Patients who took the cardiac drug admiodarone and later suffered serious side effects may be able to seek compensation in court.  

Amiodarone is a prescription drug used to treat certain types of serious irregular heartbeat conditions. It’s sold under the brand names Cordarone, Pacerone, and Nexterone.  Because of its potential to create serious and sometimes fatal side effects, it was originally approved for use only as a last resort, when other treatments had failed.

Nevertheless, there have been reports suggesting that the manufacturers aggressively marketed it as a first-line treatment, leading many doctors and patients to believe it was safer than it was.

What is an Irregular Heartbeat?

An irregular heartbeat or heart arrhythmia is a condition in which the heart doesn’t beat as it should.  It may beat too fast, for example, too slow, or irregularly.  Some types of heart arrhythmias are harmless, but others can cause bothersome or even life-threatening complications.

In a healthy person, heart rhythm is controlled by a natural pacemaker inside the heart called the sinus node.  It produces electrical impulses that start each heartbeat, causing the muscles to contract and pump blood.

Various types of arrhythmias may occur when there is a problem with the sinus node, the nerves, or the heart muscle itself.  These include:

• Bradycardia: the heart beats more slowly than normal.
• Tachycardia: the heart beats faster than normal. There are two main subtypes of tachycardia.
  • Supraventricular tachycardia: the problem occurs in the upper chambers of the heart known as the atria.
  • Ventricular tachycardia: the problem occurs in the lower chambers of the heart known as the ventricles.
• Irregular heartbeat: the heart beats in an abnormal rhythm sometimes described as a flutter or fibrillation. The three main subtypes include:
• • Atrial fibrillation (AFib): The upper chambers of the heart beat quickly and irregularly, creating a quiver more than a beat. This is a serious type of irregular heartbeat that can lead to blood clots, stroke, and heart failure.
  • Atrial flutter: The upper chambers of the heart beat faster than the lower ones, putting the rhythm out of sync. This condition can also cause stroke and heart failure, but it’s typically not as serious as atrial fibrillation.
  • Ventricular fibrillation: The problem originates in the ventricles, and causes the heart to beat with rapid, erratic impulses, leading to a heart quiver. This condition can cause blood pressure to plummet and often requires emergency care.

Most types of irregular heartbeat are not severe and don’t cause any health complications.  Some, however, as noted above, can increase the risk of blood clots, stroke, and heart attack.

What is Amiodarone?

Amiodarone is the generic name for an anti-arrhythmic drug used to treat and prevent certain types of serious, life-threatening ventricular arrhythmias such as ventricular tachycardia and ventricular fibrillation.  It comes as a tablet taken once or twice a day, and is also available as an intravenous (IV) solution for injection, meant for administration by a healthcare provider.  It works directly on the heart tissue, slowing the nerve impulses and relaxing overactive heart muscles.  This helps keep the heart beating more regularly.

The first amiodarone drug to come onto the market was Cordarone, manufactured by drugmaker Wyeth Laboratories, which is a subsidiary of Pfizer, Inc.  The company received FDA approval to market the drug in 1985.

In the approval package, the FDA noted that Cordarone was indicated “only for the treatment of the following documented, life-threatening recurrent ventricular arrhythmias when these have not responded to documented adequate doses of other available antiarrhythmics or when alternative agents could not be tolerated:

1. Recurrent ventricular fibrillation
2. Recurrent hemodynamically unstable ventricular tachycardia”

From the very beginning, the FDA meant for this medication to be used only when other medications had failed to treat the arrhythmia—that is, as a last resort.  That’s because amiodarone can cause serious side effects, and the FDA was aware of these early on.

Later in the approval letter, the agency stated, “Because of the unique pharmacokinetic properties, difficult dosing schedule, and severity of the side effects if patients are improperly monitored, Cordarone should be administered only by physicians who are experienced in the treatment of life-threatening arrhythmias who are thoroughly familiar with the risks and benefits of Cordarone therapy, and will have access to laboratory facilities capable of adequately monitoring the effectiveness and side effects of treatment.”

Despite these initial directions, Wyeth and other manufacturers aggressively marketed amiodarone as an initial, first-line anti-arrhythmic medication, an “off-label” use that put public health at risk.

“Off-Label” Prescriptions of Amiodarone Increase Despite Side Effects

When the FDA approves a drug, it identifies exactly which conditions the drug is approved to treat.  The manufacturer may then advertise that drug as a treatment only for that condition.  While doctors have the choice to prescribe the drug for other purposes—so-called “off-label” purposes—it is illegal for the manufacturer market it for off-label unapproved conditions.  Sometimes, however, manufacturers ignore the rules to increase the sales of their products.

Wyeth was the first to market and sell amiodarone, then Sandoz and Upsher-Smith received FDA approval to sell generic forms of the drug in 1998.  Sandoz called its medication by its generic name, amiodarone hydrochloride, while Upsher-Smith called its product Pacerone.  It has been alleged that both companies worked to increase the sales of amiodarone without providing adequate warnings about its serious risks.

A magazine-style brochure from Wyeth, for example—used to advertise the drug in the later 1990s and early 2000s—was titled, “Amiodarone From Last to First-Line Antiarrhythmic Therapy.”  The FDA sent warning letters to amiodarone makers in 1989, 1992, and 1998, urging them to stop false and misleading promotions that downplayed the drug’s risks while suggesting its use as a first-line therapy.

In the January 1, 2003 issue of the American Journal of Cardiology, Al-khatib and colleagues reported that the number of prescriptions for class III antiarrhythmics more than doubled between 1995 and 2000, mainly due to an increase in prescriptions for amiodarone.  The scientists added that some doctors could be prescribing the drug for ischemic or hypertensive heart disease—a practice for which there was no clear evidence.

That same year, an investigation by the Knight-Ridder news organization reported that 82 percent of all amiodarone prescriptions written in the U.S. in the 12 months ending July 31, 2003, were for atrial fibrillation and other off-label indications.

In response to these findings, the FDA took action, requiring manufacturers to be clear about the drug’s risks.  In mid-January, 2005, the Agency and Wyeth Pharmaceuticals sent out “Dear Doctor” and “Dear Pharmacist” letters notifying recipients that a new medication guide with information about amiodarone’s serious side effects must be dispensed to patients with every prescription.  The purpose was to better inform patients about the potential dangers associated with the drug.

According to a 2005 FDA alert, amiodarone has several potentially fatal side effects.  The most important of these is pulmonary (lung) toxicity, which has occurred at rates as high as 17 percent in some of the patients with ventricular arrhythmias given doses of around 400 mg daily.  Pulmonary toxicity is fatal about 10 percent of the time.

This potential side effect is so serious that the FDA required each amiodarone product to have a boxed warning—the most serious type—on the label.  This warning alerts the user to the fact that the drug is associated with “several potentially fatal toxicities, the most important of which is pulmonary toxicity….”

Amiodarone can also make ventricular arrhythmias worse.  This has occurred in about 2-5 percent of patients, with the effects lasting longer than with other anti-arrhythmia medications because amiodarone is slowly metabolized and takes months to be washed out of the body.

The medication guide highlights some of these serious and potentially fatal side effects and provides general information to the patient about amiodarone. It also advises patients to consult with their physicians if they experience any side effects.  From 2005 forward, pharmacies were required to distribute these guides to patients receiving amiodarone.

Studies Link Amiodarone to Serious Side Effects

While the manufacturers continued to tout the benefits of amiodarone, several studies indicated that the drug was dangerous and should be used with great caution.

In 1994, for instance, researchers reported that while amiodarone was effective in patients with atrial fibrillation, it was to be used as a last resort because of its serious side effects including pulmonary fibrosis (scarring), thyroid dysfunction, and neurotoxicity.  The medication could also cause adverse interactions when used with digoxin, Coumadin, and other antiarrhythmic drugs.

In 2014, researchers reviewed amiodarone’s side effects and reported that the incidence of adverse effects from the drug was 15 percent in the first year of use, increasing to up to 50 percent during long-term use.

In 2019, researchers reported in the Journal of Geriatric Cardiology that amiodarone was increasingly prescribed in older people, and though it was an efficient drug for rhythm control, “it’s a carrier of diverse reaction, and pros and cons must be carefully evaluated before its use especially in older people.”  They later noted that the drug should be considered only after other medications failed “because of its potential organ toxicity.”

Types of Injuries Associated with Amiodarone

Intake of Amiodarone may cause the following injuries:

• Pulmonary lung disease
• Pneumonia
• Lung toxicity
• Stiffening of the lungs (pulmonary fibrosis)
• Bradycardia
• Thyroid abnormalities
• Vision changes, vision loss, and blindness
• Liver damage and liver failure
• Neurotoxicity (central nervous system damage)
• Exacerbation of arrhythmias
• Heart failure
• Stroke
• Hepatitis
• Kidney failure
• Death

Amiodarone Lawsuits

Some amiodarone lawsuits have already been filed in court. In 2015, for instance, the family of an Alabama athletic director filed a wrongful death lawsuit against amiodarone drug makers, claiming the medication caused the director’s death.

The decedent took amiodarone for 90 days in 2008 to treat an irregular heartbeat, and five years later was diagnosed with advanced pulmonary fibrosis, which he blamed on the medication.  His condition quickly worsened and he died on March 30, 2013.  The plaintiff alleged that the drug makers aggressively marketed amiodarone as a first-line treatment instead of as a last resort.

If you took amiodarone and later suffered from liver damage, lung damage, vision loss, or other serious side effects, you may be eligible to file an amiodarone lawsuit to recover damages.