It is very easy to complete and people we have spoken with Â at the FDA have assured us that they do act on the “quantity and quality of reports” they receive. It requires no registration to complete and takes only a few minutes if you are prepared with the information you’ll need before you begin.
Before you start:
— you will need to create a patient identifier name which is not your (or your loved one’s) real name or SSN. A nickname or code name will do, like Wyoming Bill or 1925Mom. (You may want to write this down so that you can refer to it later.)
–know the age or date of birth of the person who suffered the adverse effect
–know the weight of the person
–know the BRAND name of the amiodarone that was prescribed, the dosage, how long it was taken, any changes in dosage, when it was ceased, etc.
–type out a rough draft of your narrative report before you start typing on the form. Be careful to spell things correctly and to write in clear, understandable full sentences. Include all relevant information, but try to stick to the point: how you or your loved one was prescribed amiodarone, how symptoms began to appear and progressed, how doctors responded to these symptoms, if at all, what treatments were given once amiodarone toxicity was suspected, etc. Include what you were told about the drug’s use or possible side effects. Have any significant dates clear in your mind, and proofread your draft for errors before you get ready to type it onto the FDA form.
Click BEGIN on the right hand side to start.
FIRST PAGE: you’ll use your Patient Identifier name here, and record age and weight.
#1. Check the box that says ADVERSE EVENT.
#2. Check “Death” and record date if your loved one died of amiodarone toxicity. Check one or more of the other options if you have survived toxicity.
#3. Date of event is not really relevant when you are reporting toxicity that developed over days, weeks, months or even years. Either put the date of death, or if you are a survivor, date use began or ended.
#4. Date of report will auto-fill.
#5. This is where you want to type in the full report of how you or your loved one came to be given amiodarone, how long you took it, how symptoms developed, what treatments were pursued, what attitudes or awareness doctors or pharmacists showed. Please be as specific as possible.
#6. If you know the dates and types of tests which showed conclusive damage to lungs, nerves, eyes, liver, please list them as clearly as possible: type of test, date of test, where performed, results.
Do you still have the prescription bottle? Check yes or no. It’s unlikely anyone has ret’d it to manufacturer (remember this is a generic form for both prescription and OTC medications/medical devices, and not all questions will pertain to your situation)
In #1, record the brand name and strength of the amiodarone that was taken. (For example: Cordarone, 200 mg). In #2, record the dosage and how often taken (Ex: 200 mg, twice daily). “ROUTE” means how was it taken: ORAL is hard to find on the pull-down list, but it’s there in the O’s and is what you should select if pills were taken. INTRAVENOUS (not otherwise specified)” will probably suffice if it was given by injection. In #3 record how long it was taken. #4 asks why it was prescribed. #5 asks if symptoms went away after its use was discontinued. The next two questions are for over the counter drugs and are not applicable for prescription amiodarone. #8 asks if symptoms ret’d after taking amiodarone again (it’s unlike this will apply to any of you).
You can skip–this is all about faulty medical devices.
Also not applicable to reporting amiodarone toxicity.
This is where you provide your name and information. Please read the CONFIDENTIALITY STATEMENT first: it makes it clear that your name will not be made public, and may not be released to the manufacturer of the drug without your explicit permission in Sec. 5 of this page.
Otherwise, this section is all straightforward. On #3, Occupation, select “CONSUMER/Non-Health Professional” if you are the affected person or the family member making a report.
Lastly, and most importantly, click SUBMIT REPORT! If anyone wants help editing their report, feel free to contact me here and I’ll help!