FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.
| T00-67 | Print Media: 301-827-6242 |
| December 8, 2000 | Consumer Inquiries: 888-INFO-FDA |
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 term use.
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.
Office of Public Affairs
Web page created by tg 2000-DEC-08.