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Executive Summary

OTC VAGINAL CANDIDIASIS LABELING TO INCLUDE HIV WARNING advising patients who experience frequently recurring or recalcitrant vaginal yeast infections that they may be infected with HIV. FDA approved labeling changes for the currently-marketed OTC yeast infection products in early October. Ortho's Monistat 7 (miconazole) cream and suppositories will include the warning in the next set of labels produced for the product, the company said. Other marketed OTC vaginal candidiasis treatments are Schering-Plough's Gyne-Lotrimin and FemCare (clotrimazole 1% cream and vaginal tablets) and Miles' Mycelex-7 (also clotrimazole). The labeling change includes a "bullet" under the "warnings" section that states: "If you may have been exposed to the human immunodeficiency virus...and are now having recurrent vaginal yeast infections, especially infections that don't clear up easily with proper treatment, see your doctor promptly to determine the cause of your symptoms and to receive proper treatment." A warning to be added to the back panel of packaging would state: "If your symptoms return within two months or if you have infections that do not clear up easily with proper treatment, consult your doctor. You could be pregnant or there could be a serious underlying medical cause for your infections, including diabetes or a damaged immune system (including damage from infections with HIV -- the virus that causes AIDS)." Similar statements would be added to the educational brochure provided with the product. Current labeling for OTC yeast infection treatments contains a statement that if there is no improvement or the infection worsens within three days or if complete relief is not felt within seven days, or if the symptoms recur within two months, "you may have something other than a yeast infection." FDA had planned to bring the labeling issue before its Anti- infective Drugs Advisory Committee at its Oct. 26-27 meeting but said the issue was removed from the agenda because the manufacturers of the OTC yeast infection treatments agreed to the labeling change. The firms initially had opposed the warning on the grounds that it would potentially frighten many patients unnecessarily because a very small portion of the patients with recurring or recalcitrant infections would be HIV-positive.

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