Thursday, May 30, 2013

Turns out Protopic and Elidel carry no cancer risk

If you’ve ever considered using Protopic or Elidel as an alternative to steroids, you, like me, will have been taken aback by the FDA’s black-box warning that these drugs theoretically could increase your risk of getting cancer. (In the US, there's an actual black box on the packaging, somewhat more prominent than the warning on cigarette packs.)

A new, well-written report debunks this claim thoroughly.

Written by two researchers at Saint Louis University in Missouri and UT Medical School in Texas and a science writer in Chicago, and published in the American Journal of Clinical Dermatology, the paper points out that the FDA’s 2005 advisory was based on three justifications: extensive off-label use to treat children under two years old; a very small number of adverse drug reports (two for Elidel and five for Protopic); and a study done in monkeys in which the animals were given much larger doses than would be typical for human patients.

Now, eight years after the first FDA warnings appeared, the authors say that use of these creams has not been shown to increase a patient’s risk of developing any type of cancer.

Elidel (pimecrolimus) and Protopic (tacrolimus) are “calcineurin inhibitors” formulated as creams. They reduce the levels of pro-inflammatory molecules produced by T cells. With all immune-suppressant drugs there is always a possibility that the drug will prevent the body from destroying cells that have become malignant. But Elidel and Protopic do not raise the risk above the background level.

Unlike topical steroids, calcineurin inhibitors do not thin the skin, and patients who use them apparently do not experience a “rebound” effect in which the eczema returns after drug use stops, as is the case with steroids.

According to a graph in the report, Elidel sales are now much lower than they were in 2005, while Protopic sales have recovered to their original levels.

This matters because calcineurin inhibitors are a valuable alternative to steroids—for some, at least. When I tried Elidel, it did nothing for me, and Protopic gave me an intense burning sensation and a terrible headache.

So if you have been putting off using these drugs for fear they might cause cancer—now’s the time to give them a try!

20 comments:

  1. Yes, Protopic and Elidel has been prescribed by dermatologists, and largely without worry of cancer risks as I think in their derm gatherings/ forums, this has been discussed and various studies shared gave derm the confidence to prescribe without worrying about cancer.

    Cheers!
    Mei

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  2. Thanks Mei--I admit I do feel weird about Protopic since it was such a bizarre experience for me--to rub some cream into the crook of your elbow and suddenly have a blinding headache. It gave me a new respect for the power and danger of pharma.

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  3. I was prescribed Protopic recently by my dermatologist for pretty bad eczema on my face. Have always had eczema since childhood, usually not too severe, but never on my face before. I am 50, male. The protopic worked very well. By the 4th day, aside from some redness, all the blemishes and eczema was gone. Side effects are severe itching (the first few applications) and severe pain if I scratch the areas where I've applied the ointment. However, my problem is that when I stop applying the ointment - the eczema gradually comes back. It flares up. I'm going to try to use it for a few days longer than last time, and then "maintenance" for a few times/week, to see if that keeps it at bay. As for the cancer risk - I don't know what to make of it. Who do we trust?

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  4. I've suffered from eczema since childhood and Pimecrolimus completely eradicated the severe eczema lesions behind my knees. While I still have a few spots that pop up during the winter, Pimecrolimus keeps it controlled. Very effective cream, just very pricey.

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  5. I've suffered from eczema for a long time and when I was in my late teens I took both Elidel and Protopic for an extended period of time. Fifteen months after stopping the regimen I was diagnosed with stage IIB Hodgkin's Lymphoma. I went through 6 rounds of chemo and have also developed melanoma in situ. I know that many people will say that it's just a coincidence or bad luck but I beg to differ. Don't get me wrong I don't think that everyone who takes these drugs is going to develop cancer, and I think genetics has a big thing to do with it but is it really worth the risk??? I was treating severe eczema and ended up with CANCER! If someone would have told me the risks were REAL I would have thought twice. Hope this helps someone else. I was diagnosed at 22 and now live my life with the constant worry of a reoccurrence.

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    Replies
    1. Beth, I am so sorry about what happened to you. I have been debating treating my 4 year old daughter's eyelids with elidel, but your post made me make the decision not to. I have come back to re-read your post and I have a question: did you take the medication internally or topically? for how long? did you get melanoma at the site of application? Thank you very much.

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    2. The creams are for cosmetic purpose and are only to be used 2weeks at a time. A person's diet plays a big part with the out breaks as well as other factors...My son has eczema as well and he did use those creams when he was younger but I also used natural remedies to maintain his skin along with a clean diet... He is now 11 yrs old and have not had an outbreak in over 5yrs.

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    3. Hello Mr or Ms Unknown. Which diet is your son eating that made it possible for him to not have an outbreak for over 5 years?

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  6. Today is my first day using protopic 0.01% cream on my face and it is burning, hot and itchy on my face. This has been going on for 2 hours now and i can tell if its a side effect or if its irritating my face.. How long/ how do you know if I should stop this or not?

    And it says do not apply to infected areas. I have a patch that has a bit of water coming out (ooze?) And when it dries its yellow. Does that mean its infected? I applied protopic to it..what happens if I applied it to an infected area?? :'(
    Help!

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  7. Clear fluid sounds more like lymph fluid to me from broken skin rather than infected, but who knows, should get a dr's advice. I have only just found out about risks associated with elidel which is quite disturbing as a dr prescribed it for my daughter when she was only 6 mths old (now 9). The cream worked although fortunately did not on my sons and so I did not continue use. I now only use gaiya ointment. A native bee farmer developed it from the wax and propolis. You can get it by contacting through their website nativebees.com.au. It works better ( on my children) than anything else and because it is natural it does not matter how much, how often or for how long I use it. I can understand why people take risks with products as the effects of eczema can make you desperate for relief. Just so glad I have found a better alternative. Good luck!

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  8. I have had embarrassing eczema all over my face and since I couldn't use steroid creams on my cheeks I started using Elidel and it has changed my life! I've been using elidel on and off for 3 years now and I have had no problems at all. My skin clears in 2 days max and I'm so grateful. The key is to apply very little and dilute it by putting vanicream over it. Serious life changer right here:)

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  9. I have had Perioral Dermatitis since April, I have been prescribed Topicort, Elocom and Metrogel. None of those 3 worked on me, it only made it worse!! My face is so embarrassing that I don't want to leave my house. I finally was able to see a Dermatologist and he presribed to me Protopic, I read about it and it says that it may cause Skin Cancer or Lymphoma so that definitely worries me. I'm questioning on whether to even use it or not, I've been given 3 prescription and none of those 3 have worked and now I have Protopic but using that worries me. Ahhhhh ...

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    Replies
    1. I have perioral dermatitis from using a cosmetic product. After 4 months of absolutely nothing working my dermatologist prescribed me Elidel and after 2 days of using it once a day the dermatitis almost completely gone. I'm completely floored at quickly I've seen results. But hopefully it stays away once I stop using it.

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    2. I have perioral dermatitis from using a cosmetic product. After 4 months of absolutely nothing working my dermatologist prescribed me Elidel and after 2 days of using it once a day the dermatitis almost completely gone. I'm completely floored at quickly I've seen results. But hopefully it stays away once I stop using it.

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  11. I have extreme eczema mostly on my face and chest. My eyelids are the worst. Flaky skin, I basically look like a burn victim. Hydrocortisone, Elocom and all them steroids made it better for a couple of hours, then I ended up looking even worst than before. I was prescribed protopic at some stage, but it gave me severe burning and redness, so I quit using it. Recently my GP and consultant mentioned it again, so I decided to give it another go. Im on predniselone 40mg now started to reduce. It stopped the eczema spreading, but didn't heal it, it didn't go away. Anyway to cut it short. I applied the protopic and for 24 hrs I had the burning again, my head was constantly red, basically I looked like I did before the steroids. I had hot flushes, I even woke up at night as it was burning like hell.. I had headaches, and felt like a bit on drugs, my head just didn't feel right. These symptoms gradually reduced within 3 days. My skin never looked so beautiful, I can't wait to look in the mirror in the morning - I always avoided mirrors :) Fingers crossed it will be a long term solution for me. Im fed up spending 100£ every month on new drugs and natural remedies, which won't work (I tried everything under the Internet, from all over the World). Im a female, 33 yrs, atopic dermatitis since birth. As for the cancer scare, I rather go with protopic than with steroids.

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  12. These creams cause Red Skin Syndrome. So do all the cortisone creams. The withdrawal is hell, but true healing comes after withdrawal.

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  13. I use protopic as prescribed from my Doctor for insect bites. However when I stopped using it tiny spots came back . I do not need this as I work in the public sector this is a nuisance. I heard about Neem Leaves boil them then let it cool down strain the water into a bottle use cotton ball dip into water then face skin or affected area no side effects. Also wonder if a good astringent would do the trick once skin clear & never use protopic again? I do not need skin problems recurring I am 51 years old and this is truly embarrassing. The cancer scare has me concerned.
    Also heard of Vitamins & foods that fight acne & infection , I do not wish to depend on nasty antibiotics the rest of my life. What about blood purifying foods ? I do not need these nasty side effects If there is any Naturopath out there that would like to give advice , I would be very thankful.

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