What Are Amiodarone's Risks?Nov 24, 2004 | Miami Herald The drug's FDA-approved prescribing label for doctors, which patients rarely see, warns that the drug comes with ''substantial toxicity.'' About three-fourths of all patients taking a 400 mg dose experienced some side effects.
Lung toxicity, which has harmed as many as 17 percent of patients in some studies and has been fatal about 10 percent of the time.
Injury to the liver. While usually mild, it too can be fatal.
Worsening of the heart rhythm problem.
When given to pregnant women, the drug has caused serious harm to the fetus. Other side effects include thyroid problems and neurological disorders. Vision problems and blindness also have been reported.
Should patients take amiodarone for atrial fibrillation?
The FDA hasn't approved amiodarone to treat atrial fibrillation. However, doctors are free to prescribe it ''off label'' after weighing the risks and benefits.
According to the latest research, particularly a major National Institutes of Health study called AFFIRM, experts say amiodarone generally isn't the first drug a patient should try for atrial fibrillation.
Other options include a procedure to destroy the misfiring electrical connection in the heart. Patients also can be treated with various rhythm-control drugs.