The American Academy of Dermatology (Academy) opposes the “black box” warning that the Federal Drug Administration (FDA) will require on two medications, pimecrolimus and tacrolimus, which are used to treat atopic dermatitis.

In a statement issued March 10, 2005, the Academy’s president, dermatologist Clay J. Cockerell, M.D., said, “The American Academy of Dermatology is disappointed that the FDA has taken this action, despite the fact that there is no data that proves proper topical use of pimecrolimus and tacrolimus is dangerous in people.” Dr. Cockerell added, “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.”

For the Academy’s complete statement, visit American Academy of Dermatology Issues Statement in Response to FDA Decision Related to Two Eczema Medications.

EczemaNet Article
Safe and Effective Eczema Medications for Young Children

Parents often voice concern that their child is too young for the medications used to treat eczema, especially when the child is an infant. The fact is that some medications can be used to safely and effectively treat eczema in children of all ages.

The key to safe and effective use of medication lies in knowledge and training. Board-certified dermatologists and pediatric dermatologists have the experience and medical training necessary to safely prescribe these medications. Dermatologists know how to effectively monitor patients and incorporate creative treatment strategies to minimize side effects.

When prescribing medication, dermatologists consider several factors to determine which medication can be safely and effectively used. Factors include:

  • Patient’s age

  • Location and condition of skin to be treated

  • Severity of the symptoms

  • Previous treatment history

The amount of skin affected and where on the body the affected skin lies play a major role in determining what medications may be safely prescribed. More than 50 years of medical literature indicates that some side effects directly correlate to where and how the medication is applied. For example, some medications must be used with care around the eyes and areas that are bandaged or diapered.

Medications that dermatologists use to safely and effectively treat eczema in infants and young children include antibiotics, antihistamines and corticosteroids. In clinical trials, two steroid-free topical medications, pimecrolimus and tacrolimus, also are proving safe and effective for children less than two years of age who suffer from the most common type of eczema, atopic dermatitis.

Antibiotics, Antihistamines and Corticosteroids
Dermatologists routinely prescribe these medications to treat children with eczema. Certain antibiotics can be safety used, even in children under six months. Dermatologists know which antibiotics to prescribe and how the medications should be used. It is important to use these medications exactly as prescribed to maximize safety and effectiveness.

Studies confirm that antihistamines are safe and not associated with significant adverse side effects, even in young patients when taken as prescribed. However, taking a higher-than-prescribed dose can be dangerous, especially for young children.

Topical corticosteroids, the mainstay for treating eczema, are used to diminish the inflammatory response. These medications have been used since 1951 to treat a wide variety of skin conditions. To minimize the potential for side effects, dermatologists carefully monitor patients using corticosteroids for any period of time.

Parents should know that dermatologists strive to use the mildest forms of medication possible in order to minimize potential side effects. However, a higher-potency medication may be prescribed for a short period to address an acute situation. Once the condition subsides, a milder medication is prescribed to replace the stronger one.

Pimecrolimus and Tacrolimus
Pimecrolimus and tacrolimus belong to a class of drugs called calcineurin inhibitors. Blocking calcineurin prevents the release of chemicals in the immune system that cause the inflammation, redness and itching. The U.S. Food and Drug Administration (FDA) approved these two steroid-free medications for the treatment of atopic dermatitis in patients aged two and older who are not candidates for other therapy or who have not responded to other treatments for eczema.

Data from clinical trials suggests that these medications may safely treat atopic dermatitis in children younger than two years of age. In a recent study, tacrolimus was applied to 12 patients under two years of age. Dermatologists found that the symptoms improved and patients did not experience significant side effects. In another study, pimecrolimus, which is considered milder, was used to treat 186 infants younger than two who had mild to moderate atopic dermatitis. Fifty-five percent of the infants cleared or nearly cleared after six weeks of treatment. Another study, which was conducted in Germany, used pimecrolimus to treat 196 infants aged two to 23 months. Reported findings indicate that pimecrolimus was effective and appeared safe. This early data suggests that both medications may be safe for children younger than two years of age and that both medications can be used on large areas of the body.

Medication Only One Part of Effective Treatment
Parents should keep in mind that while medication can safely and effectively treat eczema, it is only one part of an effective eczema treatment plan—regardless of a patient’s age. Medication may not be fully effective without making lifestyle modifications.

When a young child has eczema, responsibility for making lifestyle modifications becomes the responsibility of parents or caregivers. This can be a challenge. The child’s skin should be moisturized frequently throughout the day to relieve the dry, itchy feeling. Moisturizing is especially important after a bath when moisturizer should be applied while the skin is still damp to lock in the much-needed moisture. Additionally, the child’s fingernails should be kept short, and adults must distract the child with plenty of activities to suppress the urge to scratch. Techniques that can help ease the itch include, dressing the child in loose-fitting cotton clothes and ensuring that the child does not become overheated or emotionally stressed.

It also is important that parents and caregivers consider the triggers that may cause a child’s skin to flare. Some clothing and certain soaps, for instance, may cause itching or flares. Each child is unique and what causes one child’s eczema to flare may not trigger a flare-up in another child. A bit of detective work is required to uncover the culprits. Keeping a trigger journal can help isolate and identify the triggers.

Making lifestyle modifications plays an important role in keeping eczema under control. However, once skin inflammation occurs, medication often becomes necessary to manage the condition. When medication is prescribed by a board-certified dermatologist and used as directed, it can safely and effectively help relieve the symptoms.

Boschert, S. “Early Data Suggest Calcineurin Inhibitors are Safe for Infants.” Skin and Allergy News, February 2004, p. 28

Kirn, T. “Topical Pimecrolimus Controls Eczema in Infants” Skin and Allergy News, November 2003,
p. 27.

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