FDA issues warning for nonoxynol-9 products
Over-the-counter contraceptive products that contain the spermicide nonoxynol-9 (N-9) now will carry a warning label to alert consumers that such products do not protect against sexually transmitted diseases (STDs) and HIV/AIDS, following a final ruling by the Food and Drug Administration (FDA).
The move comes after the agency's January 2003 proposal to issue new warning statements and other labeling information for such products. The agency says the rule is being finalized following a public comment period and a thorough analysis of information and views from consumers, health care providers, academicians, and industry representatives.
The ruling comes as no surprise to Contraceptive Technology Update readers. Clinicians have been counseling patients on the ineffectiveness of N-9 against HIV since 2000, based on the results of microbicide research.1 This message was reinforced again in 2002, when further research indicated that N-9 failed to protect against such STDs as urogenital gonorrhea and chlamydia.2
FDA is issuing this final rule to correct misconceptions that the chemical N-9 in these widely available stand-alone contraceptive products protects against sexually transmitted diseases, including HIV infection," said Janet Woodcock, MD, FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research in an announcement on the final ruling. "Clinical research has shown that N-9 provides no protection against sexually transmitted diseases to the woman if her sexual partner is infected with an STD pathogen or HIV."
The guidance is specifically aimed at over-the-counter (OTC) stand-alone vaginal contraceptive and spermicidal products such as gels, foams, films, or inserts. The new warning information includes the following language:
- For vaginal use only.
- Not for rectal (anal) use.
- Sexually transmitted diseases (STDs) alert: This product does not protect against HIV/AIDS or other STDs and may increase the risk of getting HIV from an infected partner.
- Do not use if you or your sex partner has HIV/AIDS. If you do not know if you or your sex partner is infected, choose another form of birth control.
- When using this product you may get vaginal irritation (burning, itching, or a rash). Stop use and ask a doctor if you or your partner get burning, itching, a rash, or other irritation of the vagina or penis.
Other information in the new labeling includes:
- Studies have raised safety concerns that products containing the spermicide nonoxynol 9 can irritate the vagina and rectum. Sometimes this irritation has no symptoms. This irritation may increase the risk of getting HIV/AIDS from an infected partner.
- You can use nonoxynol 9 for birth control with or without a diaphragm or condom if you have sex with only one partner who is not infected with HIV and who has no other sexual partners or HIV risk factors.
- When used correctly every time you have sex, latex condoms greatly reduce, but do not eliminate the risk of catching or spreading HIV, the virus that causes AIDS.
- Use a latex condom without nonoxynol 9 if you or your sex partner has HIV/AIDS, multiple sex partners, or other HIV risk factors.
- Ask a health professional if you have questions about your best birth control and STD prevention methods.3
While the news on N-9 may not be new, reports about the new label warning may be of concern to couples who rely on spermicides for contraception, advises Anita Nelson, MD, professor in the Obstetrics and Gynecology Department at the University of California in Los Angeles (UCLA) and medical director of the women's health care programs at Harbor-UCLA Medical Center in Torrance. Clinicians may wish to recap the following message from Contraceptive Technology on spermicides: "Do not use spermicides to reduce risks of sexually transmitted diseases. Use male or female condoms for this purpose."4
How about condoms?
The final rule requiring warnings for all OTC vaginal contraceptives/spermicides containing N-9 applies to drug products, notes the FDA. It does not apply to condoms lubricated with N-9, which are primarily regulated as medical devices.
The agency issued draft guidance on condom labeling in 2005. Final ruling on the draft guidance has not been handed down yet.
The draft guidance calls for retail packaging of latex condoms with N-9 to include a statement indicating "that the lubricant on the condom contains N-9, which kills sperm, but that the extent of pregnancy protection contributed by the N-9 has not been measured."4 It also calls for packaging to include a statement that the N-9 in the product does not provide protection from HIV/AIDS or other sexually transmitted diseases.5
While some manufacturers have ceased manufacture of condoms of N-9, some brands continue to carry the spermicidal coating. A check of the retail web site www.condomania.com, yields eight choices: Beyond Seven, Life Styles Ultra Sensitive, Trojan Her Pleasure, Trojan Supra, Trojan Ultra Pleasure, Trojan Ultra Ribbed, Trojan Ultra Thin, and Trojan Very Sensitive.
Several organizations, including the Global Campaign for Microbicides and the San Francisco AIDS Foundation, have called for the removal of N-9 from condoms. If manufacturers will not remove N-9 from condoms, such groups are asking that the FDA require warning labels for condoms containing N-9.
- Van Damme L, Ramjee G, Alary M, et al. Effectiveness of COL-1492, a nonoxynol-9 vaginal gel, on HIV-1 transmission in female sex workers: A randomised controlled trial. Lancet 2002; 360:971-977.
- Roddy RE, Zekeng L, Ryan KA, et al. Effect of nonoxynol-9 gel on urogenital gonorrhea and chlamydial infection. JAMA 2002; 287:1,117-1,122.
- 72 Fed Reg 71,769 (Dec. 19, 2007).
- Hatcher RA, Trussell J, Stewart F, et al. Contraceptive Technology: 18th revised edition. New York City: Ardent Media; 2004.
- Food and Drug Administration. Draft Guidance for Industry and FDA Staff. Class II Special Controls Guidance Document: Labeling for Male Condoms Made of Natural Rubber Latex. Accessed at www.fda.gov.