Isotretinoin, Contraception, and Pregnancy Outcomes

Study identification

• EU PAS number:
  EUPAS1000000927
• Study ID:
  1000000927
• Official title and acronym:
  Isotretinoin, Contraception, and Pregnancy Outcomes
• DARWIN EU® study:
  No
• Study countries:
  Canada
• Study description:
  Isotretinoin is commonly used in the treatment of severe acne. However, it is known to cause birth defects. To minimize this risk, the pregnancy prevention program in Canada requires the simultaneous use of two methods of contraception during isotretinoin therapy, among other safeguards. Findings from our previous study suggest suboptimal adherence to, or implementation of, the pregnancy prevention program. The main objective is to update our previous study to examine the frequency and change in frequency over time of contraception use, pregnancy occurrence, and pregnancy outcomes in individuals of childbearing age prescribed isotretinoin from 1997 to present. We will conduct a retrospective cohort study using administrative health care data from 5 Canadian provinces. We will identify female patients aged between 12 and 48 years old, inclusive, who initiated treatment with isotretinoin between 1997 and 2023. Patient and prescriber characteristics at treatment initiation will be described. We will estimate the utilization of contraception before, during, and after isotretinoin therapy. Pregnancy occurrence during and shortly after isotretinoin therapy will be estimated. We will examine trends over time to assess changes in contraception use and pregnancy incidence annually. Among pregnancies exposed to isotretinoin, we will identify the occurrence of pregnancy outcomes (live birth, spontaneous abortion, induced abortion, stillbirth, and termination for fetal anomaly). Rates of congenital malformations among live births following isotretinoin exposure will also be estimated.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Lady Davis Institute

University of British Columbia

University of Calgary, Calgary, Canada
University of Manitoba, Winnipeg, Canada
ICES, Toronto, Canada
Saskatchewan Health Quality Council, Saskatoon, Canada

Networks

Canadian Network for Observational Drug Effect Studies (CNODES)

Study timelines

Date when funding contract was signed

Actual:23/10/2025

Study start date

Actual:23/10/2025

Date of final study report

Planned:23/03/2027

Sources of funding

Other

More details on funding

CNODES is a collaborating core network partner of CoLab, which is funded for query-related activity by Canada’s Drug Agency (CDA, grant number C222 360).

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable