Welcome to the EczemaVoice discussion forum. Since 2000 we have tried to keep the forum open so that you do not have to register. However due to increasing amounts of spam we have now reluctantly taken the decision to require users to register first. We hope you understand, thank you.

Warning to Protopic and Elidel Users

Warning to Protopic and Elidel Users

Postby mookiie » Sat Feb 19, 2005 7:59 pm

I recently received an email from food and allergy network stating that the United States FDA had issued a warning that Protopic and Elidel increases the risk of developing certain cancers to its' users particularly on children. I called the companies and confirmed that the warnings were indeed true. I also surfed the net to gather more informations on the matter.

Both of my kids, ages 2 and 4, have both been born with eczema and severe food allergies. Our lives have been totally up side down because of their condition....physically, emotionally and mentally we were drained.

Like most of you in this forum, we've tried almost everything that is out there to treat my childrens' eczema, from moisturizers, steroids, antibiotics and alot more.

My oldest son was introduced to Protopic when he turned 2 because he was poorly responding to steroids both oral and topical. With these steroids my sons' eczema would really clear up, but once i stop using it the eczema would come back even worse.."rebound phenomenon". There's a time limit on the usage of these steroids so we were prescribed to use Protopic. Eversince my son used it, he has been cleared of his eczema.Though once in a while he still gets some on his feet and fingers. That's why it has been prescribed to my young one because of the improvements it made on my son.

Protopic have REALLY CHANGED our lives. Both of my kids are sleeping throughout the night. Their eczema has been under control.

I was totally shocked to hear the news about the FDA warning because my kids have been on Protopic for a really long time now, more than a year, and they're using the strongest strength .1%. I stopped using the medication on my kids and switched back to over the counter steroids. I know steroids have also side effects but not as grave as that of Protopic..Cancer is Cancer. Even though Protopic have made a big difference in our lives I wouldn't compromise my kids health and future.

I don't know what would happen now that I switched back to over the counter steroids. I'm still waiting for my kids dermatologist to call me up because they're in a convention for a week.
mookiie
 

Re: Warning to Protopic and Elidel Users

Postby ruth » Sun Feb 20, 2005 2:27 am

mookiie - one of the biggest problems that parents/sufferers face is that they are not well informed about these medications when they are prescribed them. This is not the fault of the individual themselves - but of the prescriber. I really wish docs would take the time out to describe the mechanism of how eczema happens and how the medications work. It would take away a lot of the fear that people have about these drugs thereby giving them more confidence and ability to be able to be in control of their condition. What you are describing is a classic reaction to how this whole system has failed you - it is quite reasonable to feel the fear that you are experiencing because I am sure you were never aware of these potential side effects or they were never probably explained to you.
What I can tell you is how these medications work and I would STRONGLY suggest for your own peace of mind is that you really bombard your doctor and your pharmacist ASAP to explain to you in laymans terms how these drugs and eczema work - it is your right to know - and you will feel much better if you have a good understanding of this. Its a case of getting to know the demon within your body so you can effectively battle it with the right equipment.

Protopic and Elidel all belong specifically to a class of drugs which suppress a key stage of the immune response. These are known as the topical immunosuppressants. Because eczema is caused by an over-reactive immune response in the skin that causes inflammation and tissue injury - as shown by different levels of tissue destruction e.g. dry irritated skin, broken bleeding weeping skin etc. - this is why these drugs can be particularly useful- because they directly dampen down this over-reactive immune response and help to return the skin back to what should be its 'normal' level of functioning. These drugs only act locally - i.e. at the site of application so they are not absorbed into the bloodstream to affect other parts of the body. So they are good because their effect is localised, doesn't causes systemic effects in other parts of the body.
This then brings me up to the point of concern you have raised - in relation to CANCER. Because these drugs locally reduce the immune system within the skin where they are applied - and the immune system can help to destroy cancerous cells - the obvious connection here is that by using these medications - you are going to increase your risk of potential skin cancers. You need to use sunscreen protection (as you should in any case regardless of whether on/off these meds)- but at this stage, there is no evidence to suggest that it does in fact CAUSE cancer - and this is where the importance of discussing this with your doctor & pharmacist comes in. I have researched this myself as have also gone down this road ( I am a registered nurse and have researched a lot of the medical journals plus spoken at length about this with our consultants - I'm not claiming to be an expert at all - but I understand the fear you have about this - I have had this too). I am satisfied from what i have read/researched/seen etc etc that these drugs are in fact relatively safe drugs to use - they have a high safety profile and are predicted to actually take over/match steroid use in the future.
Don't fall into the trap of thinking the steroids are 'safe' either. They also act by suppressing the immune response in the skin - JUST AS MUCH!!plus have other potential side effects e.g. skin thinning etc. You still should wear sunscreen if you are going out when you have applied steroid preparations.
What you have to realise is that every drug has a potential side effect profile - it doesn't mean that you are going to get or experience ANY of these - but the manufacturers have to list them in any case. Obviously - a product which is going to suppress the immune response/system - MUST have listed as a potential side effect that horrible c word CANCER. It doesnt mean that you are going to get it or give it to someone by using it - its just to say that it might or has the potential to happen. If you read the potential side effect profile on a drug like paracetomol (Panadol) you would be absolutely horrified e.g. potential to cause liver damage/failure etc etc - but we take these drugs without ever thinking that this could happen to us - because the reason why we are taking them is for the PROVEN BENEFITS that they can offer us.
You need to get a realistic appraisal and grip on the actual risks of using these medications.
It might sound weird - but they actually use immunosuppressants as part of treatment for some cancers e.g. leukemia.
Discuss your concerns with your dermatologist - get better informed by them. Protopic like you say has changed so many lives for the better- I would hate for you to let it go as a treatment option because noone has explained it to you. All the best.......sorry for the long post
ruth
 

Re: Warning to Protopic and Elidel Users

Postby Zagreb » Thu Mar 10, 2005 3:35 pm

mookiie,
could you please give me the link to the web site of the food and allergy network, cause I was trying to find this informations about Protopic and Elidel on FDAs site and could not find any warnings. My dermatologist claimes that they are safe and recomends using Protopic, but I am concerned cause I live in Croatia (Europe) and am afraid that maybe he has less information than he sholud, so I would not like to put my 3 years daughter on some therapy that may harm her.
Thanks a lot,
mum from Zagreb
Zagreb
 

Re: Warning to Protopic and Elidel Users

Postby Adrienne » Fri Mar 11, 2005 10:15 pm

Hi there...

I was just posting on the Mothers Talk board and then I noticed your discussion here. I just heard about the cancer risk yesterday and I don't know what to do either. Protopic has been such a miracle for my 1 year old daughter's eczema, but of course the cancer risk is frightening. Here's a link to the FDA warning:
http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01343.html
Adrienne
 

Re: Warning to Protopic and Elidel Users

Postby H » Fri Aug 05, 2005 11:16 am

Hi all , I am wondering how many people are still using protopic after the warnings? I stopped using it on our daughter and now her skin is worse than ever, after three years of it being under control it is now back to antibiotics and steriods. A choice of two evils really.Was just wondering how every one else is getting on.
H
 

Re: Warning to Protopic and Elidel Users

Postby ruth » Sat Aug 06, 2005 9:26 am

hi H - yes i've been wondering the same thing too - it seems as if the FDA has just left everyone hanging in mid air and no-one is sure really what to do. i think that you should perhaps hound your gp/dermatologist/specialist for answers on this matter to see if anything further has come to light - if they don't know then ask them to find out for you. no treatment is without risk - and the issue of increasing risk of cancer with any form of immunosuppressant medication - whether topical (steroids/protopic/elidel) or systemic needs to be properly researched and communicated effectively to the public. it may well be that they don't have the answers at this stage - but a realistic appraisal or indication of the level of risk needs to be publicised so that those using these medications can make an informed decision
ruth
 

Re: Warning to Protopic and Elidel Users

Postby Gavin » Wed Aug 06, 2008 8:21 am

Hi all, just a couple of things I wanted to mention. My dermatologist in Sydney, Australia said that the 'official warning' does NOT exist in UK, Europe or Australia, , but only exists in the US. That may be of interest to some people. In other words it's not a 'black and white' factual conclusion, but rather some scientists believe it enough to put in place an official warning, others don't.

Having said that, I have my doubts about Tacrolimus, and would like to share my experience. I am 30yo, have been a chronic Eczema sufferer all my life. It prevents me from living my life how I'd like to, and it causes me a lot of anguish.

I'd just like to point out that I got put onto Tacrolimus about 4 years or so ago, when it first became available in Australia. When I first started using it, it was fantastic. Seemed to work perfectly. However, having used it for a number of years, I'd just like to state this. The area where I used tacrolimus (face and neck), is now almost always bright red. If I get any sun exposure whatsoever, it goes bright red. If i have any source of heat whatsoever, it goes bright red. Under any flurescent light (shopping center, office, home), it looks bright red. If I drink ANY amount of alcohol whatsoever, it goes BRIGHT red (This one I find very harsh - I can't even have a small drink over christmas with the family) It goes so red, that I can't even be in public.

The area that I used this cream, is now more problematic than any other skin on my body. I don't know what Tacrolimus has done, but it scares me. When it says "stay out of direct sunlight", I think you MUST heed the warning. It means, if you don't stay out of ANY direct sunlight, there will be permanent irreversable damage for life. And realistically, in my opinion, it is absolutely ABSURD to expect people to get no sunlight.

I'm not saying not to use Tacrolimus. Many dermatologists say, as with steroid creams, its the better alternative to no treatment at all.

I'm just saying be aware, be careful.
Gavin
 

Re: Warning to Protopic and Elidel Users

Postby MH » Fri Apr 03, 2009 10:55 pm

Gavin,
I have actually had the same experience with Protopic, and I don't even have eczema. I was prescribed the medication for some temporary dryness on my face. It was a complete overkill for my condition and now I'm stuck with very similar symptoms, which have been described by my GP as "rosacea like". I have found one natural product that provides some relief. I have been using it for about a year now and although the problem is not completely eliminated it is a significant improvement. Here is some info:

dermamed.com/product_details/natural_skin_care/dmrosa_cream/default.asp

This company also provides natural products for eczema and other conditions. I'll be curious to know if it helps you, or maybe you found something else that works?

I also agree and advice everyone. Beware of Protopic or Elidel. Use it if you absolutely have to but avoid it if you can!
MH
 

Re: Warning to Protopic and Elidel Users

Postby very satisfied! » Wed Dec 08, 2010 3:45 pm

Protopic works REALLY WELL. Cleared up about 75% of my rashes (on my forehead and eyebrows) within 3 to 4 hours of putting it on
very satisfied!
 

Re: Warning to Protopic and Elidel Users

Postby L » Thu Dec 22, 2011 5:55 pm

Does anyone know how much of Protopic and/or Elidel is absorbed through adult skin ( i.e. achieving systemic levels) in various areas of application. I suspect in the hands it is less so, but in certain sensitive areas, more so. I have heard differing opinions on whether these products suppress the immune system to any degree with short term use.
L
 


Return to Tacrolimus/Protopic

Who is online

Users browsing this forum: No registered users and 2 guests

cron