RU-486: What you need to know about the recently approved abortion pill

Here's what you need to know about the RU-486 abortion pill, which has been approved for use in Canada by prescription after a lengthy regulatory review.

Health Canada approves abortion pill 2½ years after drugmaker's application

The abortion-inducing drug RU-486, actually a two-pill therapy, has been approved for use in Canada. (Charlie Neibergall/Canadian press)

The RU-486 abortion pill has been approved for prescription use in Canada, some 25 years after it was made available for women in France, and after a 2½-year review by Health Canada.

Here's what you need to know about RU-486, manufactured by Linepharma International Limited:

Why is this decision important?

With controversy in some parts of Canada over access to abortions, proponents of the abortion pill argue it would provide another option, which is easier to access, to terminating a pregnancy. 

Canada has no legal restrictions on abortions, but access to surgical abortions varies by region. One in six hospitals in Canada provide abortions, and most of those are in urban areas, says Sandeep Prasad, executive director of Action Canada for Sexual Health and Rights.

"This is going to substantially change abortion access in this country for the better," Prasad told CBC News.

How does the abortion pill work? 

In Canada, the pill will be marketed as Mifegymiso. 

RU-486 is commonly referred to as just mifepristone, but it is really a two-drug combination of mifepristone and misoprostol. A woman will take mifepristone, which blocks the production of progesterone, a hormone that prepares the uterine lining for pregnancy, and then a day or two later takes the drug misoprostol, which causes contractions, essentially inducing a miscarriage.

Is it different from the morning-after pill?

The morning-after pill is an "emergency contraceptive," to be used within 72 hours, to prevent an egg from fertilization after intercourse, or stop a fertilized egg from attaching to the uterus. By the time a fertilized egg attaches, it's too late to take the morning-after pill. RU-486 is for use only within the first 49 days of pregnancy, according to Health Canada.

Is RU-486 safe?

Canadian Physicians For Life raised concerns about the drug's side-effects, pointing to reports of fatal sepsis, or infection, in the U.S.

"No drug is without risk, but the risks associated with RU-486 are well known," Dr. Laura Lewis, an Ontario family physician and a Canadian Physicians for Life board member, said in a statement.

 "When we consider this will make abortion more accessible to women living in remote areas, we need to remember that due to the drug's possible adverse effects, women using this drug will still need proper medical followup."

In its regulatory decision summary about RU-486, Health Canada said drugmaker Linepharma has agreed to develop "an education and registration program for prescribers and a post-approval observational safety study."

"Additional risk management measures include a 24-hour patient support line, a patient consent form and distribution of patient medication information to be provided to each patient," Health Canada said.

In 2011, the U.S. Food and Drug Administration addressed concerns of previous deaths possibly linked to RU-486, and said infection is a risk related to any abortion procedure.

"We do not know whether using mifepristone and misoprostol caused these deaths," the FDA said in a fact sheet posted on its website. "Reports of fatal sepsis in women undergoing medical abortion are very rare."

A 2007 study in the New England Journal of Medicine compared 2,710 women who had an RU-486 abortion to 9,104 women who had a surgical abortion and found no increased risk of ectopic pregnancy, miscarriage, pre-term birth, or low-birth-weight babies  in subsequent pregnancies.

"Mifepristone has been safely and effectively used by millions of women worldwide to terminate an early pregnancy since 1988, and is available in 60 other countries," the National Abortion Federation said in a statement.

Other known side-effects, according to the U.S. National Institutes of of Health, include:

  • Cramps.
  • Pelvic pain.
  • Vaginal burning, itching, or discharge.
  • Headaches.
  • Tiredness.
  • Difficulty falling asleep or staying asleep.
  • Anxiety.
  • Back or leg pain.

Why did approval in Canada take so long?

It took Health Canada 2½ years to OK the abortion pill, much longer than the nine months it usually takes for pharmaceuticals to work their way through the approvals process. The drug was licensed in France in 1988, and approved for use in the United States in 2000.

In January 2015, Health Canada's approval decision was pushed back as the government agency requested additional information from the drug's manufacturer.

"Timing for the review of drug submissions varies depending on the information provided by the manufacturer, as well as whether or not requests for additional information or clarification are needed," Leslie Meerburg, a Health Canada spokesman said, when asked about the delay. 

How do you get it?

Canadian women will need to see their doctors to obtain a prescription.

Action Canada for Sexual Health and Rights said it hopes Canada will eventually follow the World Health Organization's recommendation that health-care providers other than doctors — midwives and nurse practitioners, for example — be allowed provide the pill.

Having a medical abortion using RU-486 in Canada will involve two visits to the doctor. On the first visit, the patient takes one mifepristone-misoprostol combination pill under doctor supervision. At home, they take four more within 12 to 24 hours. The patient returns for a post-treatment examination within one to two weeks.

RU-486 will be distributed in Canada by Celopharma Inc. and is expected to be available for sale in winter 2016, said a statement from the drug's manufacturer.

With files from The Canadian Press


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