Health Canada postpones ruling on controversial abortion drug

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Health Canada is facing criticism after once again delaying its decision to approve the abortion pill, mifepristone. Also known as RU-486, mifepristone is a drug used to terminate pregnancies in the first 9 weeks of gestation. It works by stopping the supply of progesterone, the hormone that prepares the lining of the uterus for pregnancy. When used in combination with misoprostol, the uterus contracts to expel the fetus, simulating a natural miscarriage.

Abortions completed with medication instead of surgery are better known as medical abortions. Mifepristone is prescribed by a physician, taken at home, and then followed-up by appointment two weeks later to ensure that the abortion is complete.

Mifepristone was first approved in France in 1988 and has since been used by millions of women in over 50 countries including the U.S., U.K., Australia, and New Zealand (Gynuity Health Projects, 2014). It is considered the “gold-standard” for medical abortions and is part of the World Health Organization’s list of essential medicines.

Although the vast majority of abortions in Canada are done surgically, medical abortions are available via methotrexate, an injectable chemotherapy drug prescribed “off-label”. It is considered less effective than mifepristone because it takes longer to work and can lead to serious birth defects if the abortion fails (World Health Organization, 2012).

Yet Canada refuses to give the green-light to this drug and offers little information as to why. Health Canada’s standard drug review process takes a maximum of 300 days but because it requested additional information from the drug’s manufacturer, a ruling has been delayed until later this year.

Linepharma International had originally applied to have its mifepristone tablet approved in October 2011 but was asked to re-submit an application in 2012 after Health Canada demanded more quality documentation. And, just last week, Health Canada announced once again that it was postponing its decision for lack of sufficient data. Should mifepristone be approved in the fall, it would not hit the market until 2016. 

Studies have shown that mifepristone availability doesn’t increase abortion rates but may lead to an increase in the number of abortions performed earlier in pregnancy (Jones & Henshaw, 2002).

There are no legal restrictions in Canada preventing women from receiving medical abortions, however, access to surgical abortions varies significantly across the country. For example, there are no facilities in Prince Edward Island that terminate pregnancies. Mifepristone approval would mean greater access to medical abortion across Canada, especially for women in rural and remote parts of the country.

Opponents have expressed concerns about potential health risks associated with its use, especially fatal sepsis, which has caused several deaths in the U.S.  (U.S. Food and Drug Administration, 2011). According to the FDA, sepsis can occur during any abortion and although approximately 1 in 100 000 woman have died from severe infection, no causal link has been established between medical abortion drugs and the deaths in question.

Overall, it is apparent that there is a lack of transparency in Health Canada’s drug approval process, fuelling speculation about an already controversial topic and reflecting poorly on Health Canada as a consumer protection agency.

For the over 80,000 women per year who opt for abortion in Canada, the best-known option should be easily accessible. Simply put, a less invasive alternative to surgical abortion would allow better, quicker access to care for women in the early stages of pregnancy who choose to exercise their reproductive right.

References

Gynuity Health Projects. (2014). Map of Mifepristone Approvals. Retrieved from http://gynuity.org/resources/read/map-of-mifepristone-approval-en/

Jones, R.K. & Henshaw, S.K. (2002). Mifepristone for Early Medical Abortion: Experiences in France, Great Britain and Sweden. Perspectives on Sexual and Reproductive Health, 34(3). Retrieved from http://www.guttmacher.org/pubs/journals/3415402.pdf

Obert Madundo. (2010). Health Canada in Ottawa [Photograph]. Retrieved from https://www.flickr.com/photos/12973569@N04/16075073577

U.S. Food and Drug Administration. (2011). Mifeprex (mifepristone) Information. Retrieved from http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111323.htm

World Health Organization. (2012). Safe Abortion: Technical and Policy Guidance for Health Systems (2nd ed.). Retrieved from http://apps.who.int/iris/bitstream/10665/70914/1/9789241548434_eng.pdf

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Julie Boucher

Julie obtained her MSc in Interdisciplinary Health Sciences at the University of Ottawa. She is currently the Editor-in-Chief of the IJHS.

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