Mirtazapine in pregnancy and lactation: A systematic review of adverse outcomes.

Introduction: Peripartum depression is common and treatment with mirtazapine may be indicated. However, evidence on its safety in pregnancy and lactation is fragmented. The objective of this systematic review was to evaluate the literature on the safety of mirtazapine in pregnancy and lactation.

Adverse drug reactions in neonates: a brief analysis of the FDA adverse event reporting system.

Introduction: Drug trials in neonates are scarce, and the neonates may consequently be at risk of adverse drug reactions (ADRs). Spontaneous ADR reporting is an important tool for expanding the knowledge on drug safety in neonates. This study explores the quality of current neonatal ADR reports and the ADR reports of the most common drugs used in neonatal departments.

Healthcare professionals' experiences with the use of antipsychotics in dementia.

Background: Antipsychotics are commonly administered to nursing home residents with dementia, despite the associated risk of severe adverse events.

Objective: This study aimed to explore healthcare professionals' experiences in caring for nursing home residents with dementia, with a focus on rationales behind the use of antipsychotics.

Method: Twelve semi-structured interviews with healthcare professionals' from Danish nursing homes were conducted and analyzed using the method Systematic Text Condensation.

Excessive androgen exposure and risk of malignancies: A cohort study.

Background: A link between androgen use and the risk of cancers, especially prostate and breast cancer, has been suggested. The knowledge about a possible association is limited.

Objective: The study aimed to investigate cancer incidence rates, particularly those related to prostate and breast cancer, in male androgen users and compare them to a control group.

Extensive androgen exposure and meningioma risk - A matched cohort study.

Introduction: Meningiomas frequently occur within the field of neuro-oncology, but it is unclear whether exogenous or imbalanced endogenous hormones are involved in the pathophysiology. A previous case-control study found an almost 20-fold increase in the risk of developing meningioma among users of androgenic anabolic steroids. We, therefore, investigated this hypothesis.

Protocol for DEprescribing and Care to reduce Antipsychotics in Dementia (DECADE)-A hybrid effectiveness-implementation pilot study.

Introduction: Behavioural and psychological symptoms of dementia (BPSD) should only rarely and briefly be treated with antipsychotics. Despite recommendations to the contrary, the use of antipsychotics in nursing home residents with dementia is widespread and followed by serious adverse effects. Intervention studies on methods to reduce the use of antipsychotics in persons with dementia are few and needed.

Interferon-beta exposure in-utero and the risk of infections in early childhood.

Background: Knowledge within the field of multiple sclerosis treatment during pregnancy is vital to ensure the most optimal clinical practice. Immunomodulatory treatment in pregnancy could in theory affect the normal development and maturation of the immune system of the fetus with a potential increased risk of infections, consequently. We therefore set out to investigate whether exposure to interferon-beta in utero affected the risk of acquiring infections in early childhood.

Duloxetine Exposure During Pregnancy and the Risk of Offspring Being Born Small for Gestational Age or Prematurely: A Nationwide Danish and Swedish Safety Study.

Background: Depression or depressive symptoms are common among pregnant women. The use of antidepressants during pregnancy has grown steadily. The risk of offspring being born small for gestational age or prematurely when exposed to duloxetine during pregnancy is not established.

Psychiatric morbidity among men using anabolic steroids.

Objective: The purpose of this study was to investigate the psychiatric morbidity among men with abuse of anabolic steroids.

Methods: The design is a retrospectively matched cohort study. Five hundred and fourty-five males, who tested positive for anabolic steroids in Danish fitness centers during the period January 3, 2006 to March 1, 2018, were matched with 5450 randomly chosen male controls.

Short-term mortality following tramadol poisonings in Denmark.

Tramadol is a commonly used opioid with a potential of addiction and abuse. Using Danish nationwide registers, we aimed to (1) characterise opioid poisonings; (2) assess the 30-day mortality following morphine, oxycodone, and mixed poisonings compared to tramadol poisonings; and (3) assess the development in tramadol poisonings during a 12-year period. Poisonings were identified from 2006 to 2017.

Mirtazapine exposure in pregnancy and fetal safety: A nationwide cohort study.

Objective: To investigate the association between mirtazapine exposure in pregnancy and risk of specific adverse pregnancy outcomes.

Methods: A register-based nationwide cohort study was conducted including all registered pregnancies in Denmark from 1997 to 2016. Mirtazapine-exposed pregnancies were compared with mirtazapine unexposed pregnancies in a 1:4 ratio matched according to propensity scores.

Exposure to Tramadol During Early Pregnancy and Risk of Spontaneous Abortion or Major Congenital Malformations.

Objective: To investigate whether exposure to tramadol during early pregnancy is associated with an increased risk of spontaneous abortion or major congenital malformations.

Methods: The study is a nationwide cohort study including all registered pregnancies in Denmark between January 1, 1997, and December 31, 2016. The Danish National Prescription Register was used to identify maternal exposure to tramadol.

The Blind Spot of Pharmacology: A Scoping Review of Drug Metabolism in Prematurely Born Children.

The limit for possible survival after extremely preterm birth has steadily improved and consequently, more premature neonates with increasingly lower gestational age at birth now require care. This specialized care often include intensive pharmacological treatment, yet there is currently insufficient knowledge of gestational age dependent differences in drug metabolism. This potentially puts the preterm neonates at risk of receiving sub-optimal drug doses with a subsequent increased risk of adverse or insufficient drug effects, and often pediatricians are forced to prescribe medication as off-label or even off-science.

Ciprofloxacin exposure and adverse pregnancy outcomes: A Danish nationwide cohort study.

Objective: To examine the association between maternal exposure to ciprofloxacin and the risk of miscarriage and major malformations.

Design: A nationwide register-based cohort study.

Setting: Data were obtained from the Medical Birth Registry, the National Hospital Registry, the Danish National Prescription Registry and Statistics Denmark.

Exposure to duloxetine during pregnancy and risk of congenital malformations and stillbirth: A nationwide cohort study in Denmark and Sweden.

Background: The prevalence of depression and the exposure to antidepressants are high among women of reproductive age and during pregnancy. Duloxetine is a selective serotonin-norepinephrine reuptake inhibitor (SNRI) approved in the United States and Europe in 2004 for the treatment of depression. Fetal safety of duloxetine is not well established.

Therapeutic concentration of ciprofloxacin and transfer across the human term placenta.

Background: Pregnant women have an increased risk of infections, and early and decisive treatment is preferred to prevent complications. Although ciprofloxacin is very commonly used, safety aspects of maternal treatment during pregnancy are limited, and avoidance of its use during late pregnancy is recommended.

Objective: The aim is to estimate maternal-to-fetal transfer clearance of ciprofloxacin at a therapeutic concentration and to determine fetal exposure to maternally administered ciprofloxacin.

Duloxetine Exposure During Pregnancy and the Risk of Spontaneous and Elective Abortion: A Danish Nationwide Observational Study.

Background: Depression and antidepressant treatment are widespread among women of childbearing age.

Objective: This study evaluates the association between duloxetine exposure during pregnancy and spontaneous and elective abortions.

Patients And Methods: The nationwide, observational study based on register data from Denmark included women with a recorded pregnancy in the birth register or an abortion in the patient register between 2004 and 2016.

Evaluation of Topical Corticosteroid Use in Pregnancy and Risk of Newborns Being Small for Gestational Age and Having Low Birth Weight.

Importance: Topical corticosteroids are frequently used during pregnancy. Limited data have raised concerns about an increased risk of the newborn being small for gestational age (SGA) and having low birth weight, in particular with use of potent to very potent agents during pregnancy.

Objective: To evaluate whether topical corticosteroid use in pregnancy is associated with increased risks of SGA and low birth weight.

Association between use of macrolides in pregnancy and risk of major birth defects: nationwide, register based cohort study.

Objective: To examine the association between the use of macrolide antibiotics in pregnancy and the risk of major birth defects.

Design: Nationwide, register based cohort study.

Setting: Denmark, 1997-2016.