New Warnings for OTC Vaginal Contraceptives and Spermicides

The FDA will require new warnings for OTC vaginal contraceptives and spermicides containing nonoxynol 9 (N9), including one for an increased risk of sexually transmitted diseases and HIV.

“The new warnings and labeling information will … advise consumers that the use of vaginal contraceptives and spermicides containing N9 can irritate the vagina and rectum and may increase the risk of getting the AIDS or HIV virus from an infected partner,” the agency said in a final rule published in the Dec. 19 Federal Register.

The rule applies to stand-alone vaginal contraceptives and spermicidal products. Such products include gels, foams, films or inserts containing N9.

The rule does not apply to spermicidal condoms, but labeling for contraceptives or vaginal spermicides will recommend against the use of condoms with N9 when one sexual partner has HIV, AIDS or other sexually transmitted diseases, the FDA said.

The new warnings also state that contraceptives and spermicides containing N9 may cause vaginal burning, itching or rash.

The final rule is effective June 20, 2008. It can be accessed at www.fda.gov/OHRMS/DOCKETS/98fr/80n-0280-nfr0003.pdf.