Listed here are some good sources of information.
The sites I’ve listed at the bottom indicate conflicting views of Amiodarone use in the U.S.
The FDA clearly states indications of use for the drug and it is NOT for atrial fibrillation. It’s meant to be a last ditch effort for patients with ventricular fribrillation.
Nevertheless, the American Heart Association endorses the “off label” (i.e. not as directed on the label) atrial fibrillation which goes against FDA approval.
As I search the internet, I haven’t come across anything that states patients are required to be informed of risks in regards to this drug or any drug. Quite to the contrary, read the Consumer Reports article at the bottom and learn that doctors are not required to tell patients that the drug they are prescribing to them is not approved for that particular use by the FDA.
If you have an article you would like to have listed here , please email me the link at email@example.com
Medication Guide for Cordarone
About.com (Several articles)
New York Times (2 Legal Cases)
FDA Guildlines of Use for Amiodarone
FDA Guidelines to Providers Regarding Amiodarone
Medline (Who Should Use Amiodarone…People with life-threatening ventricular arrhythmias per FDA guidelines)
American Heart Assiocation (Shows Amiodarone being promoted in an “off label” use against FDA guidelines)
Consumer Reports “Off Label Drugs: What Does It Mean For You?”
Learn About Atrial Fibrillation
Patient Communication Study
Amiodarone Case Study