Docket Management
Docket: 80N-0280 - Over-the-Counter Vaginal Contraceptive Drug Products Containing Nonoxynol 9; Required Labeling
Comment Number: EC -30

Accepted - Volume 14

Comment Record
Commentor Dr. Roe Gallo Date/Time 2003-01-26 16:17:12
Organization IASHS
Category Health Professional

Comments for FDA General
Questions
1. General Comments N-9 has been successfully tested and used for over 20 years. It would not be wise to base this warning on the study done on the African sex workers because this study was not representative of how N-9 is actually being used. By the end of the study the infection rate was 50% higher in the N-9 group than the placebo group. (NIAID, 2000) WHY? The women who used nonoxynol-9 had a high incidence of vaginal lesions. Studies have consistently shown that liaisons are a breading area for infection. (CDC, 2000). Using a high percentage gel of nonoxynol-9 on the delicate mucosa of the vagina, without a substantial buffering agent, can be compared to douching with TIDE! This form of irritation kills vaginal-wall cells, causing ulceration and thus giving the virus an entry-point. On top of that you add the factor of multiple intercourse and douching between clients because of the nature of their trade, and you can logically see how the study failed to give anything but poor results.




EC -30