Occurrence of pregnancy and pregnancy outcomes during isotretinoin therapy

David Henry, Colin Dormuth, Brandace Winquist, Greg Carney, Shawn Bugden, Gary F. Teare, Linda E. Lévesque, Anick Bérard, J. Michael Paterson, Robert W. Platt

Research output: Contribution to journalArticleResearchpeer-review

15 Citations (Scopus)

Abstract

Background: Isotretinoin, a teratogen, is widely used to treat cystic acne. Although the risks of pregnancy during isotretinoin therapy are well recognized, there are doubts about the level of adherence with the pregnancy prevention program in Canada. Our objective was to evaluate the effectiveness of the Canadian pregnancy prevention program in 4 provinces: British Columbia, Saskatchewan, Manitoba and Ontario. Methods: Using administrative data, we identified 4 historical cohorts of female users of isotretinoin (aged 12-48 yr) for the period 1996 to 2011. We defined pregnancy using International Statistical Classification of Diseases and billing codes. One definition included only cases with documented pregnancy outcomes (highspecificity definition); the other definition also included individuals recorded as receiving prenatal care (high-sensitivity definition). We studied new courses of isotretinoin and detected pregnancies in 2 time windows: during isotretinoin treatment only and up to 42 weeks after treatment. Live births were followed for 1 year to identify congenital malformations. Results: A total of 59 271 female patients received 102 308 courses of isotretinoin. Between 24.3% and 32.9% of participants received prescriptions for oral contraceptives while they were taking isotretinoin, compared with 28.3% to 35.9% in the 12 months before isotretinoin was started. According to the high-specificity definition of pregnancy, there were 186 pregnancies during isotretinoin treatment (3.1/1000 isotretinoin users), compared with 367 (6.2/1000 users) according to the high-sensitivity definition. By 42 weeks after treatment, there were 1473 pregnancies (24.9/1000 users), according to the highspecificity definition. Of these, 1331 (90.4%) terminated spontaneously or were terminated by medical intervention. Among the 118 live births were 11 (9.3%) cases of congenital malformation. Pregnancy rates during isotretinoin treatment remained constant between 1996 and 2011. Interpretation: Adherence to the isotretinoin pregnancy prevention program in Canada was poor during the 15-year period of this study.

Original languageEnglish
Pages (from-to)723-730
Number of pages8
JournalCMAJ
Volume188
Issue number10
DOIs
Publication statusPublished - 12 Jul 2016
Externally publishedYes

Fingerprint

Isotretinoin
Pregnancy Outcome
Pregnancy
Therapeutics
Live Birth
Canada
Saskatchewan
Manitoba
Teratogens
British Columbia
Prenatal Care
Acne Vulgaris
International Classification of Diseases
Ontario
Pregnancy Rate
Oral Contraceptives
Prescriptions

Cite this

Henry, D., Dormuth, C., Winquist, B., Carney, G., Bugden, S., Teare, G. F., ... Platt, R. W. (2016). Occurrence of pregnancy and pregnancy outcomes during isotretinoin therapy. CMAJ, 188(10), 723-730. https://doi.org/10.1503/cmaj.151243
Henry, David ; Dormuth, Colin ; Winquist, Brandace ; Carney, Greg ; Bugden, Shawn ; Teare, Gary F. ; Lévesque, Linda E. ; Bérard, Anick ; Paterson, J. Michael ; Platt, Robert W. / Occurrence of pregnancy and pregnancy outcomes during isotretinoin therapy. In: CMAJ. 2016 ; Vol. 188, No. 10. pp. 723-730.
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abstract = "Background: Isotretinoin, a teratogen, is widely used to treat cystic acne. Although the risks of pregnancy during isotretinoin therapy are well recognized, there are doubts about the level of adherence with the pregnancy prevention program in Canada. Our objective was to evaluate the effectiveness of the Canadian pregnancy prevention program in 4 provinces: British Columbia, Saskatchewan, Manitoba and Ontario. Methods: Using administrative data, we identified 4 historical cohorts of female users of isotretinoin (aged 12-48 yr) for the period 1996 to 2011. We defined pregnancy using International Statistical Classification of Diseases and billing codes. One definition included only cases with documented pregnancy outcomes (highspecificity definition); the other definition also included individuals recorded as receiving prenatal care (high-sensitivity definition). We studied new courses of isotretinoin and detected pregnancies in 2 time windows: during isotretinoin treatment only and up to 42 weeks after treatment. Live births were followed for 1 year to identify congenital malformations. Results: A total of 59 271 female patients received 102 308 courses of isotretinoin. Between 24.3{\%} and 32.9{\%} of participants received prescriptions for oral contraceptives while they were taking isotretinoin, compared with 28.3{\%} to 35.9{\%} in the 12 months before isotretinoin was started. According to the high-specificity definition of pregnancy, there were 186 pregnancies during isotretinoin treatment (3.1/1000 isotretinoin users), compared with 367 (6.2/1000 users) according to the high-sensitivity definition. By 42 weeks after treatment, there were 1473 pregnancies (24.9/1000 users), according to the highspecificity definition. Of these, 1331 (90.4{\%}) terminated spontaneously or were terminated by medical intervention. Among the 118 live births were 11 (9.3{\%}) cases of congenital malformation. Pregnancy rates during isotretinoin treatment remained constant between 1996 and 2011. Interpretation: Adherence to the isotretinoin pregnancy prevention program in Canada was poor during the 15-year period of this study.",
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Henry, D, Dormuth, C, Winquist, B, Carney, G, Bugden, S, Teare, GF, Lévesque, LE, Bérard, A, Paterson, JM & Platt, RW 2016, 'Occurrence of pregnancy and pregnancy outcomes during isotretinoin therapy' CMAJ, vol. 188, no. 10, pp. 723-730. https://doi.org/10.1503/cmaj.151243

Occurrence of pregnancy and pregnancy outcomes during isotretinoin therapy. / Henry, David; Dormuth, Colin; Winquist, Brandace; Carney, Greg; Bugden, Shawn; Teare, Gary F.; Lévesque, Linda E.; Bérard, Anick; Paterson, J. Michael; Platt, Robert W.

In: CMAJ, Vol. 188, No. 10, 12.07.2016, p. 723-730.

Research output: Contribution to journalArticleResearchpeer-review

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AU - Henry, David

AU - Dormuth, Colin

AU - Winquist, Brandace

AU - Carney, Greg

AU - Bugden, Shawn

AU - Teare, Gary F.

AU - Lévesque, Linda E.

AU - Bérard, Anick

AU - Paterson, J. Michael

AU - Platt, Robert W.

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Henry D, Dormuth C, Winquist B, Carney G, Bugden S, Teare GF et al. Occurrence of pregnancy and pregnancy outcomes during isotretinoin therapy. CMAJ. 2016 Jul 12;188(10):723-730. https://doi.org/10.1503/cmaj.151243