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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