The side effects of Amiodarone can actually worsen an arrhythmia. Drug companies have marketed it as a first-line medication, contrary to what the FDA approved it for.
Amiodarone is a medication used to treat an irregular heartbeat and has been linked to lung damage and other life-threatening conditions. It goes under the brand names Cordarone, Pacerone, and Nexterone.
Have you experienced breathing problems, lung damage, or other serious side effects after taking amiodarone? Read more to find out if an amiodarone lawsuit is right for you.
Amiodarone History and Approval by the FDA
Amiodarone is a medication with an interesting history behind its development and incorporation into Western medicine. First developed by a Belgian company in 1961 to treat angina (a form of chest discomfort that can mirror symptoms of a heart attack), amiodarone became a popular treatment in Europe and South America.
Gleb von Anrep, a physiologist working in Cairo, Egypt, initially observed the healing properties of the Khella (Ammi visnaga) to treat angina in the 1940’s. It was after this that Khella was derived and developed into a medication, amiodarone, to treat angina.
After 1961, amiodarone began catching the attention of physicians in Europe. Based on his observations, Bramah Singh of Oxford University, concluded that the new drug had antiarrhythmic properties. The trendsetting of amiodarone caught on in the United States in the 1970’s as a treatment for life-threatening arrhythmias.
By 1985, the Food and Drug Administration finally approved amiodarone hydrochloride (under the name Cordarone) to treat irregular heartbeat conditions manifested by ventricular fibrillation (VF) and ventricular tachycardia (VT).
Technically, amiodarone works by cutting off the electrical signals to the heart that causes an erratic heartbeat. But this miracle drug can come with some hefty side effects and negative health conditions.
Side Effects of Amiodarone Medications
The FDA has indicated amiodarone should only be used as a last resort when other medications don’t work, due to the severity of its side effects. It is believed that it can exacerbate and worsen those with atrial fibrilation.
Many patients have to be hospitalized for at least a week when first taking amiodarone so their physician can monitor any symptoms that may develop. Many doctors start with a high dosage and gradually wean the patient down if the medication works. However, if any of the adverse side effects begin to appear, those patients will be taken off amiodarone.
The FDA is concerned that amiodarone can stay in the tissue of a patient, even after discontinuation. As reported by the British Pharmacological Society, “excessive accumulation in tissues is suspected as a possible cause of some of its adverse events.”
For women who plan to become pregnant, or are currently pregnant, amiodarone can cause fetal harm. This is one of the many reasons why it’s important to stay vigilant of how your body is responding after being taken off of amiodarone.
Many of the amiodarone side effect include:
- Pulmonary fibrosis (scarring of lung tissue)
- Lung damage
- Hepatic failure (chronic liver failure)
- Neurotoxicity (central nervous system damage)
- Peripheral neuropathy (damage to the nerves in the spinal cord)
- Neonatal hypothyroidism
- Optic neuritis
- Exacerbation of arrhythmias
- Congestive heart failure
- Cirrhosis (late-stage scarring of the liver)
- Kidney failure / Rhabdomyolysis (especially when combined with Simvastatin)
If you have ever been diagnosed with liver disease, amiodarone can exacerbate liver damage. Some of the symptoms that may occur while taking amiodarone may include:
- Dark colored urine
- Excessive fatigue
- Yellowing of the skin or eyes (jaundice)
- Pain in the upper right stomach
Furthermore, one of the side effects of taking amiodarone is that it can actually worsen an irregular heartbeat or cause new arrhythmias. If you feel dizzy, faint due to a slow heartbeat, have low levels of potassium or magnesium in the blood, heart or thyroid disease, or anything else that contributes to a heart rhythm problem, speak with your doctor immediately.
Amiodarone as a First-Line Drug?
Amiodarone has been manufactured under the brand names Cordarone, Pacerone, and Nexterone.
Cordarone’s manufacturer, Wyeth (a subsidiary of Pfizer, Inc.), originally marketed the drug as a first-line anti-arrhythmia drug. But the FDA never approved Cordarone for first-line use. Furthermore, a pharmaceutical company cannot promote drugs for unapproved use.
As mentioned earlier, the FDA has only approved amiodarone to treat ventricular fibrillation and hemodynamically-unstable ventricular tachycardia, only when other medications have ceased to work.
Though doctors are allowed to prescribe medications for conditions it was not initially approved for, the damage by the pharmaceutical company was already in place. Many physicians are still under the assumption that amiodarone is safe for treating an arrhythmia.
What this means is that regardless of the negative side effects, the drug company pushed to incorporate Cordarone into mainstream, every day usage– putting thousands of people at risk.
In 2004, the FDA required a medication guide be included in prescriptions for Cordarone that outline intended use, as well as complications that may arise while on it. For instance, it warns not to drink any grapefruit juice during treatment because it can increase the amount of the medication in your blood system. Similarly, Cordarone can cause your skin to be very sensitive in sunlight, leading to sunburn.
Other companies that have sold amiodarone medications for use in the United States include:
- Par Pharmaceutical
- Taro Pharmaceuticals
- Zydus Pharmaceuticals
- Teva Pharmaceuticals
- Barr Laboratories
- EON Labs
- Wyeth-Ayerst Laboratories