New changes in pregnancy and lactation labelling: Review of dermatologic drugs

Abstract

BackgroundThe U.S. Food and Drug Administration has published new pregnancy and lactation labelling rules that set standards on the presentation of information with regard to drug usage during pregnancy and breastfeeding, as well as the effects on fertility. These guidelines became effective June 30, 2015, and classified the risks of using prescription drugs during pregnancy in three detailed subsections: Pregnancy, Lactation, and Females and Males of Reproductive Potential. These sections describe the risks within a real-world context of caring for these patients.ObjectiveIn this study, we reclassified and categorized drugs and treatments commonly used in dermatology according to these new guidelines.MethodsWe performed a search of the medical literature about the use of relevant prescription drugs during pregnancy and breastfeeding and their effect on fertility. The search included prospective and retrospective studies, review articles from PubMed-indexed journals (from inception to November 2018), U.S. Food and Drug Administration records, pregnancy exposure registries, relevant information and studies provided in drug labeling by companies, and updated pharmacologic texts and guidelines up to 2018.ResultsTopical immunomodulators, systemic immunomodulators (including biologics), systemic antipruritic agents, antimicrobials, as well as acne, hair, and cosmetic agents were included. We have made best attempts to review and consolidate existing and new data and include them in our guide.ConclusionThis new narrative format facilitates prescribing by considering a variety of factors. One previously overlooked aspect was the impact on the reproductive potential of both male and female patients. Rather than depending on overly simplistic letter risk categories, dermatologists will now need to make prescribing decisions based on each patient and the information provided, which will allow for better decision making and patient care.

Low dose of isotretinoin: A comprehensive review

“…Safe implementation of iPLEDGE drawn attention of researchers who suggested reforming or redesign of iPLEDGE to reduce the number of pregnancies and fetal risk. Embryopathy has been reported even with single doses (Koh, Tian, & Oon, 2019). Follow-up for neuropsychological development delays, which may appear in later life, to be considered for live-born babies to isotretinoin-exposed mothers (Altıntaş Aykan & Ergün, 2019).…”

Practical compendium for psoriasis management

“…*Long history of use of topical CCS indicates their safety. It is better to keep the amount used for mild potent <100 g/week, for midpotent and potent <50 g/week and for super potent 30 g/week (Koh, Tian, & Oon, ; A. Nast et al, ; Rademaker et al, ). **Folic acid supplement is essential since UVB lowers folic acid levels and might cause neural tube defects in the fetus (Elmets, Lim et al, ).…”

“…*Long history of use of topical CCS indicates their safety. It is better to keep the amount used for mild potent <100 g/week, for midpotent and potent <50 g/week and for super potent 30 g/week (Koh, Tian, & Oon, 2019;A. Nast et al, 2018b;Rademaker et al, 2018).…”

“…Nast et al, 2018a). German guidelines consider pregnancy as a relative contraindication for all biologics, however secukinumab, an IL17 Lactation (Amatore et al, 2019;Koh et al, 2019;A. Nast et al, 2018b;Rademaker et al, 2018) Recommended If methotrexate is to be used in a lactating mother, the breast feeding should be stopped for 24 hr after the methotrexate dose.…”

Interaction of psoriasis and pregnancy: Maternal and fetal outcomes

“…In a cohort study using prospective data There are still some diffi culties in treatment due to the lack of well-established guidelines in pregnant women with psoriasis. However, United States and European drug labeling now summarize safety data on pregnancy and lactation to inform treatment choice in this patient population [8,48].…”