OTTAWA — Health Canada has approved the use of the abortion pill RU-486, The Huffington Post Canada has learned.
RU-486, also known as mifepristone, will be allowed for use in Canada but can be obtained only through a physician, a senior government source said. The brand name under which it will be sold in Canada is Mifegymiso.
The decision was made Monday and the manufacturer, Linepharma International Limited, notified Wednesday. The drug will be distributed by Celopharma Inc., with commercial availability expected in January 2016. Health Canada has had the application to approve the drug since November, 2012.
Michael Bolkenius, press secretary for Health Minister Rona Ambrose,called the decision “arms-length.”
“Drug approval decisions are arms-length decisions made by Health Canada officials based on analysis by Health Canada scientists,” he said.
Ambrose was informed of the decision. But it’s unclear whether she will weigh in, as she has in another controversial Health Canada decision to allow prescription heroin (diacetylmorphine) as a treatment for addicts in Vancouver.
In the fall of 2013, Ambrose slammed her department’s decision, saying it ran in “direct opposition” to the government’s anti-drug policy, and she announced that the government would close “loopholes” in a special drug access program.
“[I’m] not going to speculate on the reaction,” a government source told HuffPost about Ambrose’s possible actions. Bolkenius declined to comment.
The Harper government has tried to avoid the abortion issue by voting against efforts by its own MPs to revive the question. RU-486 is opposed by social conservative groups such as Campaign Life Coalition, which has fought against its approval for more than 15 years, suggesting it is unsafe and can cause psychological trauma.
On Thursday, the group called on Ambrose and Prime Minister Stephen Harper to stop the distribution of the drug.
“RU-486 is a human pesticide which kills the pre-born child and harms women,” Jim Hughes, Campaign Life Coalition’s national president, said.
He asserted that clinical trials in Canada were halted in 2001 following the death of one woman and that 14 deaths had occurred in the United States from use of the drug.
The National Abortion Federation’s president, Vicki Saporta, said the abortion pill is a safer and more effective way to terminate a pregnancy than the current medical abortion regimen.
“Canadian women would now have access to the gold standard of [medical] abortion care,” she said. “Mifepristone will allow women to access abortions much earlier on in their pregnancies and will help improve access for women in more rural areas, where there may not be a full-time abortion provider in their community,” she added.
Mifepristone is approved in more than 50 countries. It has been approved for use in the United States for about 15 years. It was first licensed in France in 1988.
Mifegymiso will be sold in a pack containing two different drugs. A green box containing one tablet of Mifepristone — a drug used to block a hormone needed for pregnancy to continue — that is taken first. An orange box contains four tablets of Misoprostol which are taken 24 to 48 hours later. Misoprostol causes the uterus to contract and relaxes the opening of the cervix. Vaginal bleeding usually starts a few hours after taking Misoprostol, according to the safety leaflet that will be distributed with the drugs.
Mifegymiso is used only to terminate pregnancies of up to seven weeks (a gestational age of 49 days as measured from the first day of the last period). It will not be prescribed to women with ectopic pregnancies — in which the fetus develops outside the uterus — or women with intrauterine contraceptive devices (IUDs).
Prior to prescribing Mifegymiso, Health Canada states, an ultrasound must be performed. Physicians must also ensure that patients have access to emergency medical care within 14 days of taking mifepristone and must schedule follow-up visits seven to 14 days after taking the drugs to ensure that the pregnancy has been terminated. If the pregnancy continues, birth defects can occur.
Clinical studies suggested a failure rate of 2 to 4.8 per cent, Health Canada states.
The most frequent side effects are vaginal bleeding, cramping nausea, vomiting, diarrhea, abdominal pain and cramping. On average, bleeding lasts 11 days, according to Health Canada. Some patients reported bleeding seriously enough to require a blood transfusion. Infectious complications such as sepsis have also been observed.
Linepharma International Limited has agreed to develop an education and registration program for prescribers and a post-approval observational safety study. It will also set up a patient support line. Patients will have to give their written consent before taking the drug.
It is not intended to be used as routine contraception.
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REALITY: Over 99.75 percent of abortions do not cause major medical problems. Less than one-quarter of 1 percent of abortions performed in the United States lead to major health complications, according to a 2014 study from the University of California, San Francisco, that tracked 55,000 women for six weeks after their abortions. The researchers note that this makes an abortion statistically about as risky as a colonoscopy. If that fact seems surprising, consider how American pop culture misrepresents the risks of abortion: Nine percent of film and television characters who have abortions die as a direct result of the procedure, according to another 2014 study from UCSF.
REALITY: About one in five abortions are medical abortions. The Centers for Disease Control and Prevention found that 19 percent of abortions in 2011 were medical abortions and that 28.5 percent of those took place in the first nine weeks of pregnancy. The Guttmacher Institute also found that medical abortions increased substantially from 2008 to 2011, meaning more women have ended their pregnancies with this alternative to surgery.
REALITY: Most women will not regret their decision, and are no more likely to experience mental health problems than women who carry an unplanned pregnancy to term. While many women experience mixed emotions after an abortion, 95 percent of women who have abortions ultimately feel they have made the right decision, according to an August 2013 study from UCSF. "Experiencing negative emotions postabortion is different from believing that abortion was not the right decision," the researchers explained. Furthermore, while unplanned pregnancies often cause emotional stress, there is no evidence to suggest that women who choose to terminate their pregnancies will be more likely to suffer from mental health issues, according to a 2008 report from the American Psychological Association that investigated all relevant medical studies published since 1989. The APA found that past studies claiming abortion causes depression and other mental health problems consistently failed to account for other risk factors, particularly a woman's medical history. The APA accounted for these factors and found that, among women who have an unplanned pregnancy, those who have abortions are no more likely to experience mental health problems than those who carry the pregnancy to term.
REALITY: Fetuses cannot feel pain until at least the 24th week of pregnancy. Experts ranging from Britain’s Royal College of Obstetricians and Gynaecologists to the American Congress of Obstetricians and Gynecologists agree with that timeline. In fact, research from UCSF found that fetuses can't perceive pain before 29 or 30 weeks of development. Then why have so many states banned abortions after 20 weeks of pregnancy? Perhaps misrepresentation of research is partly to blame: Many of the researchers most frequently cited by pro-life politicians told The New York Times that their research does not prove anything about fetal pain.
REALITY: Most Americans support a woman's right to choose. According to a Gallup poll from 2014, 78 percent of Americans think abortion should be legal in some or all circumstances. (Fifty percent said "some circumstances," while 28 percent said all.) What's more, in 2012, Gallup found that 61 percent of Americans think abortions that take place during the first trimester of pregnancy should be legal. (Nine out of 10 abortions in the U.S. do take place during that time period, according to Guttmacher.)
REALITY: The abortion rate in the United States is the lowest it's been since 1973. The abortion rate has been on the decline for years, and hit its lowest level in 2011, according to the latest data available from the Guttmacher Institute. The study's author partially credited the decline to better contraceptive use and more long-term contraceptive options, such as the IUD.
REALITY: Women face a growing number of barriers to accessing abortions. More than 57 percent of American women live in states that are hostile or extremely hostile to abortion rights, according to the Guttmacher Institute. That represents a marked increase from 2000, when 31 percent of American women lived in such states. In 2011, 89 percent of counties in America had no abortion clinics. This is no accident: Across the U.S., lawmakers have enacted 231 new abortion restrictions over the past four years, according to a Guttmacher analysis from January 2015. As a result, many women have to travel great distances to reach an abortion clinic, where they may face 24-hour wait periods. These barriers particularly affect women living in rural areas and low-income women, who often can't afford to take time off work and pay for gas and a hotel room. Other laws force women to go through potentially distressing procedures, such as viewing their own ultrasound photos, in order to move forward with an abortion.
REALITY: Women rarely cite pressure from family or partners as leading to their decision to abort. A 2005 study from the Guttmacher Institute found that less than 1 percent of women surveyed cited such pressure among their main reasons for having an abortion. A 2013 study from UCSF reached a similar conclusion, and found that while women rarely cited partner coercion as a reason they sought an abortion, many did cite the desire to escape a bad relationship or domestic violence.
REALITY: Most women who have abortions are already mothers. Sixty-one percent of women who had abortions in 2008 were mothers, and 34 percent had two or more children, according to the Guttmacher Institute. That number only increased after the 2009 financial downturn. The National Abortion Federation told Slate that between 2008 and 2011, 72 percent of women seeking abortions were already mothers. A study from Guttmacher found that mothers typically have abortions to protect the children they already have; they simply cannot afford to raise another child.
REALITY: Requiring abortion clinics to meet these standards does little to improve patient safety and forces many to shut down. Currently, 22 states require abortion clinics to meet a set of restrictive and often arbitrary standards, dictating that they be close to hospitals and that their hallways and closets meet certain measurements. Clinics often need to undergo expensive renovations in order to comply, and leading doctors' groups say the laws do little to improve patient safety. What's more, 11 states now require that doctors at abortion clinics obtain admitting privileges at a nearby hospital, but many hospitals flat-out refuse to grant these privileges. As a result, hospitals essentially have the power to shut down nearby clinics.