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

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.