FDA requiring new warning on N9 contraceptives
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On December 18, 2007, the United States Food and Drug Administration (FDA) announced that manufacturers of contraceptives containing nonoxynol 9 (N9) must state on product packaging that the products do not protect against sexually transmitted diseases (STDs).
?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 Janet Woodcock, M.D., the FDA?s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research (CDER).
?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.?
According to clinical studies reviewed by the FDA, N9 may cause irritation that actually increases the chance of contracting HIV from an infected partner. As such, the FDA recommends that those who suspect they or a partner may have HIV should not use N9 as a contraceptive.
Source: U.S. Food and Drug Administration, ?FDA Mandates New Warning for Nonoxynol 9 OTC Contraceptive Products,? December 18, 2007.








