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RU486 abortions approved in Australia: Regrettable and dangerous 31 Aug 2012

Renate Klein

RU486 abortions approved in Australia: Regrettable and dangerous

Yesterday’s announcement by the Therapeutic Goods Administration that it has approved an application by the private company MS Health, set up by Marie Stopes International (MSI), to import the abortion drug RU486 does not come as a big surprise. It has been on the cards ever since the vote in Federal Parliament in 2006 that stripped the Health Minister of the day of their veto over a potential application by a pharmaceutical company.

What’s more, proponents of RU486 such as Professor Caroline de Costa from Cairns, have regularly announced that an application by a pharmaceutical company to import RU486 was imminent. Now it’s not a pharmaceutical company that lodged an application but a private company set up by MSI, an abortion ‘chain’ with a number of clinics in Australia (one branch in Croydon was recently closed down after dozens of women had been infected with hepatitis and a woman had died after an abortion in 2011, no details revealed).

As a feminist long-time women’s health researcher who supports women’s access to safe pregnancy terminations, this decision by the TGA begs many questions. Documentation for the safety and effectiveness which I hope MSI had to submit to the TGA to obtain approval would have to be based on overseas research since no large scale trials on RU486 have been conducted in Australia. Is this good enough for Australian women?

Also, until now, RU486 - and the second drug, a prostaglandin (PG Misoprostol, Cytotec™) which by the way has never been approved for use in abortions by its manufacturer (Pfizer, formerly Searle) - could only be used by medical practitioners after obtaining an authorized prescriber license from the TGA. Indeed, Professor de Costa who was the first to obtain such a license reported that the combination RU486/PG had strict conditions imposed: only women with life-threatening or otherwise serious health conditions such as kidney disease, high blood pressure and other heart conditions for whom a suction abortion was deemed unsafe, could be administered RU486/PG.

But these strict conditions gradually fell away, notably by MSI Australia clinics who two years ago sent a brochure to Victorian GPs suggesting they refer women who wanted pregnancy terminations to one of their clinics without any mention of restricted use or review requirements by the TGA.

When the first death of a woman in Australia from RU486/PG in 2010 was reported on 19 March this year - a two year delay -in The Australian, the TGA issued new guidelines for follow-up care to clinics using the abortion pill ( We know few details about this death other than that the woman died from sepsis after the abortion. The coroner did not order an Inquiry which is most unfortunate given that this was the first reported case of a woman dying in Australia from RU486/PG abortion.

RU486/PG abortions overseas have resulted in a number of women dying where sepsis was the cause of death (the bacterium Clostridium was identified in uterus infections in the USA, UK and Sweden). Other women have died from severe blood loss when no medical facilities were available for blood transfusion.

Promoters of medical abortions led us to believe that RU486/PG abortion is more ‘natural’ than suction abortion and that it is ‘just like a miscarriage’ and safe. This is twisting the truth more than a little bit! Women who have used this method tell other stories. The vomiting, pain and nausea can be close to unbearable and as one woman who had a recent RU486/PG termination in South Australia told me she got such a high fever combined with extreme blood loss that she feared for her life. She would certainly never do it again.

The RU486/PG combination also has a lower success rate than suction abortion: depending on which figures you quote between 91% and 93%; suction abortion succeeds in 99%. (I actually prefer to call RU486/PG a ‘chemical’ rather than a ‘medical’ abortion which sounds so benign compared to ‘surgical’ abortion, a misnomer as nothing is ‘cut’ in a suction abortion.)

Importantly also, once she has swallowed the RU486 pills (and the prostaglandin 2 days later), the woman is entirely on her own. Some women have instant adverse reactions, but for others, the blood loss or pain from uterine contractions may start only days into the procedure. The point is that it is entirely unpredictable in which women the termination will happen without problems or lead to possibly fatal complications.

Instead of being looked after in an abortion clinic should complications occur and having the suction abortion finished in half an hour, RU486/PG abortions can take as long as six weeks! It is absolutely crucial that women go back to doctors for a check-up to make sure the abortion is complete. If it is not, a D&C is required, the most frequently reported adverse effect (442 instances as reported by Jamie Walker in the article quoted earlier).

Surely this abortion method is not the panacea that its promoters hail it to be. We know that many women feel ambivalent about having an abortion. They make this often painful decision because they can not see a way to rear a(nother) child. Having to physically experience the consequences of their decision with ongoing pain, nausea and blood loss for weeks is surely inhumane punishment. In some instances the women find the small embryo passed out in their sanitary pads…even a person who supports a woman’s right to abortion would find this most upsetting and sad.

Promoters hail RU486/PG as a breakthrough especially for women who live in rural and isolated parts of Australia. But given the potential of life-threatening complications with no nearby hospital for emergency procedures, I consider this irresponsible and reckless. It is true that abortion facilities are hard to access but I believe that it is the medical system’s responsibility to provide safe abortions, instead of writing prescriptions for pills - to be filled in pharmacies and taken later: in my books this is the 21st century version of backyard abortions and women deserve better.

For all of these reasons I certainly was not popping champagne yesterday. Marie Stopes’ use of RU486/PG abortion in Australia requires careful monitoring and reporting and the TGA must put these requirements in place. And as MSI’s prostaglandin registered with the TGA is Gymiso™ (used in France) rather than the usual Cytotec™, this needs attention as well.

As for considering inclusion in the Pharmaceutical Benefits Scheme, this is a question that should not even be asked at this point.

This is an extended version of an article published 30 August 2012 at

Dr Renate Klein is a feminist-long term women’s health researcher and together with Janice Raymond and Lynette Dumble coauthored RU486: Misconceptions, Myths and Morals, available from Spinifex Press in print and as an eBook.   


Associated Author: Renate Klein


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