FDA warns vaginal contraceptive offers no protection against AIDS

Dec 19 2007

The U.S. Food and Drug Administration has decreed that the over-the-counter vaginal contraceptive and spermicidal product Nonoxynol-9, or N9, must carry a warning about its use.

The FDA says the product's label must warn that N9 does not protect against AIDS, nor does it protect against other sexually transmitted diseases.

Products such as spermicides, gels, foams, films, or inserts containing N9 are used by themselves as forms of contraception.

The FDA says consumers can protect themselves from the transmission of STDs and HIV by abstaining from sex, being in a monogamous relationship with an uninfected partner and by using condoms consistently and correctly.

Dr. Janet Woodcock the FDA’s deputy commissioner for scientific and medical programs, says they have insisted on the warning in order to dispel any misconceptions that the chemical N9 protects against sexually transmitted diseases and HIV infection.

The FDA is demanding that the labels also warn consumers that N9 can irritate the vagina and rectum, which may increase the risk of contracting HIV/AIDS from an infected partner.

The FDA proposed the new warning statements in 2003 and the other labeling information following the results of a major clinical study in Africa and Thailand which showed that women using a contraceptive gel product containing N9 were not protected against HIV and other STDs and were at higher risk for HIV infection than women using a placebo gel.

The FDA says it's action is based on the need to protect the public health and empower consumers to make better informed decisions about the use of these products.