UNITED STATES: FDA to Add HIV Warning to Contraceptive Products

Important note: Information in this article was accurate in 2007. The state of the art may have changed since the publication date.

UNITED STATES: FDA to Add HIV Warning to Contraceptive Products

Reuters (12.18.07) - Wednesday, December 19, 2007
Kim Dixon

On Tuesday, the Food and Drug Administration (FDA) announced a rule requiring makers of over-the-counter nonoxynol 9 (N9) contraceptive products to warn consumers that the products do not protect against STDs, including HIV.

"FDA is issuing this final rule to correct the misconceptions that the chemical N9 in these widely available stand-alone contraceptive products protects against sexually transmitted diseases," Janet Woodcock, FDA's deputy commissioner for scientific and medical programs, said in a statement.

FDA suggested the notice in 2003 after a large study of women in Africa and Thailand found those using an N9 gel were not protected from STDs, and in fact were at more risk for HIV than women given a placebo.

N9-containing contraceptive products such as gels, foams, films, and inserts will carry a warning that they can irritate the vagina and rectum, possibly increasing the risk of HIV infection.
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