FDA updates Nonoxynol 9 warning

The FDA has issued a final ruling that will require manufacturers of over-the-counter stand-alone vaginal contraceptive and spermicidal products containing the chemical ingredient nonoxynol 9 (N9) include a warning that the chemical N9 does not provide protection against infection from HIV or other sexually transmitted diseases.

In addition, the 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.

The FDA has issued the final ruling to provide a clear, consistent message that N9 is not effective in preventing HIV transmission, and that N9 may actually facilitate transmission of the disease for those who are at risk for HIV/AIDS.

For more information visit www.fda.gov/OHRMS/DOCKETS/98fr/80n-0280-nfr0003.pdf.