January 17, 2002
FDA PROPOSES NEW WARNING FOR
OVER-THE-COUNTER CONTRACEPTIVE DRUGS CONTAINING NONOXYNOL-9
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
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
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'.