Policy & Politics
FDA Failure to Update Nonoxynol-9 Labels to Mention Increased Risk of Contracting HIV Puts People At Risk, GAO Report Says
April 12, 2005
's failure to update the labels of products containing the spermicide nonoxynol-9 to warn of the increased risk of contracting HIV among women who use the products puts consumers at risk, according to a Government Accountability Office report scheduled to be released on Tuesday, the Washington Post reports (Connolly, Washington Post, 4/12). Nonoxynol-9 works as a vaginal contraceptive by damaging the cell membranes of sperm, and some laboratory evidence has shown that the spermicide damages the cell walls of some organisms that cause sexually transmitted diseases and is active against some bacteria and viruses. However, according to data presented in January 2003, nonoxynol-9's membrane-damaging effect also can harm the cell lining of the vagina and cervix, possibly increasing the risk of contracting sexually transmitted diseases, including HIV, among women who use it (Kaiser Daily HIV/AIDS Report, 3/24/04). Although the U.S. surgeon general, FDA, CDC and NIH in 1988 said that condoms with nonoxynol-9 might provide additional protection against HIV, CDC in 2000 revised its guidelines and warned that the spermicide "may actually increase the risk of contracting HIV when used frequently." FDA in 2003 concluded that nonoxynol-9 might increase a person's risk of contracting HIV, but so far the agency has not issued new consumer warning labels, according to the Post.
Some Companies No Longer Use N-9
The World Health Organization and UNAIDS also have raised concerns about the use of nonoxynol-9 in condoms. As a result, several companies -- including SSL International, the maker of Durex condoms; Johnson & Johnson, which makes K-Y brand personal lubricant; and Mayer Labs, which makes the Kimono brand of condom -- have stopped manufacturing condoms with nonoxynol-9 (Kaiser Daily HIV/AIDS Report, 1/21/04).
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This article was provided by Henry J. Kaiser Family Foundation. It is a part of the publication Kaiser Daily HIV/AIDS Report. Visit the Kaiser Family Foundation's website to find out more about their activities, publications and services.