WASHINGTON (Reuters) - U.S. regulators on Tuesday finalized a rule requiring makers of certain contraceptive gels, foams, films and inserts to carry a warning that the products do not protect against sexually transmitted diseases, including AIDS. The U.S. Food and Drug Administration will require the warning on over-the-counter products containing nonoxynol 9, used in many stand-alone spermicides.
WASHINGTON (Reuters) - U.S. regulators on Tuesday finalized a rule requiring makers of certain contraceptive gels, foams, films and inserts to carry a warning that the products do not protect against sexually transmitted diseases, including AIDS.
The U.S. Food and Drug Administration will require the warning on over-the-counter products containing nonoxynol 9, used in many stand-alone spermicides.
"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.
The FDA proposed the warning in 2003, after results from a large study in Africa and Thailand found women using a contraceptive gel were not protected against HIV and other sexually transmitted diseases and were at a higher risk of HIV than those on a placebo.
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The new FDA warning states that because the products can irritate the vagina and rectum, they may boost the risk of acquiring HIV/AIDS. A skin irritation may boost the chance of infection as the virus has more ways to invade the body.
(Reporting by Kim Dixon; Editing by Jeffrey Benkoe)
