FDA Notifications: New labeling for N-9 products?
Based on the results of several clinical trials, the Food and Drug Administration (FDA) has proposed new labeling for over-the-counter vaginal contraceptive drug products that contain nonoxynol 9 (N-9). The warning statements will tell consumers that vaginal contraceptives containing N-9 do not protect against HIV or other sexually transmitted diseases. The trials showed that frequent use of N-9 products raise the risk of infection through increased vaginal irritation. The FDA will seek public input on the proposed statement as part of its ongoing review of over-the-counter drug products.