Elidel and Protopic cancer risk

[Acura NsX Pilot]

I have been afflicted with Eczema all my life and it is not fun. There is no cure for it and only treatments which do very little IMO to help. Any who this was recently published and just wanted to bring it to the attention of anyone using one of these cremes.






Eczema Treatments Get New Cancer Warning

Elidel and Protopic to Carry the FDA's Strongest 'Black Box' Warning

By Jennifer Warner
WebMD Medical News Reviewed By Michael Smith, MD
on Thursday, March 10, 2005

The FDA is warning doctors to prescribe two popular eczema treatmentseczema treatments with caution after concerns over a possible cancer risk associated with their use.

The two creams, Elidel and Protopic, will also soon carry the FDA's strongest "black box" warning on their packaging to alert doctors and patients to these potential risks. The warning advises doctors to prescribe short-term use of Elidel and Protopic only after other available eczema treatments have failed in adults and children over the age of 2.

At a meeting last month, the FDA's Pediatric Advisory Committee reviewed research in animals that linked Elidel and Protopic to an increased risklinked Elidel and Protopic to an increased risk of skin cancer and non-Hodgkin's lymphoma. In those studies, the risk of cancer increased as the dose of the drugs increased.

Research presented at the meeting also linked Elidel and Protopic to about 25 cases of cancer in adults and children who used the drugs.

The FDA has also received reports of serious adverse events in children under the age of 2 who were prescribed the drugs, although they have not been approved for use in children in this age group.

Elidel was approved in 2001 and Protopic in 2000 to treat adult eczema,eczema, which is an inflammatory condition of the skin affecting about 15 million Americans, 20% of whom are children. The condition causes dry, red, itchy skin that can blister or develop scaly patches.

Since their approval, the FDA estimates that more than 12 million prescriptions have been written for Elidel and Protopic. Both drugs are applied to the skin to control eczema by suppressing the immune system and are viewed as an alternative to the steroid-based drugs cuwrrently used to treat eczema.

Research to Examine Cancer-Eczema Link Underway

The FDA says manufacturers of Elidel and Protopic have agreed to conduct research to determine whether there is an actual risk of cancer in humans, and, if so, its extent.

The FDA's warning advises doctors to weigh the risks and benefits of these drugs in adults and children and to consider the following:

Elidel and Protopic are approved for short-term and intermittent eczema treatment in people who have not responded to or are intolerant of other eczema treatments.
Elidel and Protopic are not approved for use in children younger than 2 years old. The long-term effect of Elidel and Protopic on the developing immune system in infants and children is not known. In clinical trials, infants and children younger than 2 years of age treated with Elidel had a higher rate of upper respiratory infections than those treated with a placebo cream.
Elidel and Protopic should be used only for short periods of time, not continuously. The long-term safety of these products is unknown.
Children and adults with a weakened immune system should not use Elidel or Protopic.
Use the minimum amount of Elidel and Protopic needed to control the patient's symptoms. The animal data show that the risk of cancer increases with increased exposure to Elidel or Protopic.

--------------------------------------------------------------------------------

SOURCES: News release, FDA. WebMD Medical News, "Cancer Warning Suggested for Eczema Creams.""Cancer Warning Suggested for Eczema Creams."

 

[Juice]

Yeah, it sucks. What the public fails to understand about drug manufacturing is that ALL drugs created have the potential for serious side effects. Whenever a drug is found to have these dramatic possible effects, the consumer finds the manufacturer at fault and starts the cross a'burnin. Truth is, it is the patient who creates the need for the drug. The manufacturer can only cheat the human body so much before something gives and the drug's short comings are realized.

I have a dear friend with eczema who uses Protopic. I feel tied because I want the best for him, but how do you give a friend a drug that you know could have serious long term life ending side effects? It is always up to the patient as to how much risk they are willing to take in order to treat a condition.

 

[DocL]

My dermatologist prescribed Elidel for me last year and I only used it for one week. I've never before had such a reaction from a topical cream. The areas where I applied it started to have a severe burning sensation, and I also started to develop a slight fever. I looked it up in my PDR and decided that there were too many possible side effects that I personally was too concerned about. I decided to stick to an OTC 1% Hydrocortisone cream.

 

[jalnjr]

i got the same crap for my spots... i never thought "sticker shock"
would be a side effect

good ol' hydrocortisone, betameth for toughies [use minimally]...

ketoconazole2% cream too, since most dermal lesions [bacterial &/or immuno]
have mixed flora... btw cures dandruff[ nizoral shampoo ], but i digress.

 

[Wheelman]

Elidel and Protopic are not approved for use in children younger than 2 years old

Thank you so much for posting this. My son's Pediatrician prescribed him some Protopic for my 7 month old son. I took the Protopic and threw it away!

I am glad this forum talks about every subject matter in life and not just our cars.

Acura_NsX_Pilot, I owe you a beer..:smile:

 

[710]

Drugs: Watch out for the quantity used too. My father’s doctor prescribed him some medicine, not eczema, for his eyes and dizziness.
My father gradually reduced the dosage until it didn’t work anymore. He got down to 1/3 the dosage!
Holy smoke.

 

[SCS2k]

Before everyone starts to throw out all of their prescription medications, make sure you put this into perspective. The risk of cancer mentioned is quite small and these medications provide significant relief to millions of people. I'm not in any way promoting these drugs but lets not all go off of the deep end.

 

[steveny]

I have used both creams in the past. Total use is 6 months to a year. I read this article the other day on Yahoo and have to say I am pretty worried about it for sure.
The article did not say if this is a long term side effect or something that happens short term. Seems like the article says 12 million prescription written and around 20 people ill effected although Yahoo reported 76.
Any doctors on here care to share their opinion?

 

[Acura NsX Pilot]

I have used both creams in the past. Total use is 6 months to a year. I read this article the other day on Yahoo and have to say I am pretty worried about it for sure.
The article did not say if this is a long term side effect or something that happens short term. Seems like the article says 12 million prescription written and around 20 people ill effected although Yahoo reported 76.
Any doctors on here care to share their opinion?

I asked my dermotologist about it and he said that you would have to take it in a strong dose for a prolonged period of time for there to be any danger. He also mentioned that the chimpanzees that got the lymphoma were on the new oral version they were testing and also in concentrated doses.

 

[steveny]

I asked my dermotologist about it and he said that you would have to take it in a strong dose for a prolonged period of time for there to be any danger. He also mentioned that the chimpanzees that got the lymphoma were on the new oral version they were testing and also in concentrated doses.

That eases my mind a little bit. On the other hand lymphoma killed my uncle at my age. :frown:

 

[nchopp]

My mom's a Pharmacist, so I've been hearing first-hand information regarding drugs, pharmaceutical companies, and the like for a LONG time. It's really refreshing to see an article like this minus all the usual bashing on the pharmaceutical companies. People never stop to think about the BILLIONS of dollars these companies spend on drugs that never even end up making it to FDA testing - much less the ones that make it to FDA and DON'T get approved. Sure, there are greedy people in the industry - but there are also those that are just trying to further the cause of medicine - to reduce suffering.

 

[docmental]

This thread is way too painful for me, sounds like work....I'm going home.

 

[SCS2k]

Any doctors on here care to share their opinion?

I already did.

 

[pelletz]

I am a physician assistant in dermatology and have heard about these above mentioned reports. The risk of lymphoma with topical use of elidel or protopic would be extremely rare. I believe the reports came about from the oral admistrations of such drugs at higher dosages. If you are using it to treat your eczema i do not feel there is need for alarm. In my experience, these two medications work very poorly and are very expensive, thus i never use for my patients. A mid to high potency steriod used 3 to 4 times a day will clear the eczema usually in about a week. Then to reduce flares, it is important to use gentle soaps (i.e. dove, cetaphil, aveeno) and moisturize within 5 minutes of bathing. Occassionally, eczema can become secondarily infected and the use of antibiotics is also needed. A daily antihistamine (claritin, clarinex, zyrtec) can also be of benefit. Some children outgrow their eczema (atopic dermatitis), while others deal with it all their lives.

My feeling is that one should look at the big picture when deciding upon treatment or drug for a medical condition. For example, suffer daily from an affliction vs. treat that condition for improved quality of life and accept the potential risks. All doctors, NP's, or PA's can do is give you the best information to make a well informed decision.

 

[pelletz]

I did some research and have some data if interested. Out of the 1.7 million people using protopic 22 lymphomas were recorded. Of the 22 lymphomas, 7 of these were cutaneous t-cell lymphomas, which can look like eczema for years before it becomes apparent that it is not really eczema, but a lymphoma to start with, thus protopic did not cause these 7.

Just being apart of the general population, you have a risk of developing lymphoma without using anything. There is an increased risk with the oral forms of the drugs, but the topical use doesn't put you at any real risk. The sun that you get everyday, is WAY more carcinogenic then protopic. Skin cancer is responsible for more cancers, then ALL other cancers combined. Let's all put things into perspective.

 

[steveny]

Thank you for posting this info.