FDA to add HIV warning to contraceptive products

WASHINGTON (Reuters) - U.S. regulators on Tuesday finalizeda rule requiring makers of certain contraceptive gels, foams,films and inserts to carry a warning that the products do notprotect against sexually transmitted diseases, including AIDS.
The U.S. Food and Drug Administration will require thewarning on over-the-counter products containing nonoxynol 9,used in many stand-alone spermicides.
"FDA is issuing this final rule to correct themisconceptions that the chemical N9 in these widely availablestand-alone contraceptive products protects against sexuallytransmitted diseases," Janet Woodcock, FDA's deputycommissioner for scientific and medical programs, said in astatement.
The FDA proposed the warning in 2003, after results from alarge study in Africa and Thailand found women using acontraceptive gel were not protected against HIV and othersexually transmitted diseases and were at a higher risk of HIVthan those on a placebo.
The new FDA warning states that because the products canirritate the vagina and rectum, they may boost the risk ofacquiring HIV/AIDS. A skin irritation may boost the chance ofinfection as the virus has more ways to invade the body.
(Reporting by Kim Dixon; Editing by Jeffrey Benkoe)