Warning for Spermicide Nonoxynol-9
Date of proposal: Jan. 16, 2003
What is proposed:The FDA has proposed new warnings for over-the-counter contraceptives that contain the spermicide nonoxynol-9. The new warning would state that contraceptives that contain nonoxynol-9 do not protect against infection with HIV, the virus that causes AIDS, or other sexually transmitted diseases (STDs).
The proposed warning would also state that the use of vaginal contraceptives that contain nonoxynol-9 can increase vaginal irritation, which may increase the risk of transmitting HIV and other STDs.
The agency is requesting public comment on the proposed labeling changes for the next 90 days, as well as suggestions on the most effective way to present this new warning. Written comments may be sent to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Comments also can be made online.
Basis for warning proposal:Recent studies, including a four-year World Health Organization study of 991 HIV-negative sex workers in Thailand and Africa, show that nonoxynol-9 does not prevent the transmission of HIV.
The spermicide works by damaging the cell membrane of the sperm, and laboratory studies suggests that it may also damage the cells of other organisms, bacteria, and viruses that cause STDs. Based on this data, the FDA believes this membrane-damaging effect can harm the lining of the vagina and cervix, increasing the risk of STD transmission and infection.
Manufacturer: Various
What is proposed:The FDA has proposed new warnings for over-the-counter contraceptives that contain the spermicide nonoxynol-9. The new warning would state that contraceptives that contain nonoxynol-9 do not protect against infection with HIV, the virus that causes AIDS, or other sexually transmitted diseases (STDs).
The proposed warning would also state that the use of vaginal contraceptives that contain nonoxynol-9 can increase vaginal irritation, which may increase the risk of transmitting HIV and other STDs.
The agency is requesting public comment on the proposed labeling changes for the next 90 days, as well as suggestions on the most effective way to present this new warning. Written comments may be sent to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Comments also can be made online.
Basis for warning proposal:Recent studies, including a four-year World Health Organization study of 991 HIV-negative sex workers in Thailand and Africa, show that nonoxynol-9 does not prevent the transmission of HIV.
The spermicide works by damaging the cell membrane of the sperm, and laboratory studies suggests that it may also damage the cells of other organisms, bacteria, and viruses that cause STDs. Based on this data, the FDA believes this membrane-damaging effect can harm the lining of the vagina and cervix, increasing the risk of STD transmission and infection.
Manufacturer: Various
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