Did you or a loved one suffer from life-threatening side effects while taking amiodarone?
Amiodarone is an anti-arrhythmia medication that is also sold under the brand names Cordarone, Pacerone, and Nexterone. It is prescribed to treat irregular heartbeats.
The Food and Drug Administration approved the drug to be prescribed as a “last resort” because it has been linked to a number of serious and life threatening Amiodarone side effects, including the following:
- Lung disease/pulmonary toxicity
- Liver failure
However, some drugmakers were allegedly encouraging doctors to prescribe it to patients as a first line drug, and they may have also promoted the drug to treat conditions that it was not approved to treat.
If you or a loved one suffered from a serious amiodarone side effect, you may qualify to join this amiodarone toxicty lawsuit investigation.
Filing an amiodarone lawsuit may help you recover some of the medical costs and lost wages associated with the amiodarone injury.
See if you qualify by filling out the form on this page for a free case evaluation.
What is Amiodarone?
Amiodarone hydrochloride was first approved by the FDA in 1985 to be sold under the brand name Cordarone by the pharmaceutical company Wyeth.
The FDA approved amiodarone to treat patients who were suffering from a life-threatening irregular heartbeat caused by ventricular fibrillation and ventricular tachycardia.
Amiodarone helps patients return to a normal heart rhythm by cutting off the electrical signals in the heart that are causing the erratic heartbeat.
The federal agency states that it is to be used as a “last resort” and that “every effort should be made to utilize alternative agents first.”
What are the Amiodarone Side Effects?
The FDA has explained that amiodarone “is accompanied by substantial toxicity” including “fatal toxicities, the most important of which is pulmonary toxicity.”
The serious adverse side effects that Amiodarone has been linked to includes the following:
- Pulmonary fibrosis (scarring of lung tissue)
- Lung damage
- Hepatic failure (chronic liver failure)
- Neurotoxicity (damage to central nervous system)
- Peripheral neuropathy (damage to nerves in spinal cord)
- Neonatal hypothyroidism
- Optic neuritis
- Exacerbation of arrhythmias
- Congestive heart failure
- Cirrhosis (late stage scarring of liver)
- Kidney failure / Rhabdomyolysis (when combined with Simvastatin)
Amiodarone patients who suffered from one of the side effects listed above may be entitled to compensation.
The FDA has also warned that patients taking Cordarone should be closely monitored while taking the drug because of “the difficulty of using Cordarone effectively and safely itself poses a significant risk to patients.”
“Patients with the indicated arrhythmias must be hospitalized while the loading dose of Cordarone is given, and a response generally requires at least one week, usually two or more,” the FDA said.
“Because absorption and elimination are variable, maintenance-dose selection is difficult, and it is not unusual to require dosage decrease or discontinuation of treatment,” the federal agency added.
Why is Amiodarone Prescribed as a First-Line Drug?
Wyeth allegedly marketed Cordarone to be prescribed as a first-line anti-arrhythmia drug.
Even though the FDA never approved Cordarone to be presribe as a first line drug, Wyeth’s marketing campaign was reportedly so successful that doctors today still prescribe amiodarone as a first line drug.
The FDA sent letters to Wyeth warning that it stop promoting the drug beyond its approved uses.
Doctors are allowed to prescribe drugs for uses that a drug is not approved for, but a pharmaceutical company is prohibited from promoting drugs for unapproved uses.
This off-label use violation continued to be a problem even as the generic version of the drug became available.
For example, when generic drug maker Sandoz began selling the drug, doctors began presribing it to treat atrial fibrillation, which it is not approved to treat. Amiodarone was approved to treat recurrent ventricular fibrillation and hemodynamically-unstable ventricular tachycardia by the FDA.
It is believed by some that amiodarone is toxic and life-threatening to atrial fibrillation patients.
As the FDA has noted, one of the concerns with amiodarone is that it remains in the patient’s tissues for some time even after discontined use, which is why careful monitoring is recommended when patients are given the drug.
According to the British Pharmacological Society, “excessive accumulation in tissues is suspected as a possible cause of some of its adverse events.”
Sandoz has also been accused for failing to provide medication guides to amiodarone patients.
Other drug companies that have made and sold amiodarone drugs includes:
- Par Pharmaceutical, Inc.
- Taro Pharmaceuticals USA, Inc.
- Zydus Pharmaceuticals USA, Inc.
- Teva Pharmaceuticals USA, Inc.
- Barr Laboratories, Inc.
- EON Labs, Inc.
- Wyeth-Ayerst Laboratories, Inc.
Why File an Amiodarone Toxicity Lawsuit?
If you believe you or a loved one was injuried by an amiodarone side effect, a lawsuit gives patients a chance to hold the drug companies accountable.
In addition, an amiodarone toxicity lawsuit may result in compensation for the following damages:
- Medical bills
- Lost wages
- Pain and suffering
- Continued medical needs
- Reduced earning abilities
- Out-of-pocket expenses
If the injured party died, the surviving family members can also sue for funeral expenses and lost earnings.
The compensation received varies based on the injuries suffered and the damages that were incurred.
If you or a loved one suffered from amiodarone toxicty while taking the anti-arrhythmia drug, you may qualify to join this amiodarone lawsuit investigation.
Learn more by filling out the form on this page for a free case evaluation by a drug injury lawyer.
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