The U.S. Food and Drug Administration said this week it will require manufacturers of over-the-counter vaginal contraceptive and spermicidal products to include a warning that they do not provide protection against HIV infection or other sexually transmitted diseases.
Over-the-counter spermicides include gels, foams, films, or inserts containing the chemical ingredient nonoxynol 9.
“FDA is issuing this final rule to correct misconceptions that the chemical N9 in these widely available stand-alone contraceptive products protects against sexually transmitted diseases, including HIV infection,” said Dr. Janet Woodcock, the FDA’s deputy commissioner for scientific and medical programs, in a statement. “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.”
The FDA is also requiring that the labels warn consumers that nonoxynol 9 can irritate the vagina and rectum, which may increase the risk of contracting HIV/AIDS from an infected partner.
In January 2003, the FDA proposed new warning statements and other labeling information for these products after results from a major clinical study in Africa and Thailand showed that women using a contraceptive gel product containing N9 were not protected against HIV and other STDs and were at higher risk for HIV infection than women using a placebo gel.