FDA on Tuesday issued a new rule that will require vaginal contraceptives containing the spermicide nonoxynol-9 to include a warning label that the products do not prevent the spread of sexually transmitted infections, including HIV, the AP/BusinessWeek reports.
According to the rule, over-the-counter products -- including diaphragms, gels, foams and films -- will have to include the warning (AP/BusinessWeek, 12/18). The warning states that nonoxynol-9 can irritate the vagina and that products containing the spermicide may increase the risk of HIV transmission, Reuters reports. According to Reuters, FDA proposed the warning in 2003 after results from a study conducted in Africa and Thailand found women using a contraceptive gel with nonoxynol-9 were at an increased risk of HIV and other STIs.
Janet Woodcock, FDA's deputy commissioner for scientific and medical programs, said, "FDA is issuing this final rule to correct the misconceptions that the chemical N9 in these widely available stand-alone contraceptive products protects against" STIs (Reuters, 12/18). She added, "Clinical research has shown that N9 provides no protection against [STIs] to the woman if her sexual partner is infected with an [STI] pathogen or HIV." The rule will be finalized following a public comment period, as well as an analysis of information and views from health care providers, health experts and consumers (FDA release, 12/18).
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