Aratac contains the heart drug amiodarone, which is associated with severe toxicity in many areas of the body. Side effects include lung disease (pulmonary toxicity), blindness, and even death.

What is Aratac?

Aratac is an international brand-name version of the generic medication amiodarone. The drug is manufactured by the Australian generic-drug company Alphapharm.

What Does Aratac Treat?

Aratac is used to control irregular heart rhythm of the two lower chambers of the heart (ventricular arrhythmias). It belongs to a class of drugs called anti-arrhythmics, which work by relaxing over-active heart muscles.

What is the problem?

Amiodarone has been on the market for decades. Due to its long history, it has become apparent that amiodarone causes toxicity of organs, especially the lungs. It has been associated with vision loss, blindness, muscle problems, worsening cardiac arrhythmia, and many other life-threatening side effects.

FDA Safety Warnings

The FDA has issued a Safety Communication to warn about lung disease (pulmonary toxicity), liver damage, and worsening heart problems from Amiodarone. About 17% of patients on 400-mg daily doses develop lung damage, and 10% of cases are fatal.

Last Resort Drug for Severe Heart Problems

Amiodarone should only be used as a last resort by adults with life-threatening ventricular arrhythmias after other medications have failed. It also stays in a patient’s body for several months after they stop using it. Side effects may also persist. Certain lung abnormalities may take up to 18 months to subside after discontinuation of the drug.

Symptoms of Worsening Heart Problems

  • Light-headedness
  • Fainting
  • Irregular heartbeat
  • Heart palpitations

Lung Damage and Pulmonary Toxicity

  • Fever
  • Shortness of breath
  • Wheezing
  • Irritating cough
  • Coughing up blood

Other Health Problems

  • Fatigue
  • Vision problems
  • Numbness
  • Loss of muscle coordination in arms and legs

FDA Warning: Aratac + Zocor (simvastatin)

The FDA has published a Drug Safety Communication regarding the risk of degenerative muscle disease when amiodarone is combined with Zocor (simvastatin), a popular cholesterol-lowering medication. In December 2011, the FDA warned not to combine amiodarone with more than 20-mg of simvastatin per day due to the risk of muscle disease.

Aratac and Rhabdomyolysis

Combining Aratac with more than 20-mg of simvastatin is associated with an increased risk of muscle disease. Mild cases cause the breakdown of muscle fibers. Without treatment, it can lead to rhabdomyolysis, which occurs when damaged muscle fibers release large amounts of protein (called myoglobin) which clogs the kidneys and causes organ damage. It can potentially cause kidney failure and death.

Side Effects of Aratac

  • Lung damage
  • Pulmonary fibrosis
  • Liver damage
  • Worsening irregular heart rhythm
  • Cardiac arrest
  • Thyroid gland dysfunction
  • Vision problems
  • Permanent blindness
  • Nerve disorders (weakness, numbness, tingling)
  • Uncontrolled muscle movements
  • Skin diseases
  • Death
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