The Canadian Press - ONLINE EDITION
Best abortion option not available in Canada, says commentary urging drug approval
TORONTO - Canadian women lack access to the best known option for abortion, two reproductive medicine experts argued in a commentary published Monday by the Canadian Medical Association.
The authors said Health Canada is currently studying an application to bring that option, a drug commonly known as RU-486, to the Canadian market.
"The results of the submission are pending," family physician Sheila Dunn and law professor Rebecca Cook wrote. "It is important that this submission not be allowed to fail."
Health Canada declined to comment on whether it is assessing an application to market the drug in Canada.
"Health Canada is bound by laws preventing disclosure of confidential information that is proprietary to the respective manufacturer," the department said in an emailed reply to questions.
"Once a submission is received, its existence or non-existence within the department remains confidential, proprietary information until it is approved."
Mifepristone — the generic name for RU-486 — has been available for more than two decades in France, where the drug was invented. It has been available in Britain since 1991 and in the United States since 2000. Women in 57 countries have access to the drug.
It is used in combination with another medication already approved for other indications in Canada. The treatment essentially induces a miscarriage, avoiding the need for a surgical abortion in most cases.
It can be used within the first nine weeks of a pregnancy.
In Canada, a different combination of drugs is sometimes used to induce a so-called medical abortion — meaning it doesn't involve surgery. But that combination can only be used within a seven-week window — and it isn't as easy to administer. Some abortions only occur several weeks after the drugs are taken, requiring more medical followup to ensure the drugs were effective.
As well, the main drug in the currently available therapy is teratogenic — meaning it can cause birth defects when taken during pregnancy. So if the drugs fail to terminate the pregnancy, the resulting child may be born with serious deformities, Cook and Dunn wrote.
It's not clear why mifepristone isn't available in Canada. If the manufacturers had applied for a licence in the past and had been turned down, that would not be publicly available information.
But it is also possible that because of the relatively small size of the Canadian market no one has tried to introduce the drug here, Dunn and Cook acknowledged.
"We don't ever know the reasons that people have for not bringing drugs into different countries," said Dunn, a family doctor who specializes in reproductive medicine at Toronto's Women's College Hospital.
"Some of them will be economic. And sometimes if it's going to be really onerous to actually get drug approval and the economic margins are not going to be such that makes it worthwhile for someone to do that, that may be a deterrent."
There were clinical trials of the drug in Canada early in the last decade. But one was stopped after a woman who received the drug died of a bacterial infection.
Several other such deaths were reported in the United States and Europe, Dunn said. Investigations could find no explanation for the cluster of what are normally rare infections, she said, adding that there have been none in recent years.
Millions of women have used mifepristone safely to terminate early pregnancies, she and Cook, a law professor at the University of Toronto, said in their commentary.
Approval of the drug would improve access to abortion in parts of the country where women currently have to travel long distances for a surgical procedure, they argued, and would free up operating room time.
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(1 of 7 articles for this year)03/31/2015 4:01 PM 0
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