SEPTEMBER 30, 2005


Still no mifepristone for Canada:
is it safe?

Important new study shows abortion pill
is indeed safe, but cost, political will and
risk of sepsis remain obstacles

Unlike in the US, where they're on everyone's lips as George W Bush makes his controversial Supreme Court appointments, here in Canada abortion rights aren't the hottest of political topics right now. That could be about to change. Mifepristone, aka RU-486 or the abortion pill, is causing quite the uproar as scientists and activists alike are taking sides on its availability and safety for pregnancy termination. But for Canadian doctors and their patients, the point is moot — the drug has yet to be approved here and many believe you can thank the almighty dollar for the hold-up.

Generally speaking, there are two ways to terminate a pregnancy: the traditional surgical method commonly known as vacuum aspiration and the drug-induced, or medical, abortion. With mifepristone unavailable in this country, medical abortions are performed using a combination of methotrexate and misoprostol instead — if you can find a clinic that offers the procedure. Dr Ellen Wiebe, a clinical professor at the University of British Columbia with a full-time family practice in Vancouver, is one of only two Canadian doctors currently performing medical abortions on a regular basis. She estimates that 1-2% of the abortions performed in this country are drug-induced. Interestingly though, the percentage in Vancouver, where women actually have access to the procedure, is closer to 15%. "The reason these women choose medical abortions is that they don't want surgery; some because they feel it is more natural, more private, less invasive, others because they are frightened of surgery," explains Dr Wiebe.

In her opinion, mifepristone has not been approved in Canada because no company has ever submitted an application. It all seems to boil down to numbers. According to Statistics Canada, about 105,000 abortions are performed annually in this country. Of these, only about 25% would be eligible for mifepristone-induced abortion.

But there's much more to this issue than just money. Important safety concerns have been raised as well, both here and elsewhere. In 2001, the only Canadian trial of mifepristone, led by Dr Wiebe, was suspended after the death of a woman from toxic shock brought on by a bacterial infection related to her abortion. Four similar cases have been reported in the US, forcing Danco Laboratories, the US distributor of mifepristone, to add a black box warning on the label about the risks of bacterial infections, sepsis and death. If that weren't enough to raise a red flag, a citizen petition for the withdrawal of the drug from the US market has also been submitted to the FDA.

Danco Laboratories estimates that over two million women worldwide have safely used mifepristone to terminate pregnancy. The drug was first approved over 15 years ago in France, and in 28 other countries since then including the US, Spain, Britain, Sweden, Germany, China and Russia. Since then, extensive data from clinical trials have documented mifepristone's safety and efficacy for induced abortions, but the study published in the September issue of Contraception is the largest and longest to date that examines its routine clinical use. Over 95,000 mifepristone-induced abortions were recorded by the PPFA from 2001 through the first quarter of 2004. Overall, 2.2 per 1,000 women experienced a complication, most commonly heavy bleeding, and mortality was estimated to be 1.1 per 100,000 based on one death.

Until now, no formal link had been established between the reported cases of septic shock and the use of mifepristone. But in a study appearing in the September issue of the Annals of Pharmacotherapy, Dr Ralph P Miech, Professor Emeritus at Brown University, offers evidence of how this rare but devastating reaction may occur. Mifepristone's anti-progesterone effects, which cut off nutrition to the fetus, may also allow the common vaginal bacteria Clostridium sordellii to enter the cervical canal and release toxins into the blood. Meanwhile, the antiglucocorticoid effects of mifepristone inhibit the innate immune system, impairing the body's ability to fight off the infection. This combination sometimes results in widespread septic shock.

C sordellii infections are rare outside of mifepristone use and have proven particularly dangerous because they often lack the usual warning signs, such as fever and abdominal pain. Dr Miech is concerned by his findings, and warns that additional research is necessary to evaluate the risk of infection. "RU-486 has a half-life of about 24 hrs, so it takes about five days for the body to get rid of it," he explains. "I think there's a good possibility that association with infection anywhere in the body during the week after taking the drug is probably under-reported."

So shouldn't we be thanking our lucky stars that we can't get our hands on the stuff? Not so, says the Society of Obstetricians and Gynaecologists of Canada (SOGC). The SOGC has expressed their support of RU-486 for the termination of pregnancy. "The drug is safe and would play an important role in the reproductive rights of women," they wrote in a statement. Dr Wiebe is also confident in her support. "The risk of death from serious infection or other factors is similar with medical or surgical abortions, at less than one in 100,000," she explains. "Mifepristone is much faster than methotrexate and can be used successfully at higher gestations. Women and physicians prefer it when given the choice."



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