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FDA PROPOSES NEW WARNING FOR OVER-THE-COUNTER CONTRACEPTIVE DRUGS CONTAINING NONOXYNOL-9

The Food and Drug Administration (FDA) today proposed new warnings for the labels of over-the-counter vaginal contraceptive drugs that contain the spermicide nonoxynol 9. The warning would state that vaginal contraceptives containing nonoxynol 9 do not protect against infection from HIV (human immunodeficiency virus, the AIDS virus) or other sexually transmitted diseases (STDs).

The proposed label warnings would also advise consumers that the use of vaginal contraceptives containing nonoxynol 9 can increase vaginal irritation, which may actually increase the possibility of transmitting the AIDS virus and other STDs from infected partners.

FDA's proposed labeling statements are based on recent studies using nonoxynol 9, including data from a four-year World Health Organization study of 991 HIV-negative sex workers in Africa and Thailand. The study, whose final results were recently published, showed nonoxynol 9 to be ineffective in the prevention of HIV infection.

Nonoxynol 9 works as a vaginal contraceptive by damaging the cell membrane of sperm. It has been shown in laboratory studies to damage the cell walls of certain organisms that cause STDs and to be active against some STD-causing bacteria and viruses. On the basis of data that are described in the labeling proposal, FDA believes that this same membrane-damaging effect can harm the cell lining of the vagina and cervix, thereby increasing the risk of STD transmission.

FDA's proposed warning labeling for these vaginal contraceptive products containing nonoxynol 9 is being published in today's Federal Register. The agency is requesting public comment, for the next 90 days, on the proposed labeling statements and on the most effective way to present this new warning.

Interested parties may send written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.accessdata.fda.gov/scripts/oc/dockets/comments/CommentsMain.cfm?DocketNum=80N-0280&SUBMIT='CONTINUE'.

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