Cordarone is a heart drug that has been associated with many severe side effects, including lung damage (pulmonary toxicity), vision loss, blindness, and even death.
What is Cordarone?
Cordarone is a brand-name for amiodarone, a generic drug that treats irregular heart rhythm in the lower chambers of the heart. It is made by Wyeth-Ayerst (now owned by Pfizer) and was approved by the FDA in 1995.
What is the problem?
In May 2005, the FDA warned about the risk of pulmonary toxicity, liver damage, and worsening heart problems from Amiodarone. In patients on 400-mg/day, 17% developed lung damage, and 10% of cases were fatal. Irregular heart rhythm can also worsen and become very hard to treat.
Signs of Worsening Heart Problems
- Irregular heartbeat
- Heart palpitations
Symptoms of Pulmonary Toxicity
- Shortness of breath
- Irritating cough
- Coughing up blood
Other Health Problems
- Vision problems
- Loss of muscle coordination in arms and legs
Drug of Last Resort
The FDA recommends that Cordarone should only be used in adults with life-threatening ventricular arrhythmias after other treatments failed. The FDA has also says the side effects of Cordarone may persist after discontinuing the drug because it stays in your body for months after treatment is stopped.
FDA Warning: Cordarone + Zocor (simvastatin)
The FDA published a Safety Communication in December 2011 to warn about the risk of muscle damage and rhabdomyolysis when Cordarone is used with simvastatin, a cholesterol-lowering drug sold under the brand-name Zocor. The FDA limited the daily dose of simvastatin to 20-mg/day when it is combined with Cordarone.
What is Rhabdomyolysis?
In minor cases, muscle injuries associated with Cordarone + simvastatin involve minor breakdown of muscle fibers, called myopathy. Untreated myopathy can progress to a rapid degeneration of muscle tissues. This disorder is called rhabdomyolysis, and it can cause kidney failure or death.
Side Effects of Cordarone
According to the Medication Guide, the most serious side effects of Cordarone include:
- Lung toxicity
- Pulmonary fibrosis
- Liver damage
- Worsening irregular heart rhythm
- Vision problems
- Nerve problems, numbness, weakness
- Uncontrolled movements
- Skin reactions