Assessment of Infant Exposure to Antidepressants through Breastfeeding: A Literature Review of Currently Available Approaches.

Despite the prevalence of depression in lactating mothers, there is a lack of knowledge about the excretion of antidepressants into breast milk and its potential adverse effects on infants. This creates concern, making depressed lactating mothers more likely to avoid pharmacological treatment. Clinical lactation studies are the most accurate and direct method to predict and demonstrate the excretion of antidepressants into human breast milk, and results from clinical studies can be included in drug labels to help physicians and patients make decisions on antidepressant use during lactation. However, there are limited clinical trials and studies on the pharmacokinetics of antidepressants in lactating women because of a lack of enrollment and ethical and confounding factors, creating a lack of knowledge in this area. To bridge this gap in knowledge, alternative methods should be sought to help estimate the antidepressant concentration in breast milk, which is used to assess the safety and transfer of antidepressants into breast milk. We provide a comprehensive review of the usage of these cost-effective, time-efficient, and ethically feasible methods that serve to provide a valuable estimation of the safety and transfer of antidepressants into breast milk before conducting clinical studies.

B cell-targeted therapies in systemic lupus erythematosus.

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease of unknown etiology that primarily affects women of childbearing age. There is no disease more heterogeneous than SLE as patients experience a myriad of manifestations and unpredictable periods of heightened disease activity. This heterogeneity not only makes it difficult for treatment decisions and prognostication, but has made drug development quite challenging. Despite these challenges, belimumab, voclosporin, and anifromulab, approved by the United States Food and Drug Administration (FDA) to treat SLE or lupus nephritis (LN), enhanced our armamentarium of traditional therapies, such as hydroxychloroquine, corticosteroids, and immunosuppressives. However, there remains a dire need to develop therapies that offer greater efficacy and safety. Patients with SLE produce excessive amounts of autoantibodies and cytokines that result in inflammation and organ damage. While a considerable number of potential drug development targets exist, there has been much attention focused on B cells. Strategies have included direct B cell killing, modulation of B cell function, inhibition of molecules essential to B cell growth and survival, and acceleration of autoantibody clearance, to name just a few. In this article, we review SLE clinical trials evaluating experimental agents that target B cells or plasma cells.