FDA Approves Tacrolimus for the Treatment of Eczema

FDA Approves Tacrolimus for the Treatment of Eczema – Protopic

Monica Preboth

The U.S. Food and Drug Administration (FDA) has approved a new treatment for eczema. Tacrolimus (Protopic) is available in 0.1 and 0.03 percent ointment for adults and 0.03 percent ointment for children two years and older.

Tacrolimus ointment is intended for patients with moderate to severe eczema, for whom standard treatments are inadvisable because of potential risks, or who are not adequately treated by or are intolerant of standard eczema therapies. In clinical trials, 28 to 37 percent of patients using tacrolimus had at least 90 percent improvement of their skin condition as measured by physicians. The trials also found that tacrolimus is safe for intermittent long-term use.

Side effects commonly associated with tacrolimus include temporary stinging or burning sensations where the ointment is applied, although this may lessen if the diseased skin heals. The adverse effects of ultraviolet light on the skin may be intensified. Therefore, patients should avoid exposure to sunlight and sunlamps, tanning beds and treatment with UVA or UVB light. Patients treated with tacrolimus ointment who need to be outdoors should wear loose fitting clothing to shield treated skin from the sun.

Patients who are allergic to tacrolimus or its inactive ingredients should not use this drug. Tacrolimus should not be used in breast-feeding women, and women who are planning to become pregnant should discuss use of this drug with their physician.

For more information on tacrolimus ointment, contact the FDA at 888-INFO-FDA (888-463-6332).

COPYRIGHT 2001 American Academy of Family Physicians

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