FDA Issues New Warnings for N9-Based Spermicides
FDA Issues New Warnings for N9-Based Spermicides

According to the FDA (The Food and Drug Administration) manufacturers of over-the-counter stand-alone vaginal contraceptive and spermicidal products containing nonoxynol 9 or N9 are now required to put a warning in the new labeling to inform consumers that use products of this type do not prevent HIV and sexually transmitted diseases (STDs).

Stand-alone spermicides containing N9 include gels, foams, films, or inserts containing N9 that are used by themselves for contraception.

According to the FDA, use of a N9 based spermicide could actually increase the risk of HIV and other STDs infection.

Nonoxynol-9 or N-9 is a non-ionic nonoxynol surfactant. In addition to its use in contraceptives as a spermicide, it is also used as an ingredient in various cleaning and cosmetic products.

The chemical was at one time widely promoted as a protection against sexually transmitted infections including HIV, according to wikipedia.com.

But actually use of nonoxynol-9 can increase the risk of HIV infection by damaging the physical barriers of the rectum or vagina, studies showed, according to wikipedia.com.   Frequent use of nonoxynol-9 is linked to higher risk of urinary tract infections (UTIs).

 “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., 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.”

FDA wants a warning put in the labeling to indicate that the chemical N9 in stand-alone vaginal contraceptives and spermicides can irritate the vagina and rectum, which may increase the risk of contracting HIV/AIDS from an infected partner.

The rule resulted from a thorough analysis of information and views from consumers, health care providers, academicians and industry, FDA said in its announcement.




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