Is anyone else concerned that the Elidel findings may apply to Xolair for PA???

I posted at least a year ago that dd`s allergist told me that the anti IGE may be linked to cancer. I think it was skin cancers. Dd`s allergist said for that reason that when it was available for pa that he would only want dd to have it during temporary situations that are high risk such as going away to camp. This was right before the studies got halted on the Tanox anti IGE.

I recently posted an article about Elidel under Off Topic, only because I didn't know where it should be posted....no one replied or responded. I just assumed no one cared.

Here is my original post:

Here is an article that was posted on another site. Some of the members on the other board spoke with their pediatricians today. They made it clear that some of the facts were not included in the article including that the dosage used on the monkeys were MUCH larger than those on humans. I guess it is a personal decision about whether to stop using it or not.?.

Cancer Warning Suggested for Eczema Creams: Expert Panel Recommends "Black Box" Warning for Elidel, Protopic

By Colette Bouchez

Reviewed By Michael Smith, MD

Feb. 16, 2005 --WebMD Medical News-- Two relatively new and very popular prescription creams used to treat eczema in children and adults may soon carry a "black box" warning -- indicating the drugs represent a cancer risk for some.

In an FDA meeting, a distinguished nationwide panel of experts reviewed medical data that linked Elidel and Protopic with an increased risk of skin cancer and lymphoma.

Their recommendation: That both medications carry a warning that the drugs may increase the risk of cancer. They continue to back the original FDA ruling that the drugs should not be used in children under the age of 2.

"We made our recommendation based on animal data and biologic plausibility combined with the fact that the use of these products is increasing tremendously," says Dianne Murphy, MD, committee member and FDA director of the Office of Pediatric Therapeutics.

Both drugs are currently approved for the treatment of eczema, an inflammatory condition of the skin which affects some 15 million Americans, 20% of whom are children. The condition causes dry, red, itchy skin that can blister or develop scaly patches.

The majority of patients develop their first bout of eczema before they are 12 months old. Both Elidel and Protopic are currently approved for use in children aged 2 and up.

While the FDA committee recommends a stern warning for all those who use the drug, Murphy stresses that there were no human clinical trials that indicated cancer was a risk.

However, she tells WebMD that the committee reviewed numerous animal studies that did indicate a risk, including one monkey study that showed an increasing risk of developing tumors as doses increased.

"The greater the dose the greater the number of tumors -- and with the highest dose we saw seven out of eight monkeys develop tumors," says Murphy.

Equally important was the "biologic plausibility of the drugs" -- meaning, the way in which the medications work. These medications suppress the immune system, which may be a precipitating factor in the development of cancer.

"It depends greatly on what other precipitating factors may be present in an individual patient's profile, but this could certainly be a contributing factor under certain circumstances," says Murphy.

Adding more fuel to the fire was a series of isolated adverse events voluntarily reported by consumers and their doctors to the FDA.

Since Protopic was approved in 2000, the FDA has received 10 reports of serious adverse events in children under age 2, and 17 cancers in all age groups. These included non-Hodgkin's lymphoma and skin cancer. Published reports say three of these cancer patients have died.

Elidel, which was approved in 2001, appears to have a similar profile. According to FDA records, from approval in December 2001 through September 2004, there were 54 serious adverse events reported in children under the age of 2, and eight cancers in all age groups, including four in children over the age of 2. The majority of the noncancer events were skin related, and resulted in hospitalization for 15 children.

Creams Used When Steroids Fail

While the number of tumors detected is significant, experts point out it is still small compared with the millions of people using these medications. According to the FDA, nearly 9 million prescriptions were written for Elidel since its approval, with 12.7% prescribed for children between 1 and 2 years old. Although Protopic was on the market sooner, prescriptions for this drug climbed to just 3.5 million, with about 8% given to younger patients, says the FDA.

Other drugs used to treat eczema include steroid medications, which are normally the initial treatment. Experts say both Elidel and Protopic are considered second-string drugs, recommended only when steroid medications fail.

If you are currently using either Protopic or Elidel, Murphy says be certain you are using them only for the conditions for which they have been approved, and only if there are no other treatment options. Experts also say you should talk to your doctor about whether or not you are at increased risk for cancer due to other precipitating factors, including personal and family history of disease.

The FDA is expected to rule on the "black box" warning soon, though it is likely they will take the committee's recommendation.

Published reports indicate both drug manufacturers say there is no clinical evidence of increased cancer risk in humans with either medication. Both companies agree monitoring should continue. Published reports say the companies also plan to review safety data and are planning to continue studies on their own.

We don't use this but I know others that do.
Thx for posting

I have been researching Xolair quite a bit lately because my son's allergist thinks he would be a great candidate to use it...if only it was approved for children. He has a severe pa...severe enough that he reacts to residue, airborne and often times has major reactions and we can't even find the source of the reaction. His IGE levels are very high and we are getting to the point where we don't know what to do. We only feel safe at home and that is not possible because he needs to start school in the fall...

Anyway, there was an extensive post on this Board about the connection between Xolair and cancer...I can't seem to find it at the moment, but I read it last week, if anyone else can link the thread that would be great.

I guess I am getting to the point that my son cannot function normally right now, we just pray that Xolair (or any other medicine) would help him, without great risk.

If I did this right...here is the link, lots of information not directly related, but towards the end of the post there is some information. Hope it works!

[url="http://uumor.pair.com/nutalle2/peanutallergy/Forum1/HTML/004743.html"]http://uumor.pair.com/nutalle2/peanutallergy/Forum1/HTML/004743.html[/url]

I tried Protopic and Elidel for my son when they first came out for a short time. They did not work well for my child and I haven't used them since.
I had a policy to never ever accept a prescription for a drug less than 5 years on the market for my son. (for this reason).
I broke the rule in this case since it seemed less threatening than a pill or ingested med. I continue to hold this stand and will include creams in the future.

Quote:Originally posted by saknjmom:
[b]
I had a policy to never ever accept a prescription for a drug less than 5 years on the market for my son. (for this reason). [/b]

That is a good policy! It makes me angry, because my DD's allergist gave us free samples and a prescription BECAUSE this was safer than a steroid cream. Or so he said. Everything I've read now says it is to be used only of steroid creams don't work.

Didn't work for us either though and we used very, very little of it.

Carolyn

Im tired of hearing elidel stories, which is maybe why I didnt respond to the OP.

No. Not tired of reading them. But I know the consequences of the drug... have read about it for mths now.. NOW the FDA comes out and says it...

Well... do I believe them? I don't want to think about it.

We've been using Elidel a LOT for <4> yrs now. Yes. 4.

We were in a pre-FDA approval clinical study for it.

It worked VERY well for Caitlin. VERY well.

Im not thinking about her future right now... Im MORE concerned with keeping her alive now, kwim?

If it causes cancer later... well, we've stopped using it for the last few mths... after the studies were coming out saying it could cause cancer...

I think the diet coke that Ann drinks (with aspartame) could cause cancer too, right?

Can't walking out of the house, and inhaling the next door neighbors cigarette smoke?

Sure. Limit the causes... but doesn't everyone die of something (preferably later, rather than sooner)

I think I signed an agreement that said ' I cannot sue' so thats out [img]http://uumor.pair.com/nutalle2/peanutallergy/smile.gif[/img]

So I'll stop using it... but it DID work for her. Yes, it did. It helped.

Just me.

Jason

------------------
[b]* ENRICHED * [/b]

Quote:Originally posted by jtolpin:
[b]Im tired of hearing elidel stories, which is maybe why I didnt respond to the OP.

No. Not tired of reading them. But I know the consequences of the drug... have read about it for mths now.. NOW the FDA comes out and says it...

Well... do I believe them? I don't want to think about it.

We've been using Elidel a LOT for <4> yrs now. Yes. 4.

We were in a pre-FDA approval clinical study for it.

It worked VERY well for Caitlin. VERY well.

Im not thinking about her future right now... Im MORE concerned with keeping her alive now, kwim?

If it causes cancer later... well, we've stopped using it for the last few mths... after the studies were coming out saying it could cause cancer...

I think the diet coke that Ann drinks (with aspartame) could cause cancer too, right?

Can't walking out of the house, and inhaling the next door neighbors cigarette smoke?

Sure. Limit the causes... but doesn't everyone die of something (preferably later, rather than sooner)

I think I signed an agreement that said ' I cannot sue' so thats out [img]http://uumor.pair.com/nutalle2/peanutallergy/smile.gif[/img]

So I'll stop using it... but it DID work for her. Yes, it did. It helped.

Just me.

Jason

[/b]

Wow - not sure what to say. I cringed when I read you'd used it for 4 years. But then I read more, and thought more, and like you said - we're in danger of EVERYTHING just by breathing.

Do we really want to work ourselves into a fear frenzy? We'd never leave the house. No, my original question was less about Elidel - since it is topical I figured the risks were less. But Xolair is systemic and intended to be taken for the rest of your life. THAT makes me more concerned.

Carolyn

I would question whether it causes cancer. How many people of all age groups with eczema but not using Protopic or Elidel contracted cancer in the same years mentioned in association with these drugs?? Odds probably are that these people would have gotten cancer regardless. It really bugs me when a statistic is thrown out there with no other statistics to compare it to and makes me question the validity of the statistic. As far as the monkeys go, I find testing where high, high quantities are used on animals to be of very little value when applied to people using the med appropriately. Just my opinion...

Rebekah

I guess I thought Xolair was a medication that bound itself to the allergic receptors in the body. I thought this tied up all the receptors so that other allergens did not have a place to settle in and make the body respond. I thought it was almost like having Benadryl in your body at all times. But, is it actually an immuno suppressant as people here have said?

[This message has been edited by Lisa V (edited March 14, 2005).]

From the Xolair website:

Xoliair works by "blocking IgE"

and about cancer...

"In clinical studies, cancer was seen in a small number of patients receiving Xolair as well as those receiving placebo injections
The rate was higher in patients treated with Xolair than placebo (0.5% vs 0.2%)
Several different types were seen
Please discuss this information with your doctor"

Quote:Originally posted by notnutty:
[b]From the Xolair website:

Xoliair works by "blocking IgE"

and about cancer...

"In clinical studies, cancer was seen in a small number of patients receiving Xolair as well as those receiving placebo injections
The rate was higher in patients treated with Xolair than placebo (0.5% vs 0.2%)
Several different types were seen
Please discuss this information with your doctor"[/b]

how many [i]fold[/i] increase is that?

Jason-
Good point. You put this in perspective-
Paula

We have and currently use Protopic. It's all that works for us! One thing that struck me was that there are/have been over 12 million prescriptions for the two eczema creams. There have been 25 cases of cancer.

No one wants to be one of those 25, but I think it IS important to put it into perspective.

jtolpin
your situation sounds similar to ours. my son has been using Tacrolimus/Protopic daily since he turned two in Nobember 2000 (starting wtih clinical study).
my son's ezcema was so bad when he was a baby he was miserable with red itchy sores everywhere. we started using steroid cream on him at 5 months and that's what we were using up until Tacrolimus. we hated the thought of using a steroid cream on such a young child and were so happy to find a non-steroildal cream. plus the steroid cream helped but didn't really work that well for him. the improvement from Tacrolimus came very slowly, but after a few months he looked like a different kid. when i see video or pictures of him pre-Tacrolimus I realize I have forgotten how bad he was-sores all over his hands, constantly itching. Protopic hasn't completely healed him, but it has really kept it under contol, so we are so saddended by the latest findings.
what does your allergist say about it? I'm going to try to get a hold of a few top allergists to see if they are taking their patients off this med. they way it was explained to me -and certainly seems to be for my son-is it's not something that's very helpful to use ocassionally, once a week or just for a few days or anything like that. i thought it really wouldn't work unless it was used regularly. if my son goes without it for a couple of days, he flares up again. for us i think it is every day or quitting cold turkey, but then what do we use? steroids again?
anyone else in this situation?

We are in the same situation with my son. He has had eczema since birth. When Protopic first was recommended to us, I resisted because the drug was new, but nothing else was working and several doctors recommended it (Allergist, Dermatologist). We have been using it for several years. I happened upon the FDA Alert on the FAAN website in February. I spoke to my son's pediatrician (who had not yet heard about the Protopic warning) and his Allergist who said he had, but I think he had not either because he read through what I had printed out before giving me his opinion. He was a little concerned about the report that said some tumors were found in areas treated with the medication. I decided to stop using the Protopic. We are using a steroid ointment. It doesn't work as well as Protopic, but I am just not comfortable using Protopic anymore. This time of year is a bad time for my son's eczema, so we will have to see what happens. I am a little worried about the steroid too because the doctor said to try to take breaks from the steroids if possible and he seems to need them every day. The steroid we are using is a medium strength. It is called Acclovate. We may go back to the dermatologist to see what he recommends.