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.

Prenatal Care Initiation and Exposure to Teratogenic Medications

“…5 Despite these strategies, isotretinoin-exposed pregnancies do occur. 6,7 For pregnancies in which efforts to prevent exposure to teratogenic medications have failed, early initiation of prenatal care is essential to allow discussion of the potential risks, pregnancy monitoring for teratogenic effects, and discussion of options including pregnancy termination. 8,9 For example, among 2720 pregnancies documented among more than 4 million patients who registered in the iPLEDGE program since its inception, 46% resulted in elective termination, 4.6% resulted in a live delivery, and 33.8% were lost to follow-up 10 ; these data contrast with the elective abortion rates reported for the general population in the US (<20%).…”

Emergency contraception in the iPLEDGE program: A cross‐sectional survey of pediatric dermatology provider understanding and practice

“…2 Abstinence is the chosen form of contraception in more than 50% of patients aged 15-19 years. 3 Emergency contraception (EC) becomes critical when abstinence fails or contraception is not used properly. Despite this, EC is only mentioned briefly as an attestation statement in the iPLEDGE Patient Information/Informed Consent About Birth Defects ("I have received information on emergency birth control") and otherwise not discussed at all in the other online iPLEDGE educational materials, including the iPLEDGE REMS Providers Guide and the iPLEDGE REMS Guide for Patients Who Can Get Pregnant.…”

“…The most common reasons for pregnancy included ineffective or inconsistent use of contraceptive agents and unsuccessful abstinence 2 . Abstinence is the chosen form of contraception in more than 50% of patients aged 15–19 years 3 . Emergency contraception (EC) becomes critical when abstinence fails or contraception is not used properly.…”