Increased Options For Women Seeking Abortion

Ministry Of Health Increases Options For Women Seeking Abortion

Strict conditions have been set for the use of the abortion pill mifepristone which was today approved for use in New Zealand.

Senior Medical Advisor Dr Stewart Jessamine said mifepristone (also known by its trade name Mifegyne) contains the chemical often referred to as RU486 and as of today was approved as a prescription medicine.

"Mifegyne has been subject to an extensive evaluation process by Medsafe and its expert committee the Medicines Assessment Advisory Comittee".

"Medsafe is satisfied that Mifegyne meets the international standards of safety and effectiveness required for medicines. As Mifegyne was first approved over 10 years ago in France, and has been subject to evaluation by a number of other countries including the United Kingdom, the United States and Sweden, Medsafe's evaluation included not only data from clinical trials but also data and experience collected during use of the product in Europe."

Dr Jessamine said that while the introduction of MIfegyne into New Zealand will add another option for women wishing to have an abortion however, there were strict controls regarding use of this product.

"Although Mifegyne has been approved as a prescription medicine, it will not be available for use by GPs or most other doctors. The Contraception, Sterilisation and Abortion Act requires that abortion can only legally be induced at specially licensed premises. Mifegyne will therefore only be available to clinicians who are licensed under the Act to procure an abortion."

Unlike in some overseas jurisdictions, in New Zealand restrictions placed on medical abortions require women to remain on the specially licensed premises until the abortion has occurred.

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For more information contact: Hayley Brock Media Advisor (04) 496 2115, 025 495 989 www.moh.govt.nz

BACKGROUND INFORMATION

How does Mifegyne work? Mifegyne contains mifepristone, the chemical sometimes called RU486.

Mifegyne produces an abortion by binding to the receptor for the sex hormone progesterone which is responsible for maintaining the lining of the womb during pregnancy. Mifepristone also promotes softening and dilatation of the cervix and sensitises the womb to the actions of other medications which promote contraction of the womb. Once the action of progesterone is blocked, the lining of the womb breaks down and is expelled through the dilated cervix along with the implanted foetus, in a similar fashion to that which occurs during a woman's normal menstrual cycle or spontaneous abortion.

To aid the process, Mifepristone is usually given with another medication called a prostaglandin which stimulates contraction of the womb. When used sequentially, this combination of medications induces abortion in 95% of pregnancies.

Who can be prescribed Mifegyne? Mifegyne is suitable for women up to nine weeks pregnant, but is most effective before seven weeks. It can only be prescribed by clinicians licensed under the Contraception, Sterilisation and Abortion Act. Under the Act abortions can only legally be induced at a specially licensed premises. Mifegyne will not be available for use by GPs or most other doctors.

What is the law regarding Medical Abortion? Medical abortion is permitted under the current Contraception Sterilisation and Abortion Act 1977. The Act however, requires that women who opt for a medical abortion should:

obtain the medications (RU486 and prostaglandin) required to induce the termination of pregnancy from clinicians licensed under Contraception, Sterilisation and Abortion Act; and take these medications at premises licensed to procure an abortion under this legislation; and remain on these premises after administration of the prostaglandin until expulsion of the foetus occurs.

Are there any side-effects from use of this drug? As with all medicines, some women will experience side effects, and others will not. Most commonly, women can expect bleeding, similar to a heavy period, which can last for up to 12 days. Cramping is also common. In some women, the prostaglandin used can cause abdominal pain, nausea and diarrhoea.

Does Mifegyne have any impact on long-term fertility? There are no known effects on long-term fertility and women surveyed in clinical trials overseas have not reported any problems when trying to conceive at a later stage.

Has Mifegyne been approved for use in any other country? Yes. The United State of America approved the drug for use in September 2000. It was approved for use in Britain in 1991 and has been used in France in 1989.

When was the application for approval of this medicine lodged? The application was lodged in June and was referred to the Medicines Assessment Advisory Committee. This committee considers the safety, quality and effectiveness of medicines during the approval process.

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