December 19, 2007 — A new warning for nonoxynol-9 (N9) cautions consumers that the spermicide does not provide protection against infection from HIV or other sexually transmitted diseases, the US Food and Drug Administration (FDA) advised healthcare professionals yesterday. N9 gels, foams, films, and inserts are available without a prescription for contraceptive use.
"[The] FDA is issuing this final rule to correct misconceptions that the chemical N9 in these widely available stand-alone contraceptive products protects against sexually transmitted diseases [STDs], including HIV infection," says Janet Woodcock, MD, the 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 agency news release. "Clinical research has shown that N9 provides no protection against [STDs] to the woman if her sexual partner is infected with an STD pathogen or HIV."
In fact, irritation of the vagina and rectum by N9 may actually increase the risk of contracting HIV/AIDS from an infected partner, according to an alert sent from MedWatch, the FDA's safety information and adverse event reporting program. Use of N9 should be stopped if symptoms of irritation develop, such as burning, itching, or rash. However, the irritation can also be asymptomatic.
Consumers should also be warned against the use of N9 if they or their partner has HIV/AIDS or risk factors for infection such as multiple partners; in this situation, correct use of a latex condom can reduce the risk of contracting the virus. Other protective measures include abstinence and being in a monogamous relationship in which neither partner is infected.
Additional information regarding the new labeling is available at https://www.fda.gov/OHRMS/DOCKETS/98fr/80n-0280-nfr0003.pdf.
Adverse events related to use of N9 contraceptive products should be communicated to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.
Medscape Medical News © 2007 Medscape
Cite this: Yael Waknine. Nonoxynol-9 Does Not Protect Against HIV, May Increase Risk of Infection, FDA Warns - Medscape - Dec 19, 2007.