Real-World Fetal Exposure to Acne Treatments in the United States: A Retrospective Analysis from 2006 to 2015

Abstract

Introduction: Several studies have evaluated the effects of changes in isotretinoin risk mitigation programs, but little is known about actual fetal exposure rates in the context of other acne treatments. Objective: Our objective was to quantify fetal exposure rates during the use of common acne treatments. Methods: Employing the insurance claims data of > 100,000 acne treatment users between 2006 and 2015, we created three user cohorts: (1) isotretinoin (strong teratogen/mandatory risk mitigation program), (2) doxycycline/minocycline (mild teratogen, label warning), and (3) topical clindamycin/erythromycin (no fetal risk). Fetal exposure rates overall and stratified by age were compared after adjusting for potential confounders. Results: Contraceptive use during acne treatment was < 50% in isotretinoin users and < 30% in the other study groups. Long-acting contraceptives contributed to 1% of all contraceptives used, with 90% being oral contraceptives. Isotretinoin users had 19.2 (95% confidence interval [CI] 20.3 to 17.9) fewer fetal exposures per 1000 person-years of use compared with doxycycline/minocycline users, which in turn had 28.8 (95% CI 31.2 to 26.3) fewer pregnancies compared with clindamycin/erythromycin users. Stratification by age showed attenuated differences in fetal exposure among acne treatment groups for teenagers. Conclusion: Fetal exposure to acne treatments varied according to levels of teratogenicity, with reduced rates among users of isotretinoin and to a lesser extent doxycycline/minocycline. Teenagers had low pregnancy rates but less pronounced differences in fetal exposure across acne treatments.