Amiodarone / Pacerone

Amiodarone (brand name: Pacerone) is a prescription drug used to treat atrial and ventricular cardiac arrhythmias. It was developed by a Belgian company in 1961 as a drug for treating angina (chest discomfort related to coronary artery disease) and quickly became a popular anti-angina drug in Europe and South America. Its brand names are Cordarone and Pacerone.

It was approved for use in the United States in 1985. For some time, the FDA was reluctant to approve amiodarone because of its link to serious pulmonary side effects. The drug is used by both men and women to treat arrhythmia, but its serious side effects seem to only show themselves in women.

There is an increased risk also when doctors prescribe amiodarone for off-label use, without informing the patient about the possible side effects, or that the FDA had not approved its treatment as safe and effective. In 2004, Amiodarone was prescribed to 2.3 million patients, and 82 percent of these were not for approved conditions.

Many patients suffering from severe side effects such as lung damage, Toxic Epidermal Necrolysis (TEN) and blindness say that their doctor did not adequately inform them of the risks associated with the drug. In certain studies, up to 17 percent of patients suffered from lung damage with 10 percent of patients dying as a result of these damages.

Amiodarone is for use only in life-threatening situations. This medication has the potential to cause side effects that could be fatal, and patients should only receive their first few doses in a hospital setting.

Side effects may include:

• Abnormal skin sensations (loss of sensation, tingling, numbness, prickling)
• Bitter taste in mouth
• Blue-green discoloring of skin (especially hands or feet)
• Constipation
• Decreased sexual interest
• Dizziness
• Dry eyes
• Flushing of the face
• General body discomfort
• Headache
• Involuntary muscle movements
• Loss of appetite
• Nausea
• Poor coordination
• Tiredness
• Trouble sleeping
• Vomiting

More severe side effects may include:

• Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue)
• Chest pain
• Chills
• Coldness
• Cough
• Coughing up blood
• Dark urine
• Decreased urination
• Easy bruising or bleeding
• Enlarged thyroid gland
• Eye discomfort
• Fatigue
• Fever
• Irregular pulse
• Loss of coordination
• Menstrual changes
• Muscle pain, tenderness, or weakness (especially with fever or unusual tiredness)
• Nervousness
• Persistent sore throat
• Severe dizziness
• Severe stomach pain
• Shortness of breath
• Skin reaction similar to serious sunburn
• Slow heartbeat
• Sluggishness
• Sweating
• Tingling or numbness of hands or feet
• Uncontrolled shaking or tremor
• Unexplained weight change
• Vision changes (seeing halos, blurred vision, loss of vision)
• Wheezing
• Worsening of irregular heartbeat
• Yellowing of the skin or eyes.