Docket Management
Docket: 80N-0280 - Over-the-Counter Vaginal Contraceptive Drug Products Containing Nonoxynol 9; Required Labeling
Comment Number: EC -77

Accepted - Volume 14

Comment Record
Commentor Mrs. JoAnne Cramer Date/Time 2003-01-31 11:48:40
Organization The Orme School
Category Health Professional

Comments for FDA General
1. General Comments I am a school nurse at a 7-12 grade boarding school that accepts students from all over the U.S. and Japan, Korea, Saudi Arabia, Mexico, and South America, just to name a few. Therefore, infection control and epidemiology are of particular interest to me. Our students tend to be as promiscuous as the general population of their peers, regardless of our abstinence is best policy. Therefore, we have educated them in the use of condoms, specifically those that contain nonoxynol-9--as those are known to be much more effective in preventing pregnancy, and possibly some STD's. My concern with this new information is that students will begin using condom's without nonoxynol-9. I believe this would be more harmful in the long run. Since most condoms do not have the spermicide on the outside, which has contact with the vagina and cervix, I wonder if use of spermicidal condoms would have any effect at all on the irritation of the vaginal lining or the cervix. If the reasonable answer is no, then that should be made clear to all, so that they may continue to take advantage of the extra protection provided by spermicidal condoms without fear of HIV. I do believe that the potentially harmful effects of nonoxynol-9 and its effect on the transmission of HIV should be made public, and that the use of spermicidal LUBRICANTS definitely should be discouraged. However, it is my hope that the use of spermicidal CONDOMS will continue to be endorsed. Thank you for taking the time to consider my opinion.

EC -77