Failure To Update

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FDA Failure to Update Nonoxynol-9 Labels to Mention Increased Risk of Contracting HIV Puts People At Risk, GAO Report Says

April 12, 2005

FDA'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.

Report Details

The new report -- which was prepared at the request of Sen. Tom Coburn (R-Okla.) -- criticizes FDA for not publicizing scientific evidence and information showing that nonoxynol-9 does not protect against HIV. "Since FDA is still in the process of completing warning label changes for N-9 vaginal contraceptive products and condoms, the public may be left in doubt about the appropriate uses of these products until FDA finalizes these warnings," the report says, adding, "Further, the public may be at risk if the products are used inappropriately." FDA said it could not comment on the GAO report or proposed label changes, the Post reports.

Coburn Comments

"The FDA is derelict," Coburn said, adding, "They've known nonoxynol-9 increases your risk of HIV, and every day they don't put that out they are harming people." He also said that FDA and CDC have an "institutional bias" toward "safe sex rather than responsible sexual activity," adding, "My definition of responsible sexual activity is monogamy with limited partners and delayed onset of sexual activity." In the past, Coburn has encouraged health agencies to "cast condoms in a dramatically different light," saying that public health officials should warn consumers about the misuse of condoms and their failure rates for preventing pregnancy and STDs, according to the Post. For example, Coburn has said that no evidence exists to show that condoms protect against certain STDs, including human papillomavirus, which causes most cases of cervical cancer (Washington Post, 4/12). NIH in 2001 released a report saying that there is insufficient evidence that male latex condoms prevent transmission of STDs other than HIV and gonorrhea (Kaiser Daily HIV/AIDS Report, 6/20/01).

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).

© Suzanne Bohan for The Oakland Tribune, ANG Newspapers

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