FDA is requiring that the labels warn consumers 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.
In January, 2003, FDA proposed new warning statements and other labeling information for these products after results from a major clinical study in Africa and Thailand showed that women using a contraceptive gel product containing N9 were not protected against HIV and other STDs and were, in fact, at higher risk for HIV infection than women using a placebo gel
. Because these and other studies have shown that use of products containing N9 cause vaginal and rectal irritation that can heighten the chance of becoming infected with HIV from an infected partner
, FDA believes the warning will empower consumers to make better informed decisions about the use of these products, and better protect the public health.