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

The RU-486abortion pill has been approved for prescriptionuse in Canada, some25 years after it was made available for women in France, andafter a 2-yearreview by Health Canada.

Here's what you need to know about RU-486, manufactured byLinepharma 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 provideanotheroption, which is easier to access, toterminating a pregnancy.

Canada has no legal restrictions on abortions, butaccess 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 pillwork?

In Canada, the pillwill be marketed asMifegymiso.

RU-486 is commonlyreferred to as justmifepristone, but it is reallya two-drug combinationofmifepristone and misoprostol. A woman will takemifepristone, which blocks the production of progesterone, a hormone that prepares the uterine lining for pregnancy, and then a day or twolatertakes the drug misoprostol, which causes contractions, essentially inducing a miscarriage.

Is it different from the morning-after pill?

Themorning-after pill is an "emergency contraceptive," to be used within 72 hours,topreventan egg from fertilizationafter intercourse, orstopa fertilized egg from attaching to the uterus. By the time afertilized eggattaches,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-486safe?

Canadian Physicians For Life raised concerns about the drug's side-effects, pointing toreports 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 saiddrugmaker 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 deathspossibly linkedto RU-486, and said infectionis 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 sepsisin 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.

Whydid approval in Canada take so long?

It took Health Canada 2years to OK the abortion pill, much longer than thenine months it usually takes for pharmaceuticals to work their way through the approvals process. The drug was licensed in France in 1988, andapproved for use in the United States in 2000.

• Abortion drug decision pushed back by Health Canada

In January 2015, Health Canada's approval decisionwas pushed back as the government agencyrequested 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," LeslieMeerburg, a Health Canada spokesmansaid,when asked about the delay.

How do you get it?

Canadianwomen will need to see their doctors to obtaina 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 nursepractitioners, 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 onemifepristone-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 CelopharmaInc. and is expected to be available for sale inwinter 2016, saida statement from the drug's manufacturer.