The risks of Nonoxynol-9

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The risks of Nonoxynol-9

Its a popular over-the-counter contraceptive used by millions of women. Now, the government and leading health officials are warning: Nonoxynol-9 may increase your risk of contracting a sexually transmitted disease, including H-I-V, if you use it frequently.

The F-D-A is proposing warning labels on all products containing Nonoyxnol-9. Several groups, including Planned Parenthood and the National Aids Council, are no longer giving out condoms with N-9, yet they still fill the shelves in every corner drugstore!

Its a popular ingredient in many over-the-counter contraceptives used by more than a million American women. Its in everything from contraceptive foams, gels, even condoms.

Now, the government, scientists and leading health officials are warning: Nonoxynol-9 (N-9) may increase your risk of contracting sexually transmitted diseases, including HIV, if used frequently.

The FDA is now proposing warning labels on all vaginal contraceptives containing N-9, and is discussing whether condoms should contain warnings as well.

Recently, the Food and Drug Administration (FDA) proposed new warning labels for all over-the-counter (OTC) vaginal contraceptive products containing Nonoxynol-9 (N-9).

These warning statements would advise consumers that vaginal contraceptives containing Nonoxynol-9 do not protect against:

  • Infection from the human immunodeficiency virus (HIV), the virus that causes AIDS
  • Other sexually transmitted diseases (STDs)

The proposed labels also warn that frequent use of vaginal contraceptives containing Nonoxynol-9 can increase vaginal irritation. Increased vaginal irritation from use of Nonoxynol-9 may increase the possibility of transmission of the AIDS virus (HIV) and STDs from infected partners.

According to the FDAs proposal:

  • Nonoxynol-9…works as a vaginal contraceptive by damaging the cell membrane of sperm. It has been shown in certain studies to damage the cell wall of certain STD pathogens and to have activity against certain bacterial and viral STD pathogens, including HIV.
  • However, based on data the agency believes that this same cell membrane damaging effect can damage the vaginal and cervical epithelium (cell lining.) Thus, Nonoxynol-9 can have a negative impact on the vaginal lining and may increase the user's risk of getting STD/HIV and other genital infections.

Condoms are not included in the current FDA label proposal, although the agency is in discussions about whether condoms should contain warnings as well.

The Center for Disease Control and Prevention also urges people at high risk of STDs (i.e., those not in a monogamous relationship) to avoid contraceptive products with nonoxynol-9.

The World Health Organization:

On June 28, 2002, the World Health Organization (WHO) issued revised public health guidelines for the use of Nonoxynol-9 for HIV and STD prevention and for pregnancy prevention in populations at high risk for HIV. The guidelines were based on a review of current clinical safety and effectiveness data on Nonoxynol-9.

The WHO guidelines advised that:

  • spermicides containing Nonoxynol-9 do not protect against HIV infection and may even increase the risk of HIV infection in women using these products frequently.

The guidelines also advised women at high risk of HIV infection against using Nonoxynol-9 spermicide for contraception.

The study: Considerable research has been undertaken on the safety and effectiveness of Nonoxynol-9 for HIV prevention. A large multi-country study sponsored by the World Health Organization (WHO) and conducted by UNAIDS, reported preliminary results in July 2000 and the final report was published in The Lancet in September 2002.

The study, which was conducted by Dr. Lut Van Damme, showed that women using Nonoxynol-9 had a higher incidence of HIV infection than women using a placebo gel.

Prompted by the data, the WHOs Department of Reproductive Health and Research, in partnership with the CONRAD (Contraceptive Research and Development Program) convened a Technical Consultation in October 2001 to review the implications of the new data on the use of Nonoxynol-9 as a spermicide.

Some key conclusions from the Technical Consultation include:

  • Nonoxynol-9 offers no protection against sexually transmitted infections such as gonorrhoea or Chlamydia.
  • There is no evidence that condoms lubricated with Nonoxynol-9 are any more effective in preventing pregnancy or infection than condoms lubricated with silicone, and such condoms should no longer be promoted.
  • Although Nonoxynol-9 has been shown to increase the risk of HIV infection when used frequently by women at high risk of infection, it remains a contraceptive option for women at low risk.
  • There was an increase in the risk of HIV among women who were using Nonoxynol-9… Nonoxynol-9 causes irritation. Irritation means you are more sensitive to being infected with HIV. Definitely the product is not preventing you from getting HIV.  says Dr. Van Damme.

Dr. Van Damme adds that, it is a good idea that the Food and Drug Administration is proposing warning labels.

N-9 companies say they are committed to protecting customers

Johnson and Johnson, the maker of the Ortho Options line of contraceptives, says its products are designed and marketed for pregnancy protection, not infection prevention, and will follow any safety requirements to keep users safe. The company says:

  • As always we will work with the FDA to continue offering safe, effective, over-the-counter, non-hormonal birth control options. All Ortho Options products will include any label changes deemed necessary by the FDA to ensure the safety of the women who use them.

The maker of Trojan condoms says N-9 offers an important option for some users. The company says

  • Armkel, the maker of Trojan condoms, is committed to supporting and protecting the public health through responsible public health policy.
  • Among sexually active individuals, condoms are a very effective means to prevent unwanted pregnancy and the only means available to reduce the risk of getting sexually transmitted diseases, including HIV/AIDS.
  • The Trojan brand offers a variety of condoms. Some of these condoms are lubricated with the spermicide nonoxynol-9 (N-9). N-9 has been used as an effective spermicide for over 50 years and has been used on condoms for over 15 years. Condoms lubricated with N-9 offer an important option for family planning where pregnancy protection is the primary need. Many consumers prefer the extra measure of pregnancy protection that N-9 spermicidal lubricant is intended to provide.
  • In light of our commitment to protecting the public health, we feel consumers should be allowed to choose the products that best meet their needs. We are currently working with the FDA on revised labeling for condoms lubricated with the spermicidal N-9 to ensure they are used appropriately.

Be informed, but not alarmed.

Dr. David Soper is Vice Chairman and Professor of OB-GYN at the Medical University of South Carolina.

He says, If [irritable symptoms] were to be noticed by patients using N-9, our recommendation would be for them to stop using the product and for them to call their doctor and possibly be examined for any evidence of inflammation of the lower genital track,

Occasional use OK?

He adds, When I council patients about the use of N-9, currently given this new information, I'm recommending that they use N-9 less than once per day. By decreasing the frequency of use, they decrease their risk of having an adverse reaction to the topical contraceptive and decrease their risk for inflammation and ulcer formation.

He says not everyone needs to be alarmed. If you are using N9, just make sure you are using it infrequently and everything should be fine.

My best advice to patients that are using N-9 now for contraception is to seek the advice of their health care provider.