FDA proposes warning labels for products containing nonoxynol-9
BY Advocate.com Editors
January 18 2003 1:00 AM ET
The Food and Drug Administration on Thursday proposed a new label warning for over-the-counter contraceptives, including condoms, that contain the spermicide nonoxynol-9, warning that the substance does not provide protection against HIV or other sexually transmitted diseases and may actually make infection easier. The labeling change proposal is based on studies showing that nonoxynol-9 can damage the cell lining of the anus, vagina, and cervix, possibly boosting the risk of STD infection through breaks in the lining. The proposed warning label was announced in the January 16 edition of the Federal Register. FDA rules require a 90-day public comment period on the proposal.
The Gay and Lesbian Medical Association in October issued a recommendation to all sexually active gay and bisexual men to avoid using personal lubricants or condoms that contain nonoxynol-9 because of the mounting data showing that the compound facilitates HIV transmission.