Docket Management
Docket: 80N-0280 - Over-the-Counter Vaginal Contraceptive Drug Products Containing Nonoxynol 9; Required Labeling
Comment Number: EC -140

Accepted - Volume 14

Comment Record
Commentor Ms. Amy Allina Date/Time 2003-04-16 13:44:40
Organization National Women's Health Network
Category Consumer Group

Comments for FDA General
Questions
1. General Comments I am pleased to submit these comments on behalf of the National Women's Health Network regarding the proposed new labeling warning statements for all over-the-counter vaginal contraceptive drug products containing nonoxynol-9. The National Women's Health Network is a nonprofit women's health organization that advocates for national policies that protect and promote all women's health and that provides evidence-based information to empower women to make fully informed health decisions. The Network is supported by our members and does not accept funding from pharmaceutical or medical device manufacturers. To start, the Network would like to commend FDA for this effort to provide women with accurate and reliable information, based on scientific study, about the risks associated with the use of nonoxynol-9 contraceptive products. These contraceptives, used alone as well as in conjunction with cervical barriers, provide important options to those women for whom hormonal contraception is contraindicated for health reasons as well as to those who choose to avoid methods that contain hormones for other reasons. We welcome the opportunity to give input on the information that women need regarding nonoxynol-9 contraceptive products and on the best ways to present the information so that women can understand and use it. Our comments and suggestions fall into two categories: first regarding the scope of the warnings and second regarding specific language. Scope of the warnings The majority of the studies that have found a risk associated with the use of nonoxynol-9 have examined gel products. A few have also looked at film and suppositories. The Network agrees with FDA that the warning should be included on the labels of all over-the-counter vaginal contraceptive products containing nonoxynol-9, but we ask the agency to include the fact that the information about associated risk is based on studies of gel, film and suppositories. Also, it's important for women to know that none of the studies has looked at the effects of nonoxynol-9 products when used with a diaphragm or cervical cap. This additional information might be included in a package insert rather than on the label. In addition, the Network urges FDA to require this labeling not only for vaginal contraceptive products containing nonoxynol-9 but also for condoms and lubricants which contain nonoxynol-9. Women using condoms and lubricants containing nonoxynol-9 may be exposed to a similar risk as those using vaginal contraceptives and need to receive the same warning. Although the products for which FDA is proposing this label are approved for vaginal contraceptive use, in practice they are also used rectally ? both intentionally as a lubricant and inadvertently by couples who engage in vaginal and rectal intercourse consecutively. The risks associated with rectal use of nonoxynol-9 have not been studied or documented as extensively, but they appear to be significantly greater than those associated with vaginal use. Inclusion of the statement for vaginal use only on the label is not adequate to convey this information. It is critical that FDA require a warning on the label indicating that rectal insertion of these products can increase the risk of transmitting HIV and other sexually transmitted diseases (STDs). Specific language FDA is proposing that the label instruct women who have a new sex partner, multiple sex partners or unprotected sex to ask a health care professional for recommendations regarding birth control and STD prevention methods. The Network does not believe that this is the best recommendation for women. All consumers should be warned that a study has shown that women using nonoxynol-9 products more than three times a day were at increased risk for HIV infection. They should also be informed that low frequency use of nonoxynol-9 products (one or fewer times per day) has not been shown to increase infection rates though it may cause vaginal irritation. Additionally, women who have new sex partners, multiple sex partners or unprotected sex should be specifically warned that frequent use of these products may further increase their risk of infection. The Network urges FDA to recommend that women in those groups should use condoms. We would also like to see FDA include a separate statement suggesting that women may wish to talk with a health care provider about their best birth control and STD prevention options.




EC -140