FDA Reporting: Adverse Effects

Want to report adverse side effects? You don’t need to wait for your doctor. In fact, with Red Skin Syndrome, many adverse effects aren’t getting reported.

So let’s be proactive.

Visit the Food and Drug Administration page: FDA WEBSITE.

I apologize for this is only an American site, but others out of the country may be able to find your own government page to report adverse effects.

The papers you should fill out are the Consumer Voluntary Reporting Form

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When you go to mail or fax the pages, you can also attach a picture of the product you are reporting. Do not physically send them your product, but keep it in case they want to contact you for more information.

The FDA will reply to you so you know that your paperwork was received.

You want to fill out Sections A, B, D and E. Don’t worry if you aren’t able to answer every single question. Just fill it out as best you can.

Also, the FDA have the ability to share your name and contact information with the company that produced your product. If you want your information private, make sure to check the box in Section E.

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Any questions, you can call their toll free number, 1-800-332-1088

Once the forms are complete, mail them to:

MedWatch, Food & Drug Administration 

5600 Fishers Lane

Rockville, MD 20857

If you’d rather fax, the toll free number is, 800- 332- 0178

Good luck, guys! Let your voices be heard! 

Prescription Without A Cause

It’s not the steroid itself I have a problem with in the medical community. No. It is the overprescription & the lack of detective work to see if the patient even NEEDS the steroid that can cause so much harm when abused. That is what I have a problem with…

Take this dentist for instance. Here is the article that surfaced about his intense struggle with facial eczema.

Link to full article about Dr. Frances Tavares 

This dentist, Dr. Frances Tavares, was not only misdiagnosed and mistreated, but then had to deal with Red Skin Syndrome because of his overprescription of topical steroids (on his face no less). We already know that the face is one of the most sensitive areas/high absorption spots on the body. To use topical steroids on the face is already a risk, but then for such a long period of time is extremely neglectful.

After countless different dermatologists giving him different brands of topical steroids, Dr. Tavares was finally allergy tested 2 YEARS after first being seen. That is an obscene amount of time for a dermatologist to wait when the patient is not responding well to the steroid. It even says on topical steroid inserts that doctors should reassess the situation if it doesn’t get better (… not 2 years later).

After he had the allergy test, he found out he had an allergy to propylene glycol, which is commonly found in lotions, toothpaste and other body care products. By getting rid of products with this ingredient, he was fine. Or was he?…

No, he wasn’t. He had to withdrawal from the topical steroids that he had been using for so long because dermatologists didn’t take the time to properly diagnosis him. If they found the root cause to begin with, there would not have been any need for steroids.

And the biggest problem I find about this article is the emphasis they put on tapering, as if to say tapering solves all your problems. There are many Red Skin Syndrome sufferers who have tapered down, just as their doctors have prescribed, and still flare badly. Could it help with adrenal fatigue? Sure, I can see that if they need it for their adrenals. But to say they will be fine once they taper is not accurate.

“The doctor who diagnosed Tavares’ allergy says there’s no problem with the prescription of corticosteroids, but it is a mistake for patients to come off them cold turkey.”

Yes, yes there is a problem. No, I am not a doctor, but YES there is a problem. These topical steroids should not be prescribed for long periods of time, especially not on the face. It is not only neglectful but shows a lack of education on the topic of steroids.

So, I beg of you. If you have a rash come up, anywhere, get it tested (allergy and or swabbed for infection) before you start slathering on topical steroids as a solution. They are not meant for a long term solution.

Interview #5: Caroline Langdon

caroline-langdonCaroline Langdon

Adelaide, South Australia

“You are the sky. Everything else – it’s just the weather.” ― Pema Chödrön

1.When did you start using topical steroids? And why?

I was treated with steroid cream from infancy for atopic eczema.

 

2. What was the name of the topical steroid?

My mum thinks the first steroid cream was called Celestone.

3. Were you ever prescribed more potent steroids? 

Yes. All kinds. All strengths. For eczema.

As a young child I had severe eczema and was prescribed mild to strong steroid creams and ointments for different parts of my body. I think from around the age of twelve, I started using it on my face as I’d developed eczema there as well. Mostly around my eyes and mouth at that point. By the time I was a young adult I used steroid creams and ointments on and off, of varying potencies.  On my face and different parts of my body. By this time I knew steroids were not a great option long term and endeavoured to use them sparingly.

I tried all manner of things for managing my eczema naturally (without steroids), via nutrition, supplements, lifestyle, natural creams/potions etc…. but my skin would eventually become completely unmanageable after a few mths if not before. I would need to use steroids again to control my eczema, so that I was able to sleep, work, care for my children and function properly. They suppressed it, it worked temporarily/superficially, that is, until it didn’t. Such a vicious cycle.

4. How did you find out about RSS?

I typed into my computer something like: red, burning, severely itchy skin… and eventually stumbled onto ITSAN.

5. What made you feel you had RSS?

I was desperate to find out what was happening with my skin, it was not like the eczema of my past (though that was no walk in the park, this was much worse). It was often red, itching and burning. It didn’t matter how great my diet was or what else I tried, it kept getting worse and spreading to areas I’d never had eczema before. My asthma and hayfever were super bad on top of it. I’d always been an allergy prone person but I seemed to be allergic to everything! I was getting nowhere with the dermatologist I’d been seeing, except sicker and sicker. My skin was so unmanageable, it was affecting every facet of my life! He had me back on steroids telling me I had eczema urticaria and said, ‘Many people have to manage it with steroids the best they can the rest of their life, you’re not the only one!’ (I think this was meant to be comforting??). He put me on an immunosuppressant drug used for cancer and transplant recipients, which is what they give people with very bad skin conditions too I discovered but I agreed as was desperate.

My immune system was at such a low ebb, I felt so sick and run down and I had skin that was red, burning and incessantly itchy most of the day/night.

I indeed wanted relief but I didn’t want to be taking these drugs for the rest of my life, especially when I seemed to be getting progressively worse, not better!!

There had to be a better answer.

I was in such despair. I started googling my symptoms, things like ‘burning, red skin/ hives/ rash spreading to new areas/ relentless itching/ palpitations/ severe anxiety/ no sleep etc’ and found other people who described EXACTLY what I was experiencing and going through, the common thread having been the use of topical steroids.

Then I stumbled across ITSAN which was such a relief.

I had finally found a site and support group (so many people going through exactly the same thing as me!) that talked about Red Skin Syndrome.   The site linked many studies and medical publications about how Topical steroids can cause this condition in the body …..and people were finding a way to overcome it!!

Stop using them!! Ha, sounds easy right? Not so. If it were easy to stop them, I guess there wouldn’t be so many using them. Hardest thing I’ve ever done!! Also the best thing I’ve ever done!!

6. Were you diagnosed by a doctor? Did you have a supportive doctor?

No I wasn’t but my gp had seen me get progressively worse over time. When I told her that I believed it to be the steroids promoting the condition and shared info from ITSAN and others experiences with her, she found it to be very plausible, though she had never seen anybody else that was in the state I was in personally. She’s an Integrative Medicine GP so she was very supportive in monitoring me, etc. I don’t know what I would have done without her in those first 12 months, for moral support alone!

I had a great naturopath as well. Very lucky in this respect.

7. What were your first symptoms?

Spreading rashes, hives, red skin, burning sensation, crazy itchiness, sore eyes, poor sleep, heart palpitations, anxiety, depression.

8. Is your family supportive? Friends?

Yes, I’m so grateful to those who were/are.

I fell out of touch with many people though (or they with me). Mostly because I could no longer go out and socialise for quite a long time. It’s a very isolating experience in that sense.

9. Have you ever been to a hospital for this? 

In the early weeks of tsw, I was in a very severe state and had come up on the waiting list with the Dermatology Dept at the hospital.

After my previous experience with the dermatologist I wasn’t sure about going but was in such a bad way, thought I should keep the appointment because at that particular point, I felt like I was close to dying, no kidding! I had no idea how, or if the body could cope with this for much longer. Complete head to toe, burning, red, oozing and tremendous oedema. My face and entire body was filled with fluid and leaking it out everywhere at the same time. Nobody who knew me would have recognized me, I barely recognized myself. I walked in, in a knee length cotton night singlet, which was agony in itself. At home I couldn’t wear anything it was so painful. I looked like a maniac, itching insanely everywhere. The nurse at the counter got a cold, wet sheet and threw it over me, it was heaven for counteracting the heat in my body. By the time I was called in to see the dermatologist, I was shivering like crazy. I tried to explain that I had been reacting badly to steroid treatment and had ceased using any creams in the last few weeks.
They deemed me ‘critical’ and that I should be admitted immediately! I asked how they would treat me if this happened and they said with steroid wet wraps and oral cortisone.   I said that steroids were responsible for what had gotten me into this mess and so that was not an option really.

They basically said, ‘Oh well, if that’s not what you want we can’t help you today… but how do you think you will manage this by yourself at home’. I was gobsmacked, I thought they may have been able to provide some help or checking of vitals etc to make sure they weren’t sending me on my way if they were deeming me ‘critical’!

I said, ‘I don’t know, I guess I’ll go to my gp and get her to monitor me, make sure there is no infection, or something..’, to which they responded, ‘oh, your gp won’t be able to do anything for this’.

If you don’t want to be steroid tempted, hospital is not the place to go. I walked out and went home. It was truly the hardest yet best thing I could have ever done for myself.

10. What has been the hardest part of this condition?

The debilitating and painful nature of it, the fact that it unpredictably effects not only the skin but many aspects of the body’s internal and systemic functions. The continuous lack of sleep. The fact that it takes an undetermined length of time to recover from. Hmm, I guess there have been a few hard parts.

11. How long have you been in withdrawal? 

I’ve been in withdrawal since February 2014, so 33mths so far.

12. What do you use as comfort measures during this?

Tsw support groups have brought much comfort along the way.

Baths with Epsom and ACV (apple cider vinegar), icepacks, pressure bandaging, soft cotton clothes and bedding.

Sudocrem and Robertson’s skin repair ointment.

Meditation and drawing.

Good food.

Reading .

Many things but these are the staples.

13. Are you employed? Has this affected your job status?

I have been unemployed throughout tsw. Was unable to work and fortunate to be able to take time to repair my body. Have been doing some volunteer work but am only just recently beginning to seek work again. It’s been a financial drain of the highest order.

14. Have you gone to therapy/wish to go to therapy because of this condition?

Yes, I went to see a psychologist over the first 2 yrs. I found it to be really helpful in keeping me sane. Fortunately for me, he was very interested in nutrition and health, had a good comprehension of the impact prescriptive drugs can have on effecting body chemistry, health and well-being. It was an incredible support at a time when I really needed it, he provided good counselling space for me. He also used hypnotherapy in some sessions to help with pain and itch management. It made a dent.

15. If there is one thing you could say to another sufferer, what would it be?

The intensity subsides.

Time and perseverance definitely has its’ rewards, IT DOES GET BETTER!

Trust that your body has incredible ability to right itself.

Tsw is a lesson in loving patience, with oneself.

That was more like four!


Caroline, thank you! Such an in-depth interview!

Topical Steroid Label Part II

Class 1 steroids, like Clobetasol Propionate, will always be the ones you see in studies showing bigger problems than less potent classes. However, that does not mean less point steroids are super safe.

So, I looked up the insert for the steroid I used, Alclometasone Dipropionate, which is a Class 6 steroid (Classes range from 1-7, 1 being the highest).

“May be used in patients 1 year of age and older, although safety efficacy of drug use for longer than 3 weeks have not been established.”

Not…. been… established. That translates into “we don’t know anymore after 3 weeks.” Also, it should NOT be used in children under 1 year old (although my personal belief is to steer clear of steroids on newborn skin).

The insert says to apply 2-3 times daily. We still see wavering views on this subject, some research showing putting on steroids creams more than once a day does not increase the likelihood of it working, but actually just increases your chances of overusing. Source

“If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.” This doesn’t say “if this isn’t working we will just give you more potent steroids,” it states that there my need to be a reevaluation. Speak to your doctor about such matters because it is unbelievably important that you are diagnosed correctly. Perhaps you need a swab done to see if you have an infection? Or perhaps you are allergic to something inside the medication, or to a chemical or food you are use.

“In another study, Aclovate (alclometasone dipropionate) was applied to 80% of the body surface of a normal subjects twice daily for 21 days (3 weeks) with daily, 12 hour periods of whole body occlusion.” The HPA axis decreased 10% in these patients. This is a Class 6, mildly potent steroid, and within 3 weeks there was HPA axis suppression. First, 80% is almost full body, and some doctors will tell you to do that. Secondly, what is a normal subject? Someone with healthy skin? If so, someone with eczema will be even worse off since our skin barrier is damaged. Source

One of my favorite quotes is, “Topically applied Aclovate cream and ointment can be absorbed in sufficient amounts to produce systemic effects.” There is that word again: systemic. This Class 6, mildly potent steroid, can start affecting our adrenal glands. If a doctor says this isn’t true, hand them an insert.

This insert also says the same thing as Clobetasol Propionate regarding child toxicity and infection warnings. It also specified that it should not be used on diaper dermatitis.

“The following local adverse reactions have been reported…”

Who reports this? I never have. Where are these reports being made, or sent? Who sends them? Patients? Doctors? I know when I’ve stated adverse affects I’ve been told I was wrong by a doctor, so I know they weren’t reporting what I saw. I can only imagine that the list given is much smaller and/or incorrect due to lack of reporting.

But, check this out, you CAN do something: REPORT YOUR ADVERSE EFFECTS

Overall, there seems to be many unclear and unknown scientific facts about this steroid (most likely for all, but I can’t speak fairly on that since I have not read every single insert). Are we as patients supposed to be fine about this? When doctors tell us they are perfectly safe when we have concerns and see adverse affects, what evidence do they possess?

More research, management, and reporting must be done for the safety of patients.

Not Just A Dermatology Subject

Dermatologists are not the only ones allowed to prescribe topical steroids. Other persons whom prescribe these drugs are general practitioners, our family doctor. However, they are not specialized in this area. We already know some dermatologists push past the guidelines, but GPs are even less educated on steroids and all of their adverse effects if overprescribed or prescribed incorrectly.

In the FDA Evaluation and Research paper, they point out how our GPs can be truly hurting us. “… family physicians frequently prescribed betamethasone dipropionate and clotrimazole to children younger than 5 years of age and for use on genital skin disorders.”

Not only should this super potent steroid be prescribed with utmost caution to adults, but then add an anti-fungal (clotrimazole) into the mix, and you’ve got mega trouble. NEVER mix antifungals with topical steroids, and never use a steroid on a fungal infection. It is also stated in topical steroid inserts to never use these topical steroids on the genitals since it is extremely sensitive and most likely under occlusion (diaper).

This paper also talks heavily about research they constructed from 202 cases. The median age was 7 years old, a mix of both genders, and drum roll…. A median of topical steroid use for 169.3 days. That comes out to a little over 5.5 months of consecutive use. The shortest time was 1 day, and the longest was 7 years. This is why people have steroid phobia from this type of disregard for topical steroid guidelines.

If doctors wish to have the trust of their patient, then patients need to see that doctors can be trusted. We are the ones who have to endure the consequences. We are the ones who will have to suffer. There has to be open and honest communication on a level playing field. So many lives can be saved from needless pain if topical steroids were not only used strictly by a guideline (NOT by someone’s discretion), but also to know that the guideline set is correct and appropriate.

 

 

Feature #7: Paloma & Juli-Anne

paloma-macarioPaloma Rumsey

Age: 33

Career: Stay at home mom

When did you cease using topical steroids: November 5th 2015

What type did you use: Protopic (immnunosupressant) for about 10 years & triamcinolone acetonide for a few months

 What is your favorite product for comfort? I used a lot of Acquaphor, original brand of Walmart brand or RiteAid brand. Also bepanthen nappy cream

What is the hardest thing to deal with during this condition? Not being able to care or interact with my children and husband

What is the first thing you will do when healed? Take my babies for swimming classes and I will workout until I drip sweat


Juli-Anne Cowardjuli-anne-coward

Age: 49

Career: Artist and commended picture framer

When did you cease using topical steroids: 19th September 2016

What type did you use: Injected cortisone 6 months ( age 9), varyious topicals ranging from otc to most potent dermavate, betnovate, eumovate, hydrocortisone. Inhahled becotide, several courses of oral prednisone.

What is your favorite product for comfort? Dead Sea salt in the bath and sudo cream on the skin.

What is the hardest thing to deal with during this condition? There are many hard parts, not knowing how long, the intensity of pain, mentally crippling, all consuming. Not being understood by doctors .

What is the first thing you will do when healed? It is hard to say at the moment there will be lots of things I will look forward to I am sure one will be renovating our Spanish house,  but trying to help others and raise awareness of this disease

The Symptom Game

When you are sitting on your couch watching television, an advertisement may come up for a new drug. Pay attention when this happens. Listen to the commercial and take note of all the side effects that new drug may entail.

You decide you want to take that drug despite the risk. But, suddenly, you have two symptoms pop up. Your doctor says not to worry, there are drugs for those symptoms. Now, instead of one medication, you are taking three.

Then, one of your new medications is bringing on a side effect. Your doctor says don’t worry, there is a drug for that symptom. Now, instead of three medications, you are taking four.

This is how the world goes ’round. You went from one problem, to four.

Ever read the story about The Little Old Lady who Swallowed a Fly?

 

There was an Old Lady, who swallowed a fly.
But, I don’t know why, she swallowed the fly. 
Perhaps, she’ll die!
 
I know an Old Lady who swallowed a spider.
It wiggled and tickled and jiggled “inside her.
She swallowed the spider to catch “the fly.
But I don’t know why she swallowed the fly.
Perhaps, she’ll die!
 
I know an Old Lady who swallowed a bird.
How absurd – to swallow a bird!
She swallowed the bird to catch the spider
It wiggled and tickled and jiggled inside her.
She swallowed the spider to catch the fly. 
But I still don’t know why she swallowed the fly.
Perhaps, she’ll die!
 
I know an Old Lady who swallowed a cat.
Imagine that!  She swallowed a cat!
She swallowed the cat to catch the bird.
She swallowed the bird to catch the spider
It wiggled and tickled and jiggled inside her.
She swallowed the spider to catch the fly.
But I still don’t know why she swallowed the fly.
Perhaps, she’ll die!
 
I know an Old Lady who swallowed  a dog.
What a hog!  She swallowed a dog!
She swallowed a dog to catch the cat.
She swallowed the cat to catch the bird.
Swallowed the bird to catch the spider
It wiggled and tickled and jiggled inside her.
She swallowed the spider to catch the fly.
But I still don’t know why she swallowed the fly.
Perhaps, she’ll die!
 
I know an Old Lady who swallowed a goat.
It stuck in her throat, that silly old goat.
She swallowed the goat to catch the dog,
Swallowed the dog to catch the cat,
Swallowed the cat to catch the bird, 
Swallowed the bird to catch the spider 
It wiggled and tickled and jiggled inside her.
She swallowed the spider to catch the fly.
But I still don’t know why she swallowed the fly.
Perhaps, she’ll die!
 
I know an Old Lady who swallowed a cow.
I don’t know how she swallowed a cow.
But, she swallowed the cow to catch the goat,
Swallowed the goat to catch the dog,
Swallowed the dog to catch the cat,
Swallowed the cat to catch the bird,
Swallowed the bird to catch the spider
It wiggled and tickled and jiggled inside her.
She swallowed the spider to catch the fly.
But I still don’t know why she swallowed the fly.
Perhaps, she’ll die!
 
I know an Old Lady who swallowed a horse.
She’s DEAD, of course!

-Recorded by Dr. Mike Lockett 

 

Down the rabbit hole, further and further. Always weigh out if your first initial problem is worth potentially incurring many, many others.