A national pro-life group is asking Health Canada to pull an abortion pill off of the market after reviewing the government’s adverse reactions reporting system and finding over one hundred reports of “serious” adverse reactions in connection with the drug protocol.
According to the Health Canada website, there were over 45 “serious” adverse reactions to Mifegymiso, a combination of mifepristone and misoprostol, used to induce an abortion. The drug has been on the market since 2017. One of the reports in Health Canada’s database indicates a 19-year-old woman died after receiving the protocol.
Pete Baklinski, the communications director for Campaign Life Coalition, a pro-life group, told True North in an interview that he hopes the reports lead to Health Canada pulling the drug off of shelves.
“Abortion experts have called (Mifegymiso) the gold standard of medical abortion, saying how safe it was,” Baklinski told True North. “To see the numbers of reports of women who have been harmed by it was quite shocking.”
When looking at the adverse reporting for the two drugs which make up Mifegymiso, Baklinski noticed the side effects reported between all three were identical in some cases.
According to the adverse reporting data, there is a suspected link between mifepristone and the death of a 27-year-old woman, as well as 65 other “serious” adverse reactions.
Health Canada defines a serious adverse reaction as “a noxious and unintended response to a drug, which occurs at any dose and requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death.”
The adverse reactions database, which serves as an early reporting system, was established to warn the public about potentially negative side effects and is sometimes used to remove products from the market if deemed unsafe.
“The data presented reflects, as much as possible, the reporter’s observations and opinions, and does not reflect any Health Canada assessment of association between the health product and the reaction(s),” the interpretation guidelines on Health Canada’s website say. “Inclusion of a particular reaction does not necessarily mean that it was caused by the suspected health product(s). Certain reported reactions may occur spontaneously.”
Even so, Baklinski said the data speak for themselves.
“One woman died after using Mifegymiso. A 19-year-old girl, and so many women who suffered major complications, including infection and sepsis, some of them had near brushes with death,” he said. “The list of harms that women who took misoprostol and mifepristone were exactly the same.”
Joyce Arthur, the executive director of the Abortion Rights Coalition of Canada, disagrees.
“Mifegymiso has a proven safe track record, with a similar safety profile to early aspiration abortion, and both are far safer than full-term pregnancy and childbirth,” she said in a written response to True North. “It is a tragedy if someone dies or is seriously injured due to a drug complication, but there are usually other variables involved that make it hard to pinpoint the cause. Infection is a risk with any gynecological intervention, including childbirth, and can rarely, if ever, be directly attributed to abortion pills.
She noted several other commonly prescribed drugs with a more significant number of side effects and complications, including Viagra, penicillin, and Aspirin.
“Approved drugs are approved for a reason – they are either overwhelmingly safe as is the case for abortion pills, or if they have serious side effects/complications, their life-saving properties are considered far greater, chemotherapy, for example,” said Arthur, who touted abortion drugs as contributing to a “dramatic drop” in maternal mortality rates in countries with restrictive abortion laws, such as in Latin America.
Arthur said there are over one hundred scientific studies that demonstrate the safety of abortion pills.
Nicole Scheidl, the executive director of the pro-life medical association Physicians for Life, said Campaign Life Coalition’s report was “well-researched and highlights many of the problems with the reduction of medical oversight in the provision of chemical abortions.”
Baklinski noted that thalidomide, a drug previously used to combat morning sickness in pregnant women, was pulled off the shelves after over a hundred adverse reactions were reported.
“We have over a hundred women who have suffered near brushes with death. That’s met the threshold for something being unsafe,” he said. “I think that is enough for Health Canada to look seriously at this drug. And to recall it because it’s clearly harming women, and it’s not safe.”
Editor’s note: This article has been updated to correct a number that was erroneously attributed to the Mifegymiso combination rather than misoprostol.