Issue 34 / 3 September 2012

EARLY medical abortion using low-dose mifepristone and buccal misoprostol is effective, safe and well accepted by women, according to a large observational study published just as the drugs were registered in Australia. (1)

The study, published online by the MJA last Friday, was conducted by Marie Stopes International Australia (MSIA), the not-for-profit women’s health organisation that last week was granted approval by the Therapeutic Goods Administration (TGA) to market and distribute the drug through its subsidiary, MS Health. (2)

The TGA confirmed to MJA InSight that it was “very uncommon” for a non-pharmaceutical company to sponsor a medicine’s registration.

The MJA study examined more than 13 300 early medical abortions at gestations of up to 63 days, which is at a later stage in pregnancy than the 49 days’ gestation stipulated in the drugs’ registration.

It found that clinic-administered mifepristone (200 mg) followed by home-administered buccal misoprostol (800 µg) was associated with a low failure rate (3.5%), low rates of haemorrhage and infection, and was well tolerated.

The study found four cases of known infection and one death from sepsis in a woman who did not return for follow-up despite showing signs of infection.

While mifepristone was not registered in Australia at the time of the study, it could be accessed under the authorised prescriber provisions of the Therapeutic Goods Act. MSIA began accessing the drug through its 15 clinics in 2009.

An MSIA spokesperson said the decision to use mifepristone under the authorised prescriber provisions in women with gestations up to 63 days gestation in their study was based on Royal College of Obstetricians and Gynaecologists’ guidelines, which recommended this timeline along with other data from the medical literature. (3)

Dr Philip Goldstone, MSIA medical director, said about one-third of women requesting an abortion up to 63 days gestation through MSIA clinics opted for the medical method.

“In terms of patient preference, a recent large study of patient preference for medical or surgical termination of pregnancy conducted in France found that when women who contacted a health professional before 56 days of gestation were given a choice between the two methods, 84% of women chose the medical method,” he told MJA Insight. (4)

All women in the MJA study were told of the need for mandatory follow-up to confirm pregnancy termination, and a 24-hour after-care telephone service was available. Those who did not attend for follow-up were telephoned or sent a registered letter, but about 17% of women were lost to follow up.

While the researchers conceded that this “real-world” loss to follow up was higher than had been shown in clinical trial settings, they said that given the emotional nature of abortion, women who felt the termination was successful and who had no physical complications might have been reluctant to return to the clinic.

The researchers reported that the clinic- and home-based nature of the approach made it feasible for use in regional centres in Australia, but noted that its use may be limited in remote areas without access to 24-hour emergency help.

In an editorial in the same issue of the MJA, James Cook University’s Professor Caroline de Costa and Dr Michael Carrette, of Cairns Private Hospital, Queensland, who are also authorised prescribers of mifepristone, welcomed the MSIA research. (5)

However, they raised concerns about the follow-up methods described in the paper.

“When the practitioner providing the abortion is not the person who will provide emergency care for any complications (and we agree with the authors that complications are uncommon), it is mandatory that accessible and well documented prior arrangements are in place for such care”, they wrote. “Access to a telephone helpline alone is insufficient, especially for women in rural areas.”

The authors said not all women requesting early medical abortion were suitable for home abortions.

“Some women in poor economic circumstances and those who cannot find a suitable support person may be better served by surgical abortion”, they wrote.

– Nicole Mackee

1. MJA 2012; 197: 282-286
2. Therapeutics Goods Administration 2012: Media Release: Registration of Mifepristone Linepharma (RU 486) and GyMiso (misoprostol) 30 August
3. RCOG: Late intrauterine fetal death and stillbirth
4. Contraception 2011; 84: 224-229
5. MJA 2012; 197: 257-258

Posted 3 September 2012

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