Drugs Xagena
The FDA ( Food and Drug Administration ) has required that manufacturers of over-the-counter ( OTC ) stand-alone vaginal contraceptive and spermicidal products containing the chemical ingredient Nonoxynol 9 ( N9 ) include a warning that the chemical N9 does not provide protection against infection from HIV or other sexually transmitted diseases ( STDs ).
Stand-alone spermicides include gels, foams, films, or inserts containing N9 that are used by themselves for contraception. Consumers can protect themselves from the transmission of STDs and HIV by practicing abstinence, being in a monogamous relationship where neither partner is infected, and using condoms consistently and correctly.
In addition, FDA is requiring that the labels warn consumers that the chemical N9 in stand-alone vaginal contraceptives and spermicides can irritate the vagina and rectum, which may increase the risk of contracting HIV/AIDS from an infected partner.
In January 2003, FDA proposed new warning statements and other labeling information for these products after results from a major clinical study in Africa and Thailand 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. Because these and other studies have shown that use of products containing N9 cause vaginal and rectal irritation, which can heighten the chance of becoming infected with HIV from an infected partner, FDA'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.
This rule is being finalized following a public comment period and a thorough analysis of information and views from consumers, health care providers, academicians and industry.
FDA is requiring that labeling of OTC vaginal contraceptive/spermicidal products containing N9 bear the following warnings.
Source: FDA, 2007
XagenaMedicine_2007
