Dec. 18, 2007 -- The FDA today ordered a new warning for the spermicide nonoxynol-9 in over-the-counter gels, foams, films, or inserts.
Those products' labels must now include these warnings:
- Nonoxynol-9 doesn't protect against HIV or other sexually transmitted diseases (STDs)
- Nonoxynol-9 may irritate the vagina and rectum, which may increase the risk of contracting HIV/AIDS from an infected partner.
The FDA made the rule to "correct misconceptions that the chemical N9 in these widely available stand-alone contraceptive products protects against sexually transmitted diseases, including HIV infection," Janet Woodcock, MD, says in a news release.
"Clinical research has shown that N9 provides no protection against sexually transmitted diseases to the woman if her sexual partner is infected with an STD pathogen or HIV," says Woodcock, who is the FDA's deputy commissioner for scientific and medical program, chief medical officer, and acting director for the FDA's Center for Drug Evaluation and Research.
The FDA first proposed new warnings for nonoxynol-9 nearly five years ago, after a study from Africa and Thailand showed that women using a contraceptive gel product containing N9 weren't protected against HIV and other STDs and were more likely to develop HIV infection than women using a placebo gel.