How to Report an Adverse Drug Reaction to the FDA

Topical Steroid Addiction is awful. No two ways about it. When a patient suffers an adverse reaction from a drug or medicine, they can feel helpless and let down. But there is a way that we can empower ourselves and hopefully prevent future generations from suffering from the same fate; by reporting our symptoms to the relevant authority.

But how do we go about doing this? And is there any point in doing so?

How to Report an Adverse Drug Reaction:

How you go about reporting a drug will depend on which country you live in. Different countries have different procedures. Below is a list of some of the main ones:

USA: Medwatch

Those living in the USA can report adverse drug reaction to Medwatch, the official FDA channel. The site states that:

"By reporting your experience or suspicion of a product problem to MedWatch you could help identify an unknown risk and potentially spark a variety of actions—from changes to a warning label to removal of the product from the market."

UK: Yellow Card

In the UK, there is a scheme called Yellow Card. It is run by the MHRA. The website form is easy to use and can be used to report any side effects from medicines.

New Zealand: Vigilance Centre

A similar scheme for patients in New Zealand.

Canada: MedEffect

Patients in Canada can report drug reactions on the Vigilance Program website, by phone or by post.

What to Report?

Curgolf from the Itsan forum produced this handy guide to reporting. Thanks Curgolf.


Some suggestions when filling out the form:

Product:  List all the TS/steroid products you used

Company:  List all the companies

Expiration date: Write: "Used all products before expiration dates." 

Lot Number: list all if you have them

NDC #:  National Drug Code is a 10-digit code to identify drugs.  Google "NDC directory or National Drug Code directory" and search each drug by name., e.g., mometasone.

If you threw all away and can't remember the doses/product info, call your pharmacy.  They should be able to print out a list of all the drugs you've taken. While you're at it, ask them for the NDC codes to each and maybe save yourself a step.

You can fill out the form online but need to print it out for a copy--the site does not save what you enter.
If your information cannot fit in the space provided, put the rest of the info on additional paper "write: "See Attached") and send it in with the main form.

***One section says, "Tell us what happened and how it happened." LET"S TELL THEM!  include colored pictures if you want, especially of the hallmark signs of TSW:
Red skin all over but white hands, tons of flaking shedding skin, oozing, purple legs, swelling, etc. LET them SEE hell on earth!

Make a copy for yourself and one for the FDA.  Mail or fax to the FDA listed on the form at the bottom of page 3.  Save all the documents you send, or send copies to Dr. Fukaya and Dr. Rapaport, so they can have additional evidence of existing Red Skinners when NEA interviews them. 
Send a copy to the NEA., knowing they may reject them because they are not "official research," but at least they'll know we're out here.

Is it all Worth it?

You may wonder if there is any point reporting your TSW to the authorities. You may wonder if anyone is listening. But I have proof that they are listening. Please check out this link to the Medsafe site that states the dangers of steroid use on the face. They received 14 complaints and produced this document. Imagine what they would do if even more people reported side effects.

In the document: Steroid Rebound-A Topical Issue we have the example of a man who reported the steroid side effects to Medsafe after having a bad reaction to 0.5% hydrocortisone. I am pleased to report that the man is now fully healed from all withdrawal symptoms after an 11 month withdrawal period (His father is a member of the Itsan forum and provides us with updates).

Please, if you haven't filled in one of these forms, please do. It is one way that you can make a real difference and maybe even change the world!