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Medication
Topical Calcineurin Inhibitors (TCIs)
Used to treat:
Atopic dermatitis
What it does: When applied to
the skin, pimecrolimus and tacrolimus effectively reduce
inflammation along with other signs and symptoms.
How to use: The recommended
dosage for both pimecrolimus and tacrolimus is to apply a thin layer
twice a day to the affected skin as directed. Both medications are
usually prescribed for a limited time.
Neither medication should be used if a
patient has:
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A weakened immune system
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A skin infection, including chicken pox
or herpes
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Netherton’s syndrome, a rare inherited
skin condition
While using a topical calcineurin
inhibitor, the following precautions should be taken:
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Avoid sunlight and other UV exposure:
Patients should avoid exposure to sunlight, tanning beds, sun lamps,
and treatment with ultraviolet (UV) light while taking these
medications.
Sun protection is essential. Be sure to avoid the midday (between 10
a.m. and 4 p.m.) sun. Even when going outdoors for a few minutes,
follow sun-protection practices. Wear loose-fitting clothing that
protects the treated area from sunlight, apply a sunscreen with a
Sun Protection Factor (SPF) of 30 or higher to all exposed skin 20
minutes before going outdoors, use a lip protectant that has an SPF
of at least 30, and wear a wide-brimmed hat and sunglasses.
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Tell your dermatologist if you are
pregnant or breast-feeding. Women who are pregnant,
breast-feeding, or may become pregnant should discuss safety with
their dermatologist. Research shows that the oral form of tacrolimus
crosses the placenta and appears in breast milk, making it
inappropriate for use by pregnant or breast-feeding women.
In clinical trials, side effects have
been mild and temporary. Some patients using pimecrolimus experience
a mild to moderate temporary sensation of warmth or burning on the
skin when the medication is applied. Other side effects include
headache and cold-like symptoms. When applying tacrolimus, some
patients experience stinging and burning when the ointment touches
the skin.
The more severe the eczema, the more
likely the patient is to experience these side effects. The burning
sensation is usually limited to the area being treated and tends to
subside after the first week
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About the Black Box Warning
In 2006, the FDA added a black box warning to topical
pimecrolimus cream and topical tacrolimus ointment. The
warning states that use of these medications may increase the
risk of certain cancers, specifically skin cancer and
non-Hodgkin’s lymphoma.
To date, there has been no direct
link between these cancers and the topical use of these
medications. The finding is based on animal studies and a few
reports of these cancers in patients treated with a
calcineurin inhibitor. The animal studies indicate that the
risk of these cancers increases when the amount of medication
given by injection, not applied to the skin, increases.
While there have been reports of
these cancers in a few patients treated with pimecrolimus or
tacrolimus, the incidence in patients using this topical
medication does not exceed the number of cancers expected in
the population at large. Given the data, the American Academy
of Dermatology disagrees with the FDA’s addition of a black
box warning.
The Academy believes that the
data does not prove that proper topical use of pimecrolimus
and tacrolimus is dangerous,” says dermatologist Clay J.
Cockerell, M.D., 2005 president of the American Academy of
Dermatology. “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.”
Tacrolimus received FDA approval
for the treatment of moderate to severe atopic dermatitis in
December 2000. Pimecrolimus received approval in December 2001
for treating mild to moderate atopic dermatitis.
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References:
American Academy of Dermatology. “American
Academy of Dermatology Issues Statement In Response to FDA Decision
Related to Two Eczema Medications.”
American Academy of Dermatology Web site. News release issued March
10, 2005.
American Academy of Dermatology. “American
Academy of Dermatology Responds to FDA Decision on Eczema
Medications.”
American Academy of Dermatology Web site. News release issued
January 19, 2006.
Bigby, M.
“Tacrolimus and Pimecrolimus for Atopic Dermatitis: Where Do They
Fit In?” Archives of Dermatology. 2006
September;142(9):1203-1205.
All content solely
developed by the American Academy of Dermatology |
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The U.S. Food and Drug Administration (FDA) has approved
2 topical calcineurin inhibitors for the treatment of
atopic dermatitis in patients who are at least 2 years
of age:
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Pimecrolimus cream
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Tacrolimus ointment
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© American
Academy of Dermatology, 2010 All rights reserved.
