Isotretinoin Use Amongst Women of Reproductive Age and the Risk of Pregnancy and Adverse Pregnancy Outcomes

Project number: 
Approval date: 
Tuesday, February 18, 2014
Principal Investigator: 
University of British Columbia (UBC)
Funding Agency: 
Canadian Institutes of Health Research(CIHR)
Datasets requested: 
Hospital Separations (BC Ministry of Health)
Births (BC Vital Statistics Agency)
Consolidation - demographic (Ministry of Health)
Medical Services Plan (BC Ministry of Health)
Deaths (BC Vital Statistics Agency)
Consolidation registry (Ministry of Health)
Stillbirths (BC Vital Statistics Agency)
MSP Registration & Premium Billing(BC Ministry of Health)
consolidation - census geocodes
Research objective: 

Isotretinoin and the risk of pregnancy and adverse pregnancy outcomes

The objectives of this study are to:

1) Estimate trends and patterns of isotretinoin use amongst women and men before and after the launching of the Pregnancy Prevention Program (1989), stratifying on health care coverage,

2) Quantify the incidence of pregnancy amongst women using isotretinoin,

3) Quantify the risk of abortions (spontaneous or therapeutic/planned), stillbirths, neonatal death, and major congenital malformations associated with isotretinoin use during pregnancy,

4) Determine the appropriateness of isotretinoin use in women by:
a) determining the indications (using indication markers) for isotretinoin use,
b) estimating the proportion of women on concomitant isotretinoin and oral contraceptive (OC) therapy,
c) estimating the proportion of isotretinoin users with a positive pregnancy test or procedures related to pregnancy within 15 days of any isotretinoin prescription,
d) estimating the proportion of positive pregnancy test or procedures related to pregnancy within one month after isotretinoin termination.

5) Determine women and physician characteristics that are associated with isotretinoin management and pregnancy, and thus identify women at risk of becoming pregnant while on isotretinoin.


1. We hypothesize that the difference in rates of isotretinoin prescriptions before and after the launching of the PPP will depend on the Program guidelines but also on the incidence of cystic recalcitrant acne in the population and on the evolution of the management. Thus, a cohort of men will also be assembled to measure and adjust for the trend in the baseline rate of isotretinoin use and incidence of cystic recalcitrant acne over time.

2. We hypothesize that if women were appropriately managed by their treating physician while they are taking isotretinoin, the rate of pregnancy should be close to null as reported with the iPledge program in the US.


Journal Publication

  • David Henry, Colin Dormuth, Brandace Winquist, Greg Carney , Shawn Bugden, Gary Teare, Linda E. Lévesque, Anick Bérard, J. Michael Paterson, Robert W. Platt. (2016) “Occurrence of pregnancy and pregnancy outcomes during isotretinoin therapy” CMAJ April 25, 2016 First published April 25, 2016, doi: 10.1503/cmaj.151243

Page last revised: January 21, 2020