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Eur J Clin Pharmacol 2021 Jun 8. Epub 2021 Jun 8.

Teratology Information, Department of Emergency Medicine Services, Helsinki University and Helsinki University Hospital, Tukholmankatu 17, 00029 HUS, Helsinki, Finland.

Purpose: To study if second-generation antipsychotic (S-GA) use during the first trimester of pregnancy is associated with an increased risk of major congenital malformations (MCM).

Methods: A population-based birth cohort study using national register data extracted from the Drugs and Pregnancy database in Finland, years 1996-2017. The sampling frame included 1,273,987 pregnant women. Read More

Expert Opin Drug Saf 2021 Jun 8:1-8. Epub 2021 Jun 8.

Epidemiology & Benefit-Risk, Global Pharmacovigilance, Sanofi, Chilly-Mazarin, France.

: Inconsistencies in information on safety of medicine use during pregnancy and lactation can result in sub-optimal treatment for pregnant and lactating women, risks to the fetus or child and unnecessary weaning off breastfeeding. The objective of this study was to analyze information discrepancies regarding medicine use during pregnancy and lactation between on-line sources for patients and health care professionals (HCPs) in four European languages.: The medicines analyzed were ibuprofen, ondansetron, olanzapine, fingolimod, methylphenidate and adalimumab. Read More

Clin Toxicol (Phila) 2021 May 28:1-9. Epub 2021 May 28.

Toxicology Unit and Poison Control Centre, Teratology Information Service, Careggi University Hospital, Florence, Italy.

Introduction: Exposure of the embryo or fetus to ionizing radiations is a potential danger since it may induce clinically relevant fetal and/or neonatal damages. The aim of the present study was to examine fetal and neonatal outcomes after maternal exposure to radio-diagnostic procedures during first trimester of pregnancy, and to evaluate whether these effects might be related to the fetal absorbed dose of ionizing radiations.

Methods: A 10-year prospective cohort study was performed on 1979 pregnant women who underwent a radio-diagnostic procedure within the first trimester of pregnancy. Read More

Front Genet 2021 27;12:645555. Epub 2021 Apr 27.

Pharmacoepidemiology and Drug Safety Research Group, Department of Pharmacy, Faculty of Mathematics and Natural Sciences, University of Oslo, Oslo, Norway.

Since the 1960s, drugs have been known to cause teratogenic effects in humans. Such teratogenicity has been postulated to be influenced by genetics. The aim of this review was to provide an overview of the current knowledge on genetic susceptibility to drug teratogenicity in humans and reflect on future directions within the field of genetic teratology. Read More

Int J Environ Res Public Health 2021 03 24;18(7). Epub 2021 Mar 24.

Pharmacoepidemiology and Drug Safety Research Group, Department of Pharmacy, and PharmaTox Strategic Initiative, Faculty of Mathematics and Natural Sciences, University of Oslo, 0316 Oslo, Norway.

The COVID-19 pandemic may be of particular concern for pregnant and breastfeeding women. We aimed to explore their beliefs about the coronavirus and COVID-19 vaccine willingness and to assess the impact of the pandemic on perinatal experiences and practices. A multinational, cross-sectional, web-based study was performed in six European countries between April and July 2020. Read More

Med J Aust 2021 04 24;214(6):286-286.e1. Epub 2021 Feb 24.

Melbourne, VIC.

Acta Obstet Gynecol Scand 2021 Jan 21. Epub 2021 Jan 21.

Pharmacoepidemiology and Drug Safety Research Group, Department of Pharmacy, PharmaTox Strategic Initiative, Faculty of Mathematics and Natural Sciences, University of Oslo, Oslo, Norway.

Introduction: Evidence on perinatal mental health during the coronavirus disease 2019 (COVID-19) pandemic and its potential determinants is limited. Therefore, this multinational study aimed to assess the mental health status of pregnant and breastfeeding women during the pandemic, and to explore potential associations between depressive symptoms, anxiety, and stress and women's sociodemographic, health, and reproductive characteristics.

Material And Methods: A cross-sectional, web-based study was performed in Ireland, Norway, Switzerland, the Netherlands, and the UK between 16 June and 14 July 2020. Read More

Neurotoxicol Teratol 2021 Jan-Feb;83:106946. Epub 2020 Dec 23.

Department of Pediatrics, Case Western Reserve University, United States.

Prenatal alcohol exposure (PAE) continues to be a serious public health problem, yet no reliable clinical tools are available for assessing levels of drinking during pregnancy. Fatty acid ethyl esters (FAEEs), the nonoxidative metabolites of ethanol measured in meconium, are potential biomarkers to quantify the level of PAE. The association between the concentrations of FAEEs from meconium and adolescent substance use and related problems was examined in a prospective birth-cohort of adolescents exposed to alcohol and drugs in utero. Read More

BMC Pediatr 2020 11 30;20(1):539. Epub 2020 Nov 30.

Division of Psychiatry, University of Western Australia, Crawley, Western Australia, 6009, Australia.

Background: Cardiovascular anomalies are the largest group of congenital anomalies and the major cause of death in young children, with various data linking rising atrial septal defect incidence (ASDI) with prenatal cannabis exposure. Objectives / Hypotheses. Is cannabis associated with ASDI in USA? Is this relationship causal?

Methods: Geospatiotemporal cohort study, 1991-2016. Read More

Lancet Haematol 2020 Dec;7(12):e884-e891

Department of Medicine I, Division of Haematology and Haemostaseology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.

Background: Direct oral anticoagulants (DOACs) have largely replaced vitamin K antagonists in many indications for anticoagulation. Prescribed to millions of patients, including women of reproductive age, exposure to DOACs in early pregnancy is not uncommon, but data on the embryotoxic risks are scarce. We aimed to assess the risk of DOAC embryotoxicity in a large sample of reported cases. Read More

Open Forum Infect Dis 2020 Nov 10;7(11):ofaa479. Epub 2020 Oct 10.

The Israeli Teratology Information Service, Israel Ministry of Health, Jerusalem, Israel.

We report the pregnancy outcomes of 6 women with cutaneous leishmaniasis; 5 of these women received topical antileishmenial therapy during gestation with paromomycin plus methylbenzethonium chloride combination ointment and/or sodium stibogluconate intralesional injections. No teratogenic effects were reported. Furthermore, no vertical transmission was observed. Read More

Clin Toxicol (Phila) 2021 Jun 23;59(6):457-463. Epub 2020 Oct 23.

Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.

Introduction: During pregnancy and breastfeeding, many women require prescription medications. Concerns about drug effects on the fetus or breastfed infant may lead to decreased adherence. Our objective was to evaluate the adherence of pregnant and breastfeeding Israeli women to prescription drugs, the information they received regarding drug safety, and the women's awareness and pattern of the use of Teratogen Information Services (TIS) in Israel. Read More

Neurotoxicol Teratol 2020 Nov - Dec;82:106930. Epub 2020 Oct 18.

Center for Behavioral Teratology, Dept. of Psychology, San Diego State University, USA. Electronic address:

Cannabis is the most frequently used illicit drug among pregnant women, yet the potential consequences of prenatal cannabis exposure on development are not well understood. Electronic cigarettes have become an increasingly popular route of administration among pregnant women, in part to user's perception that e-cigarettes are a safer route for consuming cannabis products. Importantly, half of pregnant women who consume cannabis also report consuming alcohol, but research investigating co-consumption of these drugs is limited, particularly with current routes of administration. Read More

J Perinat Med 2020 Nov;48(9):1001-1007

Bergamo Teratology Information Service, Papa Giovanni XXIII Hospital, 24100 BergamoItaly.

Objectives The severe acute respiratory syndrome coronavirus 2 (COVID-19) outbreak in Italy, especially in Lombardy and Bergamo city, represented probably nowadays one of the first major clusters of COVID-19 in the world. The aim of this report is to describe the activity of Bergamo Teratology Information Service (TIS) in supporting the public and health-care personnel in case of drug prescriptions in suspected/confirmed COVID-19 pregnant and lactating patients during COVID-19 outbreak in Italy. Methods All Bergamo TIS requests concerning COVID-19 pregnant and lactating women have been retrospectively evaluated from 1 March to 15 April 2020. Read More

BJOG 2021 01 29;128(1):111-112. Epub 2020 Sep 29.

The UK Teratology Information Service, Newcastle upon Tyne, UK.

Expert Rev Clin Pharmacol 2020 Sep 3;13(9):991-1000. Epub 2020 Oct 3.

Teratology Information Center, Terafar-Izmir Katip Celebi University , Izmir, Turkey.

Introduction: The medications used in assisted reproduction are given before and during early pregnancy, and hence, they may potentially result in adverse fetal effects. In this review we present an updated account of their fetal safety and discuss methodological challenges in interpretation of existing data.

Areas Covered: The fetal safety/risks of clomiphene citrate, aromatase inhibitors, metformin, gonadotropins and progestins are discussed. Read More

Birth Defects Res 2020 11 7;112(18):1505-1512. Epub 2020 Aug 7.

Epidemiology, Value Evidence Outcomes, GlaxoSmithKline, Uxbridge UK, Research Triangle Park, North Carolina, USA.

Background: Integration of animal and human data to assess potential risks of the use of medications in pregnancy is important. A qualitative weight of evidence process enables all available evidence to be considered in a consistent, systematic manner.

Methods: We aim to describe the weight of evidence methodology utilized by the authors, a summary of which was presented at the 59th Annual Meeting of the Teratology Society entitled "Integration of Human and Animal Data to Inform Medication Use in Pregnant Women. Read More

Mult Scler Relat Disord 2020 Aug 6;43:102146. Epub 2020 May 6.

University of Cambridge, Cambridge, United Kingdom. Electronic address:

Background: Relapsing-remitting multiple sclerosis (RRMS) is frequently diagnosed in women of reproductive age. Because the use of disease-modifying therapies (DMTs) early in the disease course is increasing, it is important to evaluate the safety of DMTs in pregnant women and their developing fetuses. Alemtuzumab, approved for the treatment of relapsing forms of MS, is administered as 2 courses of 12 mg/day on 5 consecutive days at baseline and on 3 consecutive days 12 months later. Read More

Br J Clin Pharmacol 2020 12 26;86(12):2377-2392. Epub 2020 May 26.

PHARMO Institute for Drug Outcomes Research, Utrecht, The Netherlands.

Aims: Recent population-based data on drug utilization around pregnancy are lacking. This study aims to examine the prevalence of drug exposure in the Netherlands during the preconception, pregnancy and postpartum periods, with special emphasis on trends of potentially harmful medication over the years.

Methods: A population-based study was conducted using records from the PHARMO Perinatal Research Network. Read More

Matern Child Health J 2020 Jul;24(7):901-910

National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, 4770 Buford Highway NE, Atlanta, GA, 30341-3717, USA.

Introduction: Women and healthcare providers lack adequate information on medication safety during pregnancy. While resources describing fetal risk are available, information is provided in multiple locations, often with subjective assessments of available data. We developed a list of medications of greatest concern during pregnancy to help healthcare providers counsel reproductive-aged and pregnant women. Read More

Matern Child Health J 2020 May;24(5):531-536

Regional Medicines Information and Pharmacovigilance Centre (RELIS Vest), Department of Medical Biochemistry and Pharmacology, Haukeland University Hospital, 5021, Bergen, Norway.

Purpose: Approximately 80% of pregnant women use medications. There is a need for evidence based medicines information that provide realistic risk estimates as pregnant and breastfeeding women tend to overestimate the risk of medications. The purpose of this paper is to describe the development and future perspectives of an innovative medicines information service aiming to increase empowerment among pregnant and breastfeeding women. Read More

Int J Mol Sci 2020 Mar 13;21(6). Epub 2020 Mar 13.

Departments of Molecular Biology and Nutrition Sciences, Ariel University, Ariel 40700, Israel.

Exposure to certain environmental factors during the early stages of development was found to affect health in adulthood. Among other environmental factors, oxidative stress has been suggested to be involved in fetal programming, leading to elevated risk for metabolic disorders, including type 2 diabetes; however, the possibility that antioxidant consumption during early life may affect the development of diabetes has scarcely been studied. The aim of this study was to investigate the effects of -acetyl-l-cysteine (NAC) given during pregnancy and lactation on the susceptibility of offspring to develop glucose intolerance at adulthood. Read More

Eur J Obstet Gynecol Reprod Biol 2020 Apr 30;247:42-48. Epub 2020 Jan 30.

Division of Clinical Pharmacology & Toxicology, Department of Anaesthesiology, Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals & University of Geneva, Geneva, Switzerland. Electronic address:

Objective: We aimed to characterize drug exposures during pregnancy where the outcome was known that had benefited from counselling through our Teratology Information Service (TIS) between 1994-2016.

Study Design: This observational study analysed data collected through the drug exposures during pregnancy counselling. Data was analysed descriptively. Read More

Drug Alcohol Rev 2020 03 26;39(3):223-231. Epub 2020 Jan 26.

Centre for Big Data Research in Health, UNSW Sydney, Sydney, Australia.

Introduction And Aims: Few smokers use smoking cessation pharmacotherapies during pregnancy. It is hypothesised that health-care providers' reluctance due to safety concerns contributes to their low use. This study examined the extent of providers' concern regarding smoking cessation pharmacotherapies, relative to other medications in the same and other pregnancy risk categories. Read More

Dermatol Ther 2020 01 27;33(1):e13192. Epub 2019 Dec 27.

Department of Pharmacology, Teratology Information Service, Faculty of Medicine, Kahramanmaras Sütçü Imam University, Kahramanmaras, Turkey.

Isotretinoin is known as a potent teratogenic agent. Pregnancy should be ruled out before isotretinoin is prescribed. In this study, we evaluated the fetal outcomes of pregnant women who had inadvertently been exposed to isotretinoin during or before pregnancy. Read More

Br J Clin Pharmacol 2020 05 20;86(5):868-879. Epub 2020 Jan 20.

Teratology Information, Department of Emergency Medicine Services, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.

Aims: P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) are efflux transporters expressed in the placenta, limiting their substrates from reaching the foetus. Our aim was to investigate if concomitant prenatal exposure to several substrates or inhibitors of these transporters increases the risk of congenital anomalies.

Methods: The national Drugs and Pregnancy database, years 1996-2014, was utilized in this population-based birth cohort study. Read More

J Alzheimers Dis 2020 ;73(2):517-528

Department of Human Anatomy and Key Laboratory of Experimental Teratology, Ministry of Education, Shandong University School of Medicine, Jinan, Shandong, China.

The cell surface level of apolipoprotein E receptor 2 (ApoER2) increases by cyclic transport of ApoER2 and then activates Reelin signaling pathway to exert neuroprotective function in AD. ApoER2 ligand Apolipoprotein E4 (ApoE4) inhibits the recycling of ApoER2 to the cell surface rendering neurons unresponsive to Reelin. Carnosic acid (CA) is proven to possess neuroprotective and neurotrophic functions in Alzheimer's disease (AD) mouse model. Read More

Hum Exp Toxicol 2020 Apr 1;39(4):411-422. Epub 2019 Dec 1.

Institute of Environmental, Chemical and Pharmaceutical Sciences, Federal University of São Paulo (ICAQF-UNIFESP), Diadema, SP, Brazil.

This study aimed to evaluate maternal toxicity, teratogenic, and placental oxidative effects resulting from the exposure of rats to crack cocaine smoke during pregnancy. Pregnant rats were exposed either to the smoke of crack and ashes (Crack) or to the smoke of ashes alone, nonexposed or pair-fed with the Crack group. Crack group was exposed to the smoke resulting from the burning of 250 mg of crack for 10 min, twice a day, from 7 days prior to mating until cesarian on gestational day 20. Read More

Stat Med 2020 02 1;39(4):481-493. Epub 2019 Dec 1.

Institute of Statistics, Ulm University, Ulm, Germany.

Both delayed study entry (left-truncation) and competing risks are common phenomena in observational time-to-event studies. For example, in studies conducted by Teratology Information Services (TIS) on adverse drug reactions during pregnancy, the natural time scale is gestational age, but women enter the study after time origin and upon contact with the service. Competing risks are present, because an elective termination may be precluded by a spontaneous abortion. Read More

Eur J Clin Pharmacol 2020 Jan 3;76(1):107-115. Epub 2019 Nov 3.

Teratology Information, Department of Emergency Medicine Services, Helsinki University and Helsinki University Hospital, Tukholmankatu 17, 00029, Helsinki, Finland.

Purpose: To study if second-generation antipsychotic (S-GA) use during pregnancy is associated with an increased risk of pregnancy and neonatal complications.

Methods: A population-based birth cohort study using national register data extracted from the "Drugs and Pregnancy" database in Finland, years 1996-2016. The sampling frame included 1,181,090 pregnant women and their singleton births. Read More