The Food and Drug Administration (FDA) today approved a new treatment for atopic
dermatitis (eczema) - a non-contagious skin condition that can cause redness,
itching and oozing lesions.
The drug is Protopic (tacrolimus) Ointment (0.1% and 0.03% for adults and 0.03%
for children 2 years and older). The drug is for patients with moderate to severe
eczema, for whom standard eczema therapies are deemed inadvisable because of
potential risks, or who are not adequately treated by or who are intolerant
of standard eczema therapies.
FDA based its approval on the results of three 12- week studies which indicated
that 28-37% of patients using Protopic experienced greater than or equal to
90% improvement of their skin condition, as measured by physicians, and two
one year studies that indicated that the drug is safe for intermittent long
Common side effects associated with this drug include temporary stinging or
burning sensations where the drug is applied, which may lessen if the diseased
skin heals. There was evidence from an animal study that Protopic Ointment may
accentuate the adverse effects of ultraviolet light on the skin. Therefore,
it is important that patients avoid sunlight and sun lamps, tanning beds, and
treatment with UVA or UVB light. Patients who need to be outdoors after applying
Protopic should wear loose fitting clothing that protects the treated area from
the sun. In addition, patients should ask their health care providers what other
type of protection from the sun to use.
The drug should not be used by patients who are allergic to its active ingredient,
tacrolimus, or to its inactive ingredients. Women who are breastfeeding should
also avoid using this drug. Women who are pregnant or who are planning to become
pregnant should check with their physicians before using this product.
Protopic will be marketed by Fujisawa Healthcare Inc. of Deerfield, Ill.