The heart drug Amiodarone has been associated with severe lung disease, blindness, and death. The FDA warns that it should only be used as a last resort.
What is Amiodarone?
Amiodarone is a medication that has been approved by the FDA to treat irregular heart rhythms, including atrial fibrillation and atrial flutter. Amiodarone is also sold under the brand-names Pacerone, Cordarone, and Aratac. It is also frequently prescribed off-label for conditions not approved by the FDA.
What is the problem?
In 2005, the FDA issued a Safety Warning about severe side effects of Amiodarone. About 17% of patients on 400-mg doses develop pulmonary toxicity, a severe type of lung damage that is fatal in 10% of cases. Amiodarone can also damage the liver and worsen a patient’s irregular heart rhythm. All of these side effects can be deadly.
Symptoms of Worsening Heart Problems
- Light-headedness
- Fainting
- Irregular heartbeat
- Heart palpitations
Lung Toxicity Symptoms
- Fever
- Shortness of breath
- Wheezing
- Irritating cough
- Coughing up blood
Other Serious Health Risks
- Fatigue
- Vision problems
- Numbness
- Loss of muscle coordination in arms and legs
Amiodarone and Simvastatin
One of the most concerning drug combinations is amiodarone + simvastatin (Zocor), a popular statin medication used to reduce high cholesterol levels. In 2008, the FDA issued a warning after receiving 52 adverse event reports of rhabdomyolysis since 2002.
What is Rhabdomyolysis?
Rhabdomyolysis is a degenerative muscle disease that affects skeletal muscles. The condition can be life-threatening. It occurs when the skeletal muscles break down and release myoglobin, a muscle protein, into the bloodstream. This muscle protein can clog the filtering system in a person’s kidneys, potentially causing kidney damage or kidney failure. In severe cases, the muscle disease may also reduce circulation and cause tissue damage in the body.
Amiodarone Side Effects
Patients on amiodarone may experience severe lung damage and other severe side effects, including worsening irregular heart rhythm, vision problems, and more. Contact your doctor if you have symptoms, such as:
- Fever
- Shortness of breath
- Wheezing
- Irritating cough
- Coughing up blood
- Light-headedness
- Fainting
- Irregular heart rhythm
- Heart palpitations
- Fatigue
- Vision problems
- Numbness
- Loss of muscle coordination
Amiodarone Class Action
Lawsuits have been filed by people who were injured by amiodarone, but not as part of a class action. In June 2016, federal judges rejected an attempt to centralize the cases at the federal level.