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Heart Drug Amiodarone Has High Risk of Rhabdomyolysis

by admin on May 7, 2012 in Defective Drugs

Amiodarone Rhabdomyolysis Risk

Amiodarone is normally prescribed for atrial fibrillation and other common heart conditions.

However, the FDA only approved amiodarone for more severe disorders called ventricular arrhythmias as a treatment of last resort.

Various adverse side effects have been reported as a result of taking heart drug Amiodarone (cordarone), including rhabdomyolysis.

Taking other statin drugs while also taking amiodarone may also increase the risk of developing rhabdomyolysis, a severe skeletal muscle injury.

From 1997 to 2002, the FDA Medwatch reported over 3,900 adverse events associated with amiodarone, including 452 deaths.

The FDA continues to receive reports of patients on the amiodarone and simvastatin combination that develop rhabdomyolysis, which can lead to kidney failure or death.

Most of these reported injuries were severe enough to require while others involved blindness or permanent damage to lungs, liver, thyroid or the nervous system.

Causes of death include:

  • Respiratory failure due to lung damage
  • liver failure
  • kidney failure
  • failure of multiple organs (e.g. lung, liver and kidney)
  • congestive heart failure
  • heart arrhythmias (including sinus arrest, ventricular tachycardia, cardiogenic shock, and torsades de pointes)
  • stroke and bone marrow depression

Amiodarone has been approved for problems with the ventricles (large pumping chambers) of the heart, but not for fibrillation (quivering) of the atria (small chambers of the heart).

In October 2003, the FDA asked Wyeth to issue an advisory on amiodarone concerning its toxicity and off-label use.

In January 2005, the FDA and Wyeth notified health care providers of the new medication guide to be dispensed with every prescription of amiodarone and its generic equivalents.

The medication guide states that amiodarone can cause serious side effects that can lead to death including:

  • lung damage
  • liver damage
  • worse heartbeat problems”

Simvastatin

Simvastatin, a medication (statin) for lowering cholesterol, is often prescribed for treating coronary heart disease and reducing heart attack risk.

In conjunction with amiodarone, simvastatin side effects include life-threatening rhabdomyolysis.

Other side effects may include:

  • Muscle cramps and aches
  • Joint pain
  • Memory loss
  • Insomnia
  • Depression
  • Anxiety
  • Allergic reaction
  • Breast development in boys (gynecomastia)
  • Pancreatitis
  • Hepatitis
  • Worsening of cataracts
  • Itchy skin
  • Unexplained rash
  • Eczema
  • Impotence (also known as erectile dysfunction or ED)
  • Increased liver enzymes
  • Spinning sensation (vertigo).

If you develop symptoms or signs of rhabdomyolysis (dark, cola-colored urine, usually with muscle aches, pain and weakness), you should stop taking statin drugs and contact your health care provider immediately.

Amiodarone Class Action Lawsuit

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