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Approval of Miconazole for Diaper Dermatitis Put on Hold by FDA Panel.

BETHESDA, MD. -- More data on the effectiveness of a topical formulation of miconazole in treating diaper dermatitis are needed before the product is approved for this indication, according to a Food and Drug Administration advisory committee.

At a meeting of the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee, the 12 panel members agreed on the need for more data on miconazole nitrate ointment. The product contains 0.25% miconazole and 15% zinc oxide in a petrolatum base, and is approved in 12 countries.

The three studies submitted to the FDA by Johnson & Johnson were cited with several limitations, including a lack of follow-up data, insignificant results in a U.S. study and a failure to address issues such as the potential for resistance.

Panel chair Dr. Lynn Drake commented at the end of the meeting that there is a great need fat such a product and urged Johnson & Johnson and other companies to pursue potential products in this area.

Dr. Drake, professor and chair of dermatology at the University of Oklahoma, Oklahoma City, characterized the panel's deliberations and votes as a "deferral" rather than a rejection of the product, noting that with a little more data, the panel could make another recommendation.

To date, no product has been approved specifically for diaper dermatitis in the United States.

All three studies enrolled infants with dermatologic signs consistent with diaper dermatitis. They were treated with vehicle or with the miconazole ointment, applied to the affected area at each diaper change and after bathing for 7 days, even if signs of diaper dermatitis were no longer visible. The studies, done in the 1980s, had been submitted to the FDA to support an unsuccessful bid for approval of miconazole as an over-the-counter treatment.

Most members of the panel wanted more information on the safety of the product when used for longer than 7 days or when used repeatedly for relapses. Most also wanted more information on the potential for antifungal resistance in infants treated with miconazole.

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Comment:Approval of Miconazole for Diaper Dermatitis Put on Hold by FDA Panel.
Publication:Family Practice News
Article Type:Brief Article
Geographic Code:1USA
Date:Aug 1, 2000
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