FDA orders lubes, condoms with N-9 to carry warnings

Posted on 27 Dec 2007 at 7:44pm
By Bob Roehr Contributing Writer

Spermacide once thought to help prevent transmission of HIV may actually promote transmission of AIDS, other STDs



Volunteer workers dress up as condoms as part of an AIDS awareness event earlier this year in Korea. The FDA has issued an ruling saying condoms containing N-9 in the U.S. must contain a warning of possible health risks.

The US Food and Drug Administration has added a warning label to sexual lubricants and contraceptive products containing the spermicide nonoxynol 9 (N-9) that it may increase the risk of acquiring HIV and other sexually transmitted diseases.

The final ruling on the warning was issued on Dec. 18.

N-9 is a spermicide that is used to protect against contraception.

It has been used in a variety of sexual lubricants and also applied to products like condoms and diaphragms.

The original hope was that it might protect against HIV as well.

But in 2000, the first research showed that N-9 was highly toxic when used in the rectum. It causes shedding of whole sheets of epithelium, the single layer of cells in the rectum and lower intestine that provide the first line of barrier defense against infections in those tissues.

Subsequent research established that moderate vaginal use of products containing N-9 can irritate that tissue and lead to increased rates of HIV infection.

The FDA first issued a warning about use of N-9 in 2003. Members of the gay community and experts in sexually transmitted diseases began a campaign to educate persons to the risks of products containing N-9 and to urge companies to drop the spermicide from lubes.

Most eventually agreed to do so, though some required more persuasion than others.

“FDA is issuing this final rule to correct misconceptions that the chemical N-9 in these widely available stand-alone contraceptive products protects against sexually transmitted diseases, including HIV infection,” said Janet Woodcock, FDA’s chief medical officer.

Products containing N-9 must now carry a warning that they are for vaginal use only; not for rectal use; not for use if either partner has HIV; and that use may increase the risk of transmission of STDs.

Walt Senterfitt, chairman of the board of the national HIV prevention advocacy group CHAMP, said, “The data providing the basis for this announcement have been around for years and it is outrageous that it has taken this long for the FDA to act.”

“This underscores once again the urgent need for better and more HIV prevention tools, and for freeing the tried-and-true ones from bans and hobbles imposed in the name of religious obscurantism and mind and body-controlling authoritarian political ideology,” he said.

This article appeared in the Dallas Voice print edition December 28, 2007

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