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.
Safe and Effective Eczema Medications for Young Children
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
prescribing medication, dermatologists consider several factors to
determine which medication can be safely and effectively used.
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.
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
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
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.
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.
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.
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
in patients aged two and older who are not candidates for other
therapy or who have not responded to other treatments for eczema.
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.
One Part of Effective Treatment
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
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
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,
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