Food and Drug Administration, U.S. Department of Health and Human Services - November 16, 1992
Monica Revelle - (301) 443-4177

HHS Assistant Secretary for Health James Mason, M.D., who heads the Public Health Service, said most of the 13 million cases of vaginal candidiasis that occur annually do not have HIV as an underlying cause. "Pregnancy, diabetes, contraceptive pills and antibiotics are commonly linked to these fungal infections," he said.

"But any woman at risk for AIDS," Dr. Mason continued, "should be aware of the possibility that recurrent or stubborn cases of vaginal candidiasis sometimes may be an early sign of infection with the human immunodeficiency virus, HIV, that causes AIDS -- and should check with a doctor. That is the purpose of this statement -- and of new labeling for nonprescription drugs for vaginal candidiasis."

According to recent studies, recurrent or stubborn cases of vaginal candidiasis are the most frequent initial clinical manifestation of HIV infection in women. One study showed that of women diagnosed with HIV- caused immunosuppression, 38 percent suffered recurring or persistent cases of vaginal candidiasis as their first symptom.

"Having this information in hand," said Food and Drugs Commissioner David A. Kessler, M.D., "the agency has requested that manufacturers of nonprescription drugs for vaginal candidiasis include a new label warning that women who may have been exposed to HIV infection and who experience recurrent or persistent cases of vaginal yeast infections seek professional medical attention promptly."

Miconozole nitrate, marketed under the name brand Monistat-7, and clotrimazole, marketed as Gyne-Lotrimin, Mycelex-7 and FemCare, are sold without prescription for treatment of vaginal candidiasis in patients who have had a previous episode of vaginal candidiasis diagnosed by a physician. The labeling of these products already states that recurrent infections may result from hormonal changes or use of oral contraceptives or antibiotics.

The additional warning will state: "In women with frequently recurrent vaginal yeast infections, especially infections that don't clear up easily with proper treatment, the vaginal yeast infections may also be the result of serious medical conditions, including infection with HIV, that can damage the body's normal defenses against infection."

"Women should be made aware through all available sources that if they are experiencing recurrent vaginal yeast infections within a two-month period or if their infections don't clear up with proper medical treatment, they should see their doctor for professional diagnosis and treatment," Dr. Kessler said. "In view of the growing epidemic of AIDS among women, it is important that they be alert to possible early HIV infection."

Women who need further information on risk factors for HIV infection or testing for HIV infection should contact their physician or the Centers for Disease Control and Prevention National AIDS Hotline at 1-800-342-AIDS. Separate CDC hotline numbers are also available for Spanish speaking persons (1-800-344-7432) and for the hearing impaired, (TDD 1-800-243-7889).

FDA and and CDC are agencies of the Public Health Service within HHS.
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SOURCE: Food and Drug Administration (FDA).

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