Amiodarone used for atrial fibrillation has been associated with a number of serious and even life-threatening side effects. Because of these risks, the U.S. Food and Drug Administration (FDA) has never approved amiodarone as a first-line treatment, instead stating it should be prescribed only after the patient has failed to respond to other treatments and the physician has determined that its benefits outweigh the risks.

Unfortunately, some doctors have prescribed it before trying patients on other drugs, allegedly at the behest of drug companies who have supposedly been misleading them about the dangers of amiodarone.

What is Amiodarone?

Sold under brand names that include Cordarone, Nexterone and others, amiodarone is indicated for a range of heart conditions known as arrhythmias, or irregular heartbeart, such as:

• atrial fibrillation (AT, or “a-fib”)
• paraoxymal supraventricular tachycardia (PVST)
• ventricular fibrillation (VF)
• ventricular tachycardia (VT)
• wide complex tachycardia

 Originally introduced in 1962 for the treatment of angina pectoris (general chest pain due to insufficient blood flow to the heart), it was pulled from the market six years later because of its side effects. However, in 1974, the drug was reintroduced after it was found to be effective for treating arrhythmia. Amiodarone’s mechanism of action delays the period between contractions of the heart muscle.

Everyday Health explains that amiodarone first received FDA approval in 1985 under the brand-name Pacerone. The drug was manufactured first by Wyeth Pharmaceuticals, which was acquired by Pfizer. Now, it is available both in its brand-name form and its generic form.

What are the Side Effects of Amiodarone?

Common and relatively minor side effects are:

• generalized fatigue
• tremors
• nausea
• constipation

Serious side effects include:

• lung disease (fibrosis and interstitial pneumonitis, or inflammation of lung tissue)
• liver damage (jaundice, abnormal enzyme levels, hepatitis and liver enlargement)
• eye injuries (whorl keratopathy)
• thyroid disorders (hyper or hypothyroidism)
• cancer

The concerns over the possible health risks associated with Amiodarone are serious enough for the drug to be required to bear two black-box warnings. Black-box warnings are the FDA’s most serious warnings associated with drugs. 

There is also some evidence that amiodarone used for atrial fibrillation may increase the risk of falling or fainting for older patients. According to a Danish study, patients over the age of 65 may be more likely to faint or fall after taking the anti-arrythmic drug. This risk may be due to reduced blood flow caused by amiodarone. It is most likely for falling and fainting to occur within two weeks after starting the medication, but the risk may continue to be elevated during the entire time the patient is on the drug.

Allegedly, the drug can cause sudden death or potentially deadly side effects including lung damage, liver damage, or irregular heartbeats. Because amiodarone may be linked to a worsening arrhythmia, the FDA notes that patients who are taking amiodarone for irregular heartbeats are often required to get their first dose a the hospital so they can be observed. This allows the physician to ensure that the drug works safely for the patient, and improves their condition. 

As the drug may be linked to multiple serious side effects, the FDA advises that it should only be used in the case of patients with serious arrhythmias. Healthline notes that taking some antibiotics with amiodarone may increase a patient’s risk for developing an irregular heartbeat. Amiodarone used for arrhythmia can also actually exacerbate the condition, causing it to become more serious. These serious side effects are why the FDA has approved amiodarone only as a treatment of last resort.

Healthline explains that the drug is commonly used in its oral tablet form, but also can be given as an injection in the form of a solution. In rare cases, some patients may begin their treatment with Amiodarone by being given the injection, and then continue their treatment with the oral tablet at home.

How Often is Amiodarone Used for Atrial Fibrillation?

Patients who undergo open heart surgery tend to be at an elevated risk for atrial fibrillation (AF) during the initial recovery period, according to the Mayo Clinic. Studies have found that for a brief period following such surgery, amiodarone is effective at reducing the incidence of AF. The same can be said for those suffering from acute onset atrial fibrillation; used for a short period of time, it can be effective.

However, there is little evidence to support its efficacy over the long term. To the contrary, most of the serious side effects appear to be dose-dependent, meaning the longer it is taken and the more of it that accumulates in the patient’s system, the greater the risk.

Considering the Risks, Why is Amiodarone Used for Atrial Fibrillation or Any Other Type of Arrhythmia?

Amiodarone is generally considered when other treatment options have been ineffective. In these cases, a physician must weigh the risks against the potential benefits. The problem is this caution has not always observed. Drug companies are accused of putting profits ahead of human health, encouraging doctors to prescribe it as a first-line treatment and even to treat conditions for which it is not approved.

Amiodarone Lawsuits

Several lawsuits pertaining to amiodarone have been filed by patients who have been harmed or by their families. One man whose family claims he was given an inaccurate amount of the drug died from amiodarone toxicity over the course of several months. Unfortunately, amiodarone toxicity is often irreversible. His wife and daughter claim that he was incorrectly dosed, leading to a higher level of the drug in his body than was safe.

Another family has filed a lawsuit regarding the drug after they claim that doctors prescribed amiodarone despite the man being allergic to the medication. He died of respiratory failure due to lung disease caused by exposure to the medication.

Victims of amiodarone side effects including lung toxicity may be able to pursue compensation and justice for these injuries. Families whose loved ones have died after taking amiodarone may be able to pursue compensation for wrongful death.