"Mommy, I have the itchies!" For many families, this is a common refrain from children affected by eczema, a chronic skin condition that produces dry, itchy patches of skin on various parts of the body.

Eczema is one of the most common skin ailments around affecting some 15 million people in the United States (a whopping 20 percent of those people are children). With all of these people walking around scratching and itching, pharmaceutical companies have seized the opportunity to produce newer, innovative treatments and therapies to address the itch.

For years, conventional wisdom (and many physicians) prescribed a typical regimen of keeping the skin well moisturized, limiting bathing and using topical steroids (such as hydrocortisone) for flare-ups. Problem was, many people had trouble tolerating the steroid treatments and, at times, these treatments became ineffective.

Enter the next generation of eczema treatments: pimecrolimus (marketed as Elidel) and tacrolimus (sold as Protopic). These two topical creams were welcomed with open arms by both patients and physicians. The primarily mild side effects (sometimes a slight warming or tingling of the skin upon application) combined with exceptional reductions in symptoms, made these two creams the darlings of the eczema set.

Of course, if something seems too good to be true...

In February 2005, the U.S. Food and Drug Administration's Pediatric Advisory Committee recommended that the FDA issue a warning to healthcare providers and patients about Elidel and Protopic. This recommendation led to the FDA requiring a rare "black box warning" to be printed on all new prescriptions of either medication, as well as the distribution of a Medication Guide to patients (provided by pharmacists upon filling the prescription).

Why all of the warnings? It turns out that in a small number of animal studies (nonhuman), some findings developed showing a small risk of cancer associated with use of these medications. There have been a few human-based studies on children younger than 2 years that suggest some children who have been treated with either Elidel or Protopic might be at an increased risk for upper respiratory infections. Additionally, there have been some cases of patients developing skin cancer or lymphoma after using these medications.

The big questions, however, remain to be answered. The FDA states that human studies that either support or refute these findings could take 10 years to complete. For now, they say that these medications should be used only as second-stage treatments that is, after other treatments and therapies have failed. The FDA also states that these medications are not to be used on children younger than 2 years of age.

Truth be told, the labeling on both Elidel and Protopic has always indicated that these medications not be used on children younger than age 2; however, many, many children and infants have been prescribed the drugs (called "off-label" use) because they treat eczema and have been found to be gentler and more effective on younger patients. The FDA warning changed this practice, though some dermatologists and other physicians still believe that these creams can be used safely by children older than 2 years and adults.

The Doctors Speak Out

The stern warning about these medications came as a surprise to many patientsand to many physicians. "Initially, I was surprised by the warning," says Michael Schoenwetter, M.D., a pediatrician in Valencia, Calif., a Los Angeles suburb. "I halted my usage; however, recent data indicate no direct cause of cancer." Schoenwetter is not alone in his skepticism.

In January, the American Academy of Dermatology issued an official response to the FDA's warning: "The American Academy of Dermatology disagrees with this action taken by the FDA. We believe that the data [does] not prove that the proper topical use of pimecrolimus and tacrolimus is dangerous," said Clay J. Cockerell, M.D., president of the American Academy of Dermatology, in a statement. Cockerell continued: "Because these medications are applied to the skin, virtually none of it gets inside the body. It's not the same as taking a pill. These are valuable medications, and if used properly, they allow millions of our patients with eczema to live normal lives."

Schoenwetter says that even with the new warnings, "I have a few patients for whom these drugs are good choices." For flare-ups, Schoenwetter says he prescribes corticosteroids, and recommends maintenance with moisturizers and a decrease in the frequency of bathing to help prevent symptoms in his young patients.

To Use or Not to Use, That is the Question

So, with all of this conflicting information, many patients don't know what to do.

For many people, these second-line treatments are the only options for relief of eczema; however, many are hesitant to use them once they hear about the recent warnings. "Most patients seem unaware of the recent concerns involving Protopic and Elidel," says one pharmacist in Los Angeles who preferred not to be named. "Whether the patient asks or not, the pharmacist will go over these types of concerns with the medications. Unfortunately, it leaves most patients with more questions than answers."

Along with the new warning, the FDA has required pharmacists to distribute Medication Guides with each prescription of these medications. These guides spell out the benefits and risks of both Elidel and Protopic and reinforce their appropriate use. It seems, though, that this new onslaught of information has caused a great deal of confusionand not just for patients. "I have seen a large decline in the prescription writing for these two medications now," according to the LA pharmacist. "Patients need to remember that typically drugs used topically are on an as-needed basismeaning that when the skin is clear, the medications do not need to be used. This reduces exposure to side effects," she says.

For patients who are, indeed, confused when they arrive at the pharmacy, it's recommended that they request the printed information, review it, and then speak with their physician to discuss the risks and benefits of these medications.

Prevent Flare-Ups

Of course, the best treatment for eczema is preventing flare-ups in the first place. For some people, that may require identifying allergens that trigger the response. For others, it may consist of being very serious about keeping the skin well hydrated. For little ones, limiting fragrance and other irritants can help reduce episodes. Some parents swear by the Vanicream line. Others like Free & Clear or California Baby. Check with your dermatologist or pediatrician for recommendations.

When the rash flares despite your best efforts, mild topical cortisone treatments aimed at also helping the healing process are excellent options. DERMAdoctor Handy Manum Medicated Skin Repair Serum with 1% Hydrocortisone or Cortaid Maximum Strength Cream can be applied twice a day during flare-ups to help keep your child comfortable and help promote healing.

Oral antihistamines are also important. If your dermatologist or pediatrician has not made a recommendation, consider trying Children's ZYRTEC Allergy Liquid Grape Flavor. The wonderful thing about any syrup formulation that has potential problems causing sleepiness is being able to give a bit less to help reduce drowsiness without losing the benefits.

Above all, remember to apply moisturizers while the skin is still damp to increase the amount absorbed by the skin.

Even with all of the confusion, all of the experts agree on one thing: Always consult your physician and be sure to use only medications that have been prescribed for youand always follow the precise instructions.

Robin Heinz Bratslavsky
DERMAdoctor Staff Writer

(Any topic discussed in this article is not intended as medical advice. If you have a medical concern, please check with your doctor.)

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