FDA Says Spermicidal Contraceptives with Nonoxynol 9 Won't Stop HIV, Can Make Infection More LikelyDec 19, 2007 | Parker Waichman LLP
Some contraceptives will soon bear a warning that they do not protect users from HIV, the virus that causes AIDS, and other sexually transmitted diseases (STDs). Spermicidal gels, foams, creams and films used by many women to protect against unwanted pregnancies contain a chemical call nonoxynol 9, which has been known to kill the viruses that cause AIDS and other STDs in test tubes. However, research has proven that the microbial effects of nonoxynol 9 are nonexistent during actual use, and in fact, side effects of these drugs could actually make it more likely that STDs will be transmitted between partners.
Yesterday, the Food & Drug Administration (FDA) mandated that all over-the-counter stand-alone spermicidal gels, creams, foams and films that contain nonoxynol 9 include a warning that the contraceptives offer no protection from sexually transmitted diseases, and could actually increase the chances of infection. In a statement announcing the new nonoxynol 9 warning, the FDA said the warning was necessary to “correct misconceptions that the chemical nonoxynol 9 in these widely available stand-alone contraceptive products protects against sexually transmitted diseases, including HIV infection.” According to the FDA, consumers can only protect themselves from the transmission of STDs and HIV by practicing abstinence, being in a monogamous relationship where neither partner is infected, and using condoms consistently and correctly.
The FDA had actually proposed the nonoxynol 9 warning in 2003, after results from a major clinical study in Africa and Thailand showed that women using a contraceptive gel product containing nonoxynol 9 were not protected against HIV and other STDs. That same study also found that the women using the contraceptive gels were at a somewhat higher risk of contracting STDs. It was surmised that contraceptives containing nonoxynol 9 dry out and irritate the vaginal walls. This scenario would make it far easier for viruses and other microbes to infect the user. The FDA said the new nonoxynol 9 rule was being finalized following a public comment period and a thorough analysis of information and views from consumers, health care providers, academicians and industry.
In addition to the HIV/STD notice, nonoxynol 9 products will now bear warnings stating that they are intended for vaginal use only, and should not be used rectally. The label also cautions that the products should not be used if the user or their partner has HIV/AIDS, and it recommends that another form of birth control be used if the partner’s HIV status is unknown. Finally, the label states that nonoxynol 9 can cause vaginal irritation, including burning, itching, or a rash, and advises consumers to stop using a product if they or their partner experience burning, itching, a rash or other irritation of the vagina or penis.