lungs. This build-up of the fluid reduces your intake of air and decreases your ability to breath normally. When you do not receive proper air flow through breathing, your lungs cannot oxygenate your bloodstream.

Amiodarone Pulmonary Toxicity can affect those suffering from pre-existing lung conditions before beginning treatment as well as those with no history of lung complications. It has been seen to affect men more than women, though devasting effects are the same for either gender.

Research is showing that APT is more prevalently seen in patients who are on the higher doses; however, it can and does occur in patients taking as low as 200 mg per day.

If you begin suffering any form of these side effects after starting an amiodarone treatment, you need to contact your doctor immediately:

  • Coughing up blood
  • Fever
  • Unexplained weight loss
  • Chest pain aggravated by breathing
  • Dry cough
  • Shortness of breath

Amiodarone takes a long time to leave your system. If you should develop APT, your doctor will have to discontinue this treatment and place you on a corticosteroid therapy that you will need to continue until the amiodarone is entirely out of your system. If detected early, you will have a better prognosis than if you go into respiratory distress. Those who allow the condition to advance to the respiratory distress level have a much higher risk of dying.

  • Thyroid Problems

Amiodarone can cause thyroid problems. The thyroid, also known as the butterfly-shaped gland in your neck is responsible for regulating your metabolism along with other body processes. While it is rare, it can either cause a low thyroid function or overactive function.

There is a high iodine content in amiodarone which can deliver more than a hundred times the daily allowance to your body. This iodine level can damage your thyroid gland putting you at risk to develop AIH (Amiodarone Induced Hypothyroidism) or AIT (Amiodarone-Induced Thyrotoxicosis) while you are undergoing treatment or even months after you stopped taking the medication.

You should talk with your doctor immediately if you show signs any of these signs affecting your thyroid:

  • Brain fog
  • Difficulty concentrating
  • Fatigue
  • Heart failure
  • Joint pain or stiffness
  • Lethargy
  • A hoarse or deep voice
  • Muscle weakness and pain
  • Fast heart rate
  • Tremor
  • Irregular heart rate
  • Cold sensitivity
  • Dry skin
  • Goiter

There are two different types of AIT:

  • Type 1 is an induced hyperthyroid condition which may be followed by hypothyroidism. This disorder can resolve in time, or it will remain hypothyroid, and you will be required to have a prescription for thyroid hormones the rest of your life.
  • Type 2 is a more severe form and destroys the thyroid tissue causing inflammation and fibrosis which can, in turn, damage your gland and cause a flood hormone to be released. This condition can lead to cardiac issues such as atrial fibrillation.
  • Skin Conditions

Amiodarone has been known to make the skin more sensitive to the sun. When using this medication as a long-term treatment, you could develop a blue-gray color to your skin. The condition is not harmful, and a healthy skin color may return after you’ve stopped taking amiodarone. To help prevent this from occurring, you should limit your time in the sun and avoid sunlamps and tanning booths. You should always use sunscreen and wear protective clothing when exposed to sunlight, and tell your physician immediately if you are sunburned or notice sun blisters or redness.

  • Vision Changes

Amiodarone has been known to cause vision changes. Cases are not common for this change; however, you should contact your doctor immediately if you notice any change in your eyes after starting this medication. Those who have suffered vision changes report their vision blurring and some have experienced seeing halos.

Research shows that amiodarone can cause optic nerve damage and permanently blind you. Most people who use this medication will develop corneal microdeposits which can interfere with your vision and inflame the optic nerve which damages it.

Common eye-related side effects of this medicine include:

  • Eye pain
  • Loss of eyebrows or eyelashes
  • Blurred vision
  • Eye sensitivity to sunlight
  • Seeing halos

There are also side effects which result from how amiodarone interacts with your body’s processes including:

  • Swelling or papilledema of the optic disc as a result of an increase in intracranial pressure
  • Optic neuropathy or the gradual death of the fibers of your optic nerve
  • Macular degeneration of the central portion of the retina which leads to severe vision loss
  • Scotoma or blind spots in your field of vision

You need to consult with your doctor immediately if you experience any of these conditions.

  • Liver Damage

Amiodarone can cause you to develop liver damage, cirrhosis, and pseudo-alcoholic. This medication is fat soluble and remains in the liver causing damage to the organ for months after you have stopped treatments.

The drug and its metabolites gather in the liver and inhibit normal liver functions which causes inflammation. When the tissues become damaged and scarred in your liver, necrosis occurs which is known as AIC (Amiodarone Induced Cirrhosis).

Like cirrhosis, AIC causes irreversible liver damage as the liver begins to lose functionality. When the liver starts to fail, other organs in the body will also begin to falter. AIC can cause acute liver failure, excessive bleeding, increased pressure on the brain, renal failure, a buildup of toxins in your body, and death.

There are no early warning symptoms of AIC; however, you may experience some of these side effects:

  • Changes in your personality
  • Dark urine
  • Itchy skin
  • The upper right part of your abdomen becoming painful
  • Swelling of your abdomen, legs, and ankles as fluids begin to build up in your body
  • Yellowing of the whites of your eyes
  • Bloody stools
  • Confusion
  • Fever
  • Loss of appetite and nausea
  • Severe fatigue
  • Vomiting
  • Yellowing of your skin
  • Allergic Reactions

Allergic reactions have been reported in patients who have taken amiodarone. There are not many cases, but some patients have reported developing an itching, rash, swelling of the throat, tongue, face, severe dizziness and trouble with their breathing.

  • Other Side Effects

Patients taking the medication amiodarone have an increased risk of devasting side effects. Some of these side effects include blindness, lung disease, pulmonary fibrosis, and a severe skin disease known as TEN (Toxic Epidermal Necrolysis).

Studies of this medication have reported that more than 15 percent of patients who take amiodarone as a treatment for ventricular arrhythmias have developed severe lung damage with 10 percent of them dying.

Studies Performed on Amiodarone

There are two black-box warnings concerning the possible risk of amiodarone causing sudden death and other side effects that threaten a patient's life. Other possible threats include an irregular heartbeat, inflammation of the lungs, liver inflammation or damage. The FDA issued a safety alert in 2005 warning patients and those in the medical community about possible side effects including worsened arrhythmia, hepatic injury, and pulmonary toxicity. The warning included a statement telling the medical community; amiodarone should only be used as a treatment for adults with life-threatening ventricular arrhythmias. It further said this treatment should only be used when all other alternatives failed.

What Your Doctor Needs to Know When Prescribing Amiodarone

If your doctor has prescribed amiodarone as a treatment plan for you, it is essential you alert them if you are allergic to iodine or have any form of allergies. There are active ingredients in amiodarone which may cause allergic reactions. You must also inform them if you have any history of liver disease, thyroid problems, or lung disease as this medicine could worsen your condition.

Taking amiodarone can make you dizzy; therefore, you should not drive or operate machinery or perform any form of activity where you must remain alert until you understand the effects this medicine will have on you.

Amiodarone can cause a condition known as QT prolongation. This condition is rarely fatal but can cause serious irregular or fast heartbeat and other symptoms that will require medical attention immediately. The risk of QT prolongation is even greater if you have certain medical conditions or are taking drugs which could cause QT prolongation. This threat is the reason it is imperative you speak with your doctor about all medical history and list of medications you are taking before beginning an amiodarone treatment plan.

If you have low levels of magnesium or potassium in your blood, it may increase your risk of QT prolongation. The use of water pills or diuretics can also increase the threat of QT prolongation. Other health factors that could increase your risk of developing QT prolongation are having conditions such as severe sweating, vomiting, or diarrhea. Talking with your doctor about all health concerns is vital to ensure you use amiodarone safely.

Any woman planning on becoming pregnant or who is already pregnant should tell their doctor before beginning an amiodarone treatment plan. The medication may not be safe for your unborn child. This medication can also pass through your breastmilk and have adverse effects on your child, so speak with your doctor if he prescribes amiodarone and you are breastfeeding your infant.

Legal Help for Those Suffering Side Effects

Lawsuits have been filed against Wyeth Pharmaceuticals and Par Pharmaceutical on behalf of families and individuals who have suffered death or injury after being on an amiodarone treatment plan.

It is believed the drug makers breached their legal duty to protect the lives of patients who depended on these medications, as they negligently marketed the drugs for off-label use.

Patients who have suffered from liver damage, thyroid damage, pulmonary toxicity, vision loss or any other side effect from this medication that has altered their quality of life should seek legal advice on what their rights are for compensation.

Often with medications that have affected the lives of numerous patients, a Mass Tort is filed as a civil action. A Mass Tort allows numerous plaintiffs to file against a few defendants to seek compensation in court. Those suffering severe side effects from a prescribed medication should seek legal counsel and inquire if an existing Mass Tort is in place for amiodarone and how to become a part of the settlement.

Find Help Filing an Amiodarone Lawsuit Near Me

If you or someone you care about has been put on an amiodarone treatment and is now suffering from severe side effects, you may be able to file a prescription medication litigation. If you need more information concerning such lawsuits or legal help when you file one, call Consumer Alert Now 800-511-0747. Let us help you connect with a premier firm who understands how to help you through this challenging legal situation.