FDA warning re: eczema medication

[laurasnowbird]

I know lots of our kids have skin issues, and some may have eczema and use this medication, so I wanted to share this info:

"WASHINGTON, March 10 (Reuters) - Two eczema creams, Elidel and Protopic, should carry a strong advisory about a cancer risk, the U.S. Food and Drug Administration said on Thursday in a warning strongly disputed by the manufacturers.

Research shows the creams are absorbed into the body and may have the potential to cause cancer, the FDA said. It was working on a "black box" warning for the salves -- the strongest warning carried on medicines.

And babies should not be treated with the creams at all, the FDA said.

But Novartis AG , which makes Elidel, disputed the FDA's call for a black box warning and said there would be no change in its label for the time being. Fujisawa Healthcare Inc. which makes Protopic, also said its product is safe.

"FDA has informed Novartis that we will begin discussions about the type of label and the exact wording contained in the label within the next few weeks. There is no change in the label at this time," Novartis said in a statement

And the American Academy of Dermatology, which represents skin specialists, also questioned the move.

"Because these medications are applied to the skin, virtually none of it gets inside the body," dermatologist Dr. Clay thingyerell, president of the academy, said in a statement.

"These are valuable medications, and if used properly, they significantly reduce the debilitating impact of eczema and allow millions of our patients to live normal lives."

The FDA usually negotiates changes in drug labeling with the makers. But the agency has been under fire from consumer groups and Congress, which question whether the agency does enough to monitor the side-effects of medications after they are approved for the market

COMPANY SAYS CREAM SAFE

"Novartis agrees that patients suffering from mild-to-moderate eczema need to be informed about the safe and effective use of Elidel, but we believe a recommendation to add a black box warning to the label is unsubstantiated by clinical evidence and experience in more than five million patients worldwide," the company said.

The FDA said animal studies showed a link with cancer. Tests of whether an agent can cause cancer are done on animals, because it would be unethical to experiment on humans.

"The data showed that the risk of cancer increased as the amount of the drug given increased. The data also included a small number of reports of cancers in children and adults treated with Elidel or Protopic," the FDA said in a statement.

These included seven cases of lymphoma and six skin cancer cases.

In February, members of an FDA advisory panel said they were concerned the companies were aggressively advertising the medicines to treat infants and others with skin problems that the creams are not approved to treat.

Elidel, known generically as pimecrolimus, and Protopic, known generically as tacrolimus, should be used only as directed and only after other eczema treatments have failed to work because of the risk, the FDA said.

"Both products are applied to the skin to control eczema by suppressing the immune system." the agency added. Suppressing the immune system is known to potentially contribute to cancer.

Doctors who prescribe the drugs should remember they should be used only for the shortest time possible, the FDA said.

"Elidel and Protopic are not approved for use in children younger than 2 years old," the FDA added.

Novartis stock closed down 12 cents at $48.70 on the New York Stock Exchange on Thursday. (Additional reporting by Lisa Richwine)"

[daniellebrinbeauty]

Laura,

I am sooooo glad you posted this. I used to belong to this board two years ago shortyly after my beautiful daughter was born. Anyway, I recently submitted her for a study at a local dermatologist for a new cream relating to dermatitus or eczema. We were denied because of the DS diagnosis. This really ruffled my feathers as Dani is perfectly healthy with NO health issues at all. I asked them how they can market it to a special needs audience when it becomes available if they are not allowed to test it on them.

Their response " It is rather, the decision of the pharmaceutical company medical monitor, guided by an FDA approved study protocol, to exclude anyone with a medical condition (i.e. fragile diabetics, certain heart conditions, various immune disorders, etc…) which could be jeopardized by the use of an investigational drug.

So it got me thinking that I as a mother and a consumer am blindly accepting advice and treatments2 without checking to see if they have been tested on a wider audience other than the typically developing individual. I responded by also saying that I hope they DO put a disclaimer on their packaging since the product has not been tested on individuals with "fragile" conditions. I won't get started on my letter but I am glad to see your post on the products.

I have been using Cetaphil on Dani and she is responding well to it. And I am definately not interested in her being in the study any longer since the cream going into the blood stream can be harmful based upon your post.

I just thought this was timely.

Oh, by the way congrats on your new little one.

I used to post a lot and left but am checking back from time to time.

Kim ( mom to beautiful Danielle Brin-27 months)

[Alice]

Laura,
Who approved that product at first? FDA?

[meghans_mom]

Alice, yes - the FDA has to approve all medications before they hit the market...atleast prescription medications. Not all over the counter things are FDA approved.

Laura - I rec'd the same warning today in an email...I have winter eczema and DH has either psoriasis or eczema - he hasn't seen a doc yet for it, but I was sure they'd give us both one of these medications. scary stuff.
Even scarier is the doctor stating: ""Because these medications are applied to the skin, virtually none of it gets inside the body," dermatologist Dr. Clay thingyerell, president of the academy, said in a statement."
I don't know if that is true for those medications but that's sooooo not true! Especially if the skin is thinner or broken, absorbtion can be greatly increased with other topical creams/ointments, like steroids.

laurie

[Jessie]

So . . . these creams are designed to suppress the immune system, yet not much gets into your system? Isn't that kind of a contradiction?

I wonder what that ingredient/chemical in those two particular creams have that is causing that side effect? Or, is it a class of cream itself that is potentially dangerous and there might be other creams that will be added to that list?

I have Psoriatic Arthritis (ok, weird kind of arthritis!) and used to use a cream called Elocon that worked really well. I now get injections twice a week of Enbrel and that in itself has cleared up any psoriasis I used to have. By the way, I have noticed that they are advertising Enbrel for moderate to severe psoriasis as well as advertising it for arthritis. Enbrel is a miracle drug!! The ads that you see on TV where they show people living these fully functioning, fun lives who have moderate to severe arthritis is no lie!! Both me and my mom are on the injections and we feel back to normal now and neither one of us have psoriasis.

Anyway, just wanted to throw my 2 cents in on recommending Elocon cream.


Jessie

[Kristen]

Nice. I have slathered myself with more than one or two tubes worth.

[meghans_mom]

Jessie - I'm just guessing but it's the class in general that is potentially dangerous.
Most creams use similar bases (or vehicles) in which to hold the active ingredients...a mixture of different non-active ingredients (glycerin, propylene glycol, etc)...

if you look at the generic names:
Elidel, known generically as pimecrolimus, and Protopic, known generically as tacrolimus
you'll see they're both in the same class with the suffix -limus.
To my knowledge those are the only 2 drugs in that class on the market so I doubt anything will be added to the list. (my uneduated guess, lol)
laurie

[laurasnowbird]

Laurie,

You uneducated guess my foot, LOL! I hope you are right (and I suspect that you are) that no others will be added to the list. I have a friend whose child was under two and used Elidel, so reading this article was rather upsetting.

It is getting harder and harder to trust the FDA these days. I know they are under tremendous pressure to get new drugs to market, but it seems that political forces are coming into play on some of these drugs and that never benefits the consumer. It is disturbing to read some of the information in the news lately regarding conflict of interest relative to the people who are doing the studies. Yikes!

[Alice]

FDA should be call off some day for being useless!
It is a group of idiots who approve medications for being paid... a lot.
I do not trust that FDA - so many bad mistakes, so many lies, so many people are hurted... or even dead...

[meghans_mom]

Yeah, Alice - I think sometimes the FDA as a whole stinks but just think of it....if there were no FDA or regulatory agency - ANYONE could market any type of treatment they wanted. And a ton of very harmful things that the FDA turned down could very well be on the market right now and that would be a whole lot more dangerous.
laurie

[Cbean]

Just wanted to mention that I spoke with our pediatrician and he stands by the medication. Anyone else ask their's?

[Alice]

I would not ask pediatricians, because most of them are sales people for FDA.

[laurasnowbird]

Alice,

ROTFL!

I hope it's not quite that bad, but I don't think a busy doctor has the time to check out every new medication, and has to be able to rely upon the representations and judgement of the FDA. That seems to be where the problem truly lies. The FDA needs to work to restore its reputation and get back to the business of protecting the American people.

My pediatrician said he will stop recommending it, unless he has an extreme case that nothing else has worked for. In that instance though, he intends to make the parents fully aware of the risk, and let them make the final determination whether or not to use it.