Pacerone side effects have been linked to serious injuries from patients who have taken the medication.

Because the side effects can be dangerous and even life-threatening, the FDA has approved Pacerone (also known as amiodarone) for the treatment of arrhythmia only after a patient’s condition has failed to respond to other medications.

Patients who have filed lawsuits against drugmakers claim that they have been encouraging physicians to prescribe Pacerone as a first-line treatment and may have been engaging in illegal marketing for “off-label” use.

What is Pacerone?

Pacerone (generic name: amiodarone) is prescribed for the treatment and prevention of irregular heartbeat, or arrhythmia, that may be due to any number of heart conditions, including:

• atrial fibrillation
• paroxysmal supraventricular tachycardia
• ventricular fibrillation
• ventricular tachycardia
• wide complex tachycardia

Pacerone is unusual among pharmaceuticals. Unlike most medications, which enter the bloodstream and circulate for a period of time before it is metabolized or excreted, Pacerone builds up in the body’s tissues over time. Because of this, the full therapeutic benefits are not fully achieved for several weeks when taken orally. A prescribing doctor will start a patient on a large dose (up to 1600 mg. per day) for the first few weeks in order to allow the drug to build up in the tissues, then dial back the dosage to maintenance levels (100-200 mg. daily).

In serious cases of arrhythmia, it can be injected directly into the bloodstream (intravenously) or bone marrow (intraosseously). These methods of administration can speed up the therapeutic effects. Once the medication is discontinued, it can take weeks or even months for Pacerone to leave the body.

What About Pacerone Side Effects?

There are a number of serious Pacerone side effects, and most patients who are given the drug will experience at least one of them. The most serious of these is pulmonary toxicity, or interstitial lung disease (ILD). This is a general term referring to a number of illnesses affecting the respiratory system, the most serious of which is pulmonary fibrosis, or a build-up of scar tissue in the lungs.

Pacerone can also cause abnormal thyroid function or liver disease including jaundice, enlarged liver, hepatitis, and pseudo-alcoholic cirrhosis.

In June of 2011, the U.K. based Centre for Adverse Reactions Monitoring reported having received over 50 reports of eye-related Pacerone side effects. Corneal deposits affect approximately nine out of ten patients who take Pacerone or another form of amiodarone. Optic neuropathy, or destruction of the optic nerve, occurs about two percent of the time.

In April of 2013, a Chinese research team published results of a study linking amiodarone with an elevated risk of cancer, primarily affecting males.

What is the Legal Issue Surrounding Pacerone?

Because of the serious side effects, Pacerone is not recommended as a first-line treatment. A licensed physician may prescribe a medication for “off-label” use if, in his or her professional medical opinion, it is the best treatment option for a patient – but FDA regulations prohibit drug companies from promoting their products for such use.

At least two drug companies who manufacture their own versions have been accused of doing just that, despite warnings from the FDA – and patients may have suffered injuries or death as a result.