(213) Use of Isotretinoin Among Girls and Women of Childbearing Age and Exposure During Pregnancy

Publication Number: 544

Background: Given that isotretinoin is a potent human teratogen exposure during pregnancy must be avoided. Real-world data on use of isotretinoin in women of childbearing age are scarce.

Objectives: We aimed to assess trends in isotretinoin use among women of childbearing age in Germany, characterize users and estimate the number of pregnancies occurring under treatment with isotretinoin.

Methods: Using the German Pharmacoepidemiological Research Database (GePaRD, claims data from ~20% of the German population) we conducted cross-sectional analyses among girls/ women aged 13-49 years to determine age-specific and age-standardized prevalence of use of isotretinoin for each year between 2004 and 2016 (nominator: women with ≥1 dispensation of isotretinoin in the respective year; denominator: mid-year population). We characterized users regarding age and the specialty of the prescribing physician. Furthermore, we conducted a cohort analysis to determine the number of pregnancies between 2004 and 2016 occurring during isotretinoin therapy. For that purpose, we assigned an exposure window to each dispensation (date of dispensation + number of dispensed defined daily doses) and assessed whether it overlapped with the onset of pregnancy. The study was financed by Federal Institute for Drugs and Medical Devices (BfArM).

Results: We identified 39,627 girls/women with at least one dispensation of isotretinoin. Age-standardized prevalence of girls/women with ≥1 dispensation of isotretinoin per 1000 persons increased from 1.19 in 2004 to 1.87 in 2016 (57% increase). About 60% of isotretinoin users were in age group 16–30 years. In total, there were 249,624 dispensations of isotretinoin during the study period. Of these, 88.7% were prescribed by dermatologists and 5.9% by general practitioners. Overall, we identified 45 pregnancies exposed to isotretinoin at the onset of pregnancy. The number doubled when the month before pregnancy was also considered as relevant exposure.

Conclusions: Use of isotretinoin among women of childbearing age has increased in Germany between 2004 and 2016. The majority of users were in age groups with a high prevalence of child birth. Despite known teratogenic effects and pregnancy prevention programs, there are still pregnancies exposed to isotretinoin in Germany.