Health Canada has approved the use of abortion pill RU-486 for up to 49 days gestation with a doctor’s prescription. The agency states that the sponsor of the drug application, Linepharma International Ltd., provided sufficient study data, “risk management measures,” and product labelling.

“This is going to substantially change abortion access in this country for the better,” Sandeep Prasad, executive director of Action Canada for Sexual Health and Reproductive Rights, told CBC News. The organization wants Health Canada to allow other health care providers such as midwives and nurse practitioners to dispense the pill.

“RU-486 is a human pesticide which kills the pre-born child and harms women,” said Jim Hughes, national president of Campaign Life Coalition, in a press release. “We have fought against this drug coming into Canada since 1999 in order to safeguard the health of women and save unborn children from early deaths.” Pro-lifers had hoped that Bill C-17 would stop the approval of RU-486, as the law enacts tough penalties for unsafe drugs and requires that adverse effects be reported.

Mifegymiso (the name of RU-486 in Canada), which contains mifepristone and misoprostol, blocks the action of progesterone on the uterine lining, thereby making the womb inhospitable to the developing child. It also dilates the cervix and causes uterine contractions to expel the baby.

RU-486 has been associated with dangerous and occasionally fatal side effects. In 2001, a Canadian clinical trial of the drug regimen led by abortionist Ellen Wiebe had to be stopped when one patient died eight days after taking the abortion pill from septic shock due to a clostridium infection. In 2011, the U.S. Food and Drug Administration reported that 14 women died since 2006 after taking RU-486 and there were 2,207 adverse events, including 58 ectopic pregnancies, 256 infections, and 339 problems necessitating blood transfusions.

Health Canada’s approval is based on three clinical trials enrolling 934 women in total. The studies found that giving mifepristone followed by misoprostol one to two days later caused abortion in 95.2 to 98.0 per cent of women. The “majority of adverse events” of the pill were described as “transient and mild to moderate in severity,” including vaginal bleeding, pain, cramping, diarrhea, nausea, vomiting, fevers, chills, headaches, dizziness, and weakness.

The release noted that a few patients developed pelvic infections and vaginal hemorrhages, and that “rare cases of fatalities were reported,” but that this will be addressed by “access to emergency care” which “is recommended in the labelling to ensure patient’s safety.” The Health Canada release adds that the safety of the drug is supported by the outcomes in 5356 patients that used the drug in a post-market study.

Linepharma has agreed to develop an education and registration program for prescribers, another safety study, a 24-hour patient-support hotline, a patient consent form, and distribution of Patient Medication Information to address safety concerns with the drug.

The application for Mifegysimo was filed on Nov. 14, 2012. The existence of the application was first revealed by a commentary in the Canadian Medical Association Journal on November 25, 2013. Since then, pro-life advocates have been urging Health Canada to reject the application. Over 3,100 people signed Campaign Life Coalition’s petition against the drug. The theme of the 2014 March for Life, “RU-486, or RU-4LIFE,” was also dedicated to the issue. In April 2014, iPolitics found out that the decision about approval would be delayed until 2015. Despite having the deadline set for mid-January 2015, Health Canada again postponed approval. According to the Globe and Mail, Health Canada has a 300 day standard for first decision on new drugs.

RU-486 will be distributed by Celopharma Inc. and will be on the market by winter 2016.