FDA Mandates Warning For Nonoxynol 9 OTC Contraceptive Products

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ContraceptiveProducts

FDA issueda final rule today that requires that manufacturers of over-the-counter (OTC)stand-alone vaginal contraceptive and spermicidal products containing thechemical ingredient nonoxynol 9 (N9) include a warning that the chemical N9does not provide protection against infection from HIV (the virus that causesAIDS) or other sexually transmitted diseases (STDs).

Stand-alonespermicides include gels, foams, films, or inserts containing N9 that are usedby themselves for contraception. Consumers can protect themselves from the transmissionof STDs and HIV by practicing abstinence, being in a monogamous relationshipwhere neither partner is infected, and using condoms consistently andcorrectly.

"FDA isissuing this final rule to correct misconceptions that the chemical N9 in thesewidely available stand-alone contraceptive products protects against sexuallytransmitted diseases, including HIV infection," said Janet Woodcock, M.D.,FDA's deputy commissioner for scientific and medical programs, chief medicalofficer, and acting director of the Center for Drug Evaluation and Research(CDER). "Clinical research has shown that N9 provides no protection againstsexually transmitted diseases to the woman if her sexual partner is infectedwith an STD pathogen or HIV."

Inaddition, FDA is requiring that the labels warn consumers that the chemical N9in stand-alone vaginal contraceptives and spermicides can irritate the vaginaand rectum, which may increase the risk of contracting HIV/AIDS from aninfected partner.

In January2003, FDA proposed new warning statements and other labeling information forthese products after results from a major clinical study in Africa and Thailand showedthat women using a contraceptive gel product containing N9 were not protectedagainst HIV and other STDs and were at higher risk for HIV infection than womenusing a placebo gel. Because these and other studies have shown that use ofproducts containing N9 cause vaginal and rectal irritation, which can heightenthe chance of becoming infected with HIV from an infected partner, FDA's actionis based on the need to protect the public health and empower consumers to makebetter informed decisions about the use of these products.

This ruleis being finalized following a public comment period and a thorough analysis ofinformation and views from consumers, health care providers, academicians andindustry. FDA is requiring that labeling of OTC vaginalcontraceptive/spermicidal products containing N9 bear the following warnings:

* Forvaginal use only

* Not forrectal (anal) use

* Sexuallytransmitted diseases (STDs) alert: This product does not protect againstHIV/AIDS or other STDs and may increase the risk of getting HIV from aninfected partner

* Do notuse if you or your sex partner has HIV/AIDS. If you do not know if you or yoursex partner is infected, choose another form of birth control.

* Whenusing this product you may get vaginal irritation (burning, itching, or a rash)

* Stop useand ask a doctor if you or your partner get burning, itching, a rash or otherirritation of the vagina or penis

Otherinformation in the new labeling includes:

* Studieshave raised safety concerns that products containing the spermicide nonoxynol 9can irritate the vagina and rectum. Sometimes this irritation has no symptoms.This irritation may increase the risk of getting HIV/AIDS from an infectedpartner.

* You canuse nonoxynol 9 for birth control with or without a diaphragm or condom if youhave sex with only one partner who is not infected with HIV and who has noother sexual partners or HIV risk factors

* When usedcorrectly every time you have sex, latex condoms greatly reduce, but do noteliminate the risk of catching or spreading HIV, the virus that causes AIDS.

* Use alatex condom without nonoxynol 9 if you or your sex partner has HIV/AIDS,multiple sex partners, or other HIV risk factors

* Ask ahealth professional if you have questions about your best birth control and STDprevention methods

FDA isissuing the final rule to provide a clear, consistent message that N9 is noteffective in preventing HIV transmission, and that N9 may actually facilitatetransmission of the disease for those who are at risk for HIV/AIDS. This finalrule is consistent with FDA's draft guidance for N9 use with condoms.

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