FDA calls alert: nonoxynol-based contraceptives do not protect from AIDS

(by Margarita Snegireva) U.S. officials required that some producers of contraceptive gels, foams, films and inserts should carry a warning on their label that they do not protect against such diseases as AIDS.

Photo: FDA calls alert: nonoxynol-based contraceptives do not protect from AIDS

The U.S. Food and Drug Administration will require the warning on over-the-counter products containing nonoxynol 9, used in many stand-alone spermicides.

"FDA is issuing this final rule to correct the misconceptions that the chemical N9 in these widely available stand-alone contraceptive products protects against sexually transmitted diseases," Janet Woodcock, FDA's deputy commissioner for scientific and medical programs, said in a statement.

Nonoxynol-9's ability to kill microbes in vitro was initially taken as evidence that it might be effective at preventing STI transmission. However, more recent findings indicate that it may actually increase a person's risk of contracting STIs, especially if used frequently. This is because the chemical causes tiny abrasions inside the sensitive vaginal and anal walls. These abrasions may make transmission more likely especially if condoms are not used.

From 1996 to 2000, a UN-sponsored study carried out in several locations in Africa followed nearly 1000 sex workers who used nonoxynol-9 gels or a placebo. The HIV infection rate among those using nonoxynol-9 was about 50% higher than those who used the placebo; those using nonoxynol-9 also had a higher incidence of vaginal lesions, which may have contributed to this increased risk. Regular use of nonoxynol-9 likely increases the risk of infection with sexually transmitted human papillomaviruses (HPVs) that can cause cervical cancer. While these results may not be directly applicable to lower-frequency use, these findings combined with lack of any demonstrated HIV-prevention benefit from nonoxynol-9 use have led most major health agencies to recommend that it no longer be used by women at high risk of HIV infection. The WHO further notes that "Nonoxynol-9 offers no protection against sexually transmitted infections such as gonorrhoea, chlamydia ."

Nonoxynol-9 based products (including condoms containing the spermicide) should not be used for prevention of HIV or STDs or for contraception between non-monogamous partners because of the increased risk of infection by HIV or sexually transmitted infections. However, non-spermicide condoms are available and are still highly successful at preventing both pregnancy and STD transmission.

Frequent use of nonoxynol-9 is linked to higher risk of urinary tract infections(UTIs).