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Br J Clin Pharmacol 2020 May 6. Epub 2020 May 6.

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

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 May 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

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

Acta Neurol Belg 2019 Oct 28. Epub 2019 Oct 28.

Department of Pharmacology, Teratology Information Service, Kahramanmaras Sütçü Imam University, Faculty of Medicine, Avsar Kampusu, Onikisubat, Kahramanmaraş, Turkey.

Drug counseling is important in women with epilepsy since data about the effects of maternal antiepileptics on the developing fetus are limited. Although pregnant patients on the most teratogenic drugs are treated in accordance to the European Medicines Agency guidelines, a large amount of them may be exposed to the teratogenic medications unintentionally. We performed a tertiary center observational study about medications of pregnant women who were consulted to Teratology Information Service (TIS) unit for evidence-based teratogenic risk analysis. Read More

PLoS One 2019 18;14(10):e0223603. Epub 2019 Oct 18.

Department of Pediatrics, University of California San Diego, La Jolla, CA, United States of America.

Background: Information is needed on the safety of adalimumab when used in pregnancy for the treatment of certain autoimmune diseases.

Methods And Findings: Between 2004 and 2016, the Organization of Teratology Information Specialists Research Center at the University of California San Diego conducted a prospective controlled observational cohort study in 602 pregnant women who had or had not taken adalimumab. Women in the adalimumab-exposed cohort had received at least one dose of the drug in the first trimester for the treatment of rheumatoid arthritis or Crohn's Disease (N = 257). Read More

Br J Clin Pharmacol 2019 12 3;85(12):2856-2863. Epub 2019 Dec 3.

Department of Public Health, Ben-Gurion University of the Negev, Beer-Sheva, Israel.

Aims: The goal of the current study was to assess the risk for major congenital malformations following first-trimester exposure to amoxicillin, or amoxicillin and clavulanic acid (ACA).

Methods: A population-based retrospective cohort study was conducted, by linking 4 computerized databases: maternal and infant hospitalization records, drug dispensing database of Clalit Health Services in Israel and data concerning pregnancy terminations. Multivariate negative-binomial regression was used to assess the risk for major malformations following first-trimester exposure, adjusted for mother's age, ethnicity (Bedouin vs Jewish), parity, diabetes mellitus, lack of perinatal care, and the year of birth. Read More

Br J Clin Pharmacol 2019 11 19;85(11):2580-2590. Epub 2019 Aug 19.

Radboud REshape Innovation Center, Radboud University Medical Center, Nijmegen, The Netherlands.

Aims: An increasing number of women trust the Internet for information about medication safety during pregnancy. This study aimed to evaluate the availability and accuracy of social media content on the perceived safety of medication use in pregnancy.

Methods: We performed a systematic search of posts related to medication safety during pregnancy in the Dutch language published on social media, blogs and forums between May 2011 and April 2016 using Coosto, a tool for social media monitoring. Read More

Breastfeed Med 2019 11 1;14(9):674-679. Epub 2019 Aug 1.

MotherSafe, The Royal Hospital for Women, Sydney, New South Wales, Australia.

MotherSafe is a free telephone-based counseling service for Australian consumers and health care providers concerned about drug exposures during pregnancy and breastfeeding. Calls relating to breastfeeding are relatively common and a source of significant distress to the breastfeeding mother, particularly if there is a lack of clarity regarding possible adverse effects of drug exposure on the infant. This study seeks to identify the medication exposures of concern for breastfeeding mothers and the information available to address these concerns. Read More

Orphanet J Rare Dis 2019 07 19;14(1):180. Epub 2019 Jul 19.

Clinical Genetics, Royal Devon and Exeter NHS Foundation Trust, Gladstone Rd, Exeter, UK.

Background: A pattern of major and minor congenital anomalies, facial dysmorphic features, and neurodevelopmental difficulties, including cognitive and social impairments has been reported in some children exposed to sodium valproate (VPA) during pregnancy. Recognition of the increased risks of in utero exposure to VPA for congenital malformations, and for the neurodevelopmental effects in particular, has taken many years but these are now acknowledged following the publication of the outcomes of several prospective studies and registries. As with other teratogens, exposure to VPA can have variable effects, ranging from a characteristic pattern of major malformations and significant intellectual disability to the other end of the continuum, characterised by facial dysmorphism which is often difficult to discern and a more moderate effect on neurodevelopment and general health. Read More

Reprod Toxicol 2019 10 13;89:107-114. Epub 2019 Jul 13.

Department of Pharmacology, Federal University of Paraná, Centro Politécnico, PO Box 19031, Curitiba, PR, 81531-980, Brazil.

Malaria in pregnant women is associated with risk of maternal and perinatal morbidity and mortality, and there are few antimalarial drugs considered safe to treat them, so it is necessary to develop safer antimalarial medicines. The goal of this study was to develop an animal model for human malaria during pregnancy by characterizing the maternal and fetal outcomes in malaria infected Swiss mice. For that, in the present study, we evaluated the outcome of pregnancy in Swiss mice infected with Plasmodium berghei ANKA. Read More

J Eval Clin Pract 2020 Jun 12;26(3):911-917. Epub 2019 Jul 12.

Department of Pharmaceutical and Pharmacological Sciences, Clinical Pharmacology and Pharmacotherapy, KU Leuven, Leuven, Belgium.

Rationale, Aims, And Objective: In the absence of a Teratology Information Service in Belgium, the National Poison Centre might act as a substitute centre for answering pregnancy- and lactation-related questions regarding medication use. The aim of this study was to define the prevalence and characteristics of pregnancy- and lactation-related calls to the National Poison Centre in Belgium, as well as the type of health products involved during these calls.

Method: A retrospective, descriptive study on pregnancy- and lactation-related calls involving health products received by the Belgian Poison Centre between January 2012 and December 2017 was performed. Read More

Brain Behav 2019 07 29;9(7):e01334. Epub 2019 May 29.

Department of Veterinary Physiology and Pharmacology, College of Veterinary Medicine and Biomedical Sciences, Texas A&M University, College Station, Texas.

Introduction: Prenatal alcohol exposure can contribute to fetal alcohol spectrum disorders (FASD), characterized by a myriad of developmental impairments affecting behavior and cognition. Studies show that many of these functional impairments are associated with the hippocampus, a structure exhibiting exquisite vulnerability to developmental alcohol exposure and critically implicated in learning and memory; however, mechanisms underlying alcohol-induced hippocampal deficits remain poorly understood. By utilizing a high-throughput RNA-sequencing (RNA-seq) approach to address the neurobiological and molecular basis of prenatal alcohol-induced hippocampal functional deficits, we hypothesized that chronic binge prenatal alcohol exposure alters gene expression and global molecular pathways in the fetal hippocampus. Read More

Int J Mol Sci 2019 May 14;20(10). Epub 2019 May 14.

Maccabi Institute of Research and Innovation, Tel Aviv University, Tel Aviv, Israel and Ariel University, Ariel 40700, Israel.

Serotonin has important roles in the development of the brain and other organs. Manipulations of synaptic serotonin by drugs such as serotonin reuptake inhibitors (SRI) or serotonin norepinephrine reuptake inhibitors (SNRI) might alter their development and function. Of interest, most studies on the outcome of prenatal exposure to SRI in human have not found significant embryonic or fetal damage, except for a possible, slight increase in cardiac malformations. Read More

Reprod Toxicol 2019 08 9;87:42-49. Epub 2019 May 9.

Department of Veterinary Physiology and Pharmacology, College of Veterinary Medicine and Biomedical Sciences, Texas A&M University, College Station, TX, USA. Electronic address:

Binge alcohol exposure during pregnancy results in diminished vessel function and altered proteome in the maternal uterine artery. We aimed to utilize high throughput RNA-seq deep-sequencing to characterize specific effects of binge alcohol exposure during pregnancy on the uterine artery transcriptome, and gain insight into mechanisms underlying alcohol-mediated uterine artery dysfunction. Pregnant Sprague-Dawley rats assigned to Pair-Fed Control or Alcohol groups, received a once-daily orogastric gavage in a binge paradigm. Read More

Methods Mol Biol 2019 ;1965:421-434

Department of Physiology and Developmental Biology, College of Life Sciences, Brigham Young University, Provo, UT, USA.

Teratology is the study of anatomical and physiological abnormalities, commonly known as birth defects. If an embryo is exposed to a harmful substance, or teratogen, during the critical period of development, an ensuing malformation may occur. These malformations and their associated mechanisms are studied and analyzed in laboratory animals in order to prevent them from occurring in humans. Read More

Clin Perinatol 2019 06 28;46(2):203-213. Epub 2019 Mar 28.

Department of Pediatrics, University of California, San Diego, 9500 Gilman Drive, Mail Code #0828, La Jolla, CA 92039, USA. Electronic address:

Many conditions that require frequent medication use are common during pregnancy. The purpose of this article is to list some of the most common of these disorders and to discuss the risk to the developing fetus of the medications used most frequently to treat them. Included are drugs used for the treatment of asthma, nausea and vomiting, hyperthyroidism, pain and fever, and depression during pregnancy. Read More

Neurotoxicol Teratol 2019 May - Jun;73:31-41. Epub 2019 Mar 31.

Department of Psychology, Center for Behavioral Teratology, San Diego State University, San Diego, CA 92120, USA.

Cannabis is the most commonly used illicit drug among pregnant women, and rates are likely to increase given recent legalization. In addition, half of pregnant women who report consuming cannabis also report drinking alcohol. However, little is known about the consequences of prenatal cannabis alone or in combination with alcohol, particularly with cannabis products that are continually increasing in potency of the primary psychoactive constituent in cannabis, Δ9-tetrahydrocannabinol (THC). Read More

Birth Defects Res 2019 07 10;111(12):760-774. Epub 2019 Mar 10.

Department of Psychology, Center for Behavioral Teratology, San Diego State University, San Diego, California.

Cannabis is the most commonly used illicit drug among pregnant women. Moreover, over half of pregnant women who are consuming cannabis are also consuming alcohol; however, the consequences of combined prenatal alcohol and cannabis exposure on fetal development are not well understood. The current study examined behavioral development following exposure to ethanol (EtOH) and/or CP-55,940 (CP), a cannabinoid receptor agonist. Read More

Reprod Toxicol 2019 06 5;86:1-13. Epub 2019 Mar 5.

Mothersafe, The Royal Hospital for Women, Sydney, New South Wales, Australia; School of Women's and Children's Health University of New South Wales, Australia.

Aims: To investigate whether ondansetron use during pregnancy is associated with increased rates of major or subgroups of malformations.

Methods: PubMed/MEDLINE, Cochrane and Reprotox databases were searched. Observational studies comprising an exposed and control group (healthy and/or disease-matched) were included. Read More

Reprod Toxicol 2019 04 7;85:65-74. Epub 2019 Feb 7.

Izmir Katip Celebi University, Faculty of Medicine, Department of Pharmacology Izmir, Turkey; Terafar, Izmir Katip Celebi University Teratology Information, Training and Research Center, Izmir, Turkey.

Objective: To investigate whether maternal exposure to quinolones, fluoroquinolones and specifically ciprofloxacin is associated with major malformations and other adverse pregnancy outcomes.

Methods: MEDLINE/PubMed, Embase and Reprotox® databases were searched. Observational studies with an exposed and control group were included. Read More

Breast Cancer Res Treat 2019 May 1;175(1):17-25. Epub 2019 Feb 1.

Department of Gynecologic Oncology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.

Purpose: Breast cancer is the most common malignancy among young women of reproductive age. Adjuvant treatment with tamoxifen reduces the risk of recurrence in hormone-sensitive breast cancer. However, the use of tamoxifen is considered contraindicated during pregnancy, because of a limited number of case reports demonstrating potential adverse effects on the fetus. Read More

Arthritis Rheumatol 2019 06 2;71(6):901-907. Epub 2019 May 2.

University of California, San Diego.

Objective: To investigate whether the discontinuation of tumor necrosis factor inhibitors (TNFi) during pregnancy is associated with any changes of the disease course in women with rheumatoid arthritis (RA) and juvenile idiopathic arthritis (JIA).

Methods: Pregnant women with RA and JIA from the US and Canada were enrolled in the Organization of Teratology Information Specialists (OTIS) Autoimmune Diseases in Pregnancy Project, a prospective cohort study. Information about medication and disease activity (patient-reported outcome measures) was collected prior to gestational week 20 and at gestational week 32. Read More

Regul Toxicol Pharmacol 2019 Mar 3;102:74-78. Epub 2019 Jan 3.

Research Centre for Veterinary Toxicology (CEPTOX) - Department of Pathology, School of Veterinary Medicine and Animal Sciences, University of São Paulo, Pirassununga 05508-270, SP, Brazil. Electronic address:

Cynara scolymus (C.scolymus) is a plant employed worldwide as an herbal medicine. However, there is a paucity of data related to the evaluation of its toxicity in commercial preparations; thus, the aim of this study was to evaluate the possible teratogenic effect of the dry extract of C. Read More

Clin Epidemiol 2018 3;10:1801-1816. Epub 2018 Dec 3.

Pharmacoepidemiology and Drug Safety Research Group, School of Pharmacy, University of Oslo, 0316 Oslo, Norway,

Purpose: A reliable definition of exposure and knowledge about long-term medication patterns is important for drug safety studies during pregnancy. Few studies have investigated these measures for thyroid hormone replacement therapy (THRT). The purpose of this study was to 1) calculate the agreement between self-report and dispensed prescriptions of THRT and 2) classify women with similar adherence patterns to THRT into disjoint longitudinal trajectories. Read More

Neurotoxicol Teratol 2019 Jan - Feb;71:16-21. Epub 2018 Nov 16.

School of Life and Health Sciences, Aston University, Aston Triangle, Birmingham B4 7ET, UK; Clinical Sciences, Murdoch Children's Research Institute, Flemington Road, Parkville, Victoria 3052, Australia.

Background: An increased risk of impaired intelligence (IQ) has been documented in valproate-exposed children, but investigations have not previously focused on those with a clinical diagnosis of Fetal Valproate Syndrome (FVS).

Methods: This cross sectional observational study recruited individuals with a diagnosis of FVS and completed standardized assessments of intellectual abilities making comparisons to a normative comparison group. Both mean difference (MD) and prevalence of scores below the lower average range were analyzed. Read More

Reprod Toxicol 2018 10 24;81:237-245. Epub 2018 Aug 24.

Discipline of Biomedical Sciences, Sydney Medical School, The Unvieristy of Sydney, Sydney, NSW 2006, Australia. Electronic address:

The potent hERG channel blocking drug ondansetron is used off-label for treatment of nausea and vomiting in early pregnancy. Some human epidemiological studies have associated ondansetron with fetal cardiovascular defects and orofacial clefts. This study investigated the effects of ondanestron on embryonic heart rhythm of gestational day (GD) 13 rat embryos in vitro and then integrated the results with published animal teratology, and animal and human pharmacokinetic studies to perform a risk evaluation. Read More

Rheumatology (Oxford) 2018 07;57(suppl_5):v34-v39

Department of Pediatrics, Division of Dysmorphology and Teratology, University of California San Diego, La Jolla, CA, USA.

For the last 30 years, pregnancy exposure studies, with varying methodologies, have been the mainstay of post-marketing surveillance for new drugs likely to be used by women of reproductive age. While they provide valuable data to inform use during pregnancy, they have limitations that render them necessary but not sufficient in supplying timely information to patients and prescribers. The Organization of Teratology Information Specialists MotherToBaby Pregnancy Studies' collaborative research group operates to help fill this gap. Read More

Regul Toxicol Pharmacol 2018 Oct 27;98:108-114. Epub 2018 Jul 27.

R&D Safety Science Research, Kao Corporation, 2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, Japan.

Recent studies suggest that diets supplemented with alpha-linolenic acid (ALA)-enriched diacylglycerol (DAG) oil provide potential health benefits in preventing or managing obesity. However, available safety information about reproductive and developmental toxicities of ALA-DAG oil is limited. This study was conducted to clarify the effect, if any, of ALA-DAG oil on embryo-fetal development, following maternal exposure during the critical period of major organogenesis. Read More

Mol Psychiatry 2018 Jun 25. Epub 2018 Jun 25.

Neuropsychopharmacology Unit, Centre for Psychiatry, Imperial College London, London, UK.

Addiction has been proposed as a 'reward deficient' state, which is compensated for with substance use. There is growing evidence of dysregulation in the opioid system, which plays a key role in reward, underpinning addiction. Low levels of endogenous opioids are implicated in vulnerability for developing alcohol dependence (AD) and high mu-opioid receptor (MOR) availability in early abstinence is associated with greater craving. Read More

Reprod Toxicol 2018 09 22;80:35-43. Epub 2018 Jun 22.

Ellegaard Göttingen Minipigs, Dalmose, Denmark.

The minipig is accepted from scientific and regulatory perspectives for the safety evaluation of drug candidates on embryo-fetal development. The relative size and the duration of gestation (112-115 days) in the minipig is, however, considered a drawback compared with routine smaller species. We evaluated if study duration and cost could be optimized without impacting scientific validity by performing all terminal procedures around mid-gestation (60 days). Read More

Reprod Toxicol 2018 Sep 18;80:68-72. Epub 2018 Jun 18.

Swiss Teratogen Information Service and Service of Clinical Pharmacology, University Hospital of Lausanne, Switzerland.

The European Network of Teratology Information Services (ENTIS) is in a privileged position to perform independent post-marketing surveillance of drugs in pregnancy. The aim of this survey was to describe the legal requirements and procedures involved in obtaining ethical approval for collaborative cohort studies. We sent a survey questionnaire to all 28 Teratology Information Services (TIS), of which 25 (89%) in 18 countries completed our questionnaire. Read More

Reprod Toxicol 2018 Aug 13;79:79-83. Epub 2018 Jun 13.

Terafar - Izmir Katip Celebi University Teratology Information, Training and Research Center, Izmir, Turkey; Izmir Katip Celebi University School of Medicine, Department of Pharmacology Izmir, Turkey.

Objective: To investigate the pregnancy outcomes of women who were exposed to betahistine during their pregnancies.

Methods: We identified and evaluated the outcomes of 27 pregnant women who were referred to Terafar (Teratology Information Service, Izmir, Turkey) for a teratological risk assessment.

Results: Of 24 pregnancies with known outcomes, 21 resulted in live births (including two pairs of twins) whereas two ended with miscarriage and three with elective terminations. Read More

Reprod Toxicol 2018 08 6;79:66-71. Epub 2018 Jun 6.

Japan Drug Information Institute in Pregnancy, National Center for Child Health and Development Tokyo, Japan; Center for Maternal-Fetal, Neonatal and Reproductive Medicine, Department of Perinatology, National Center for Child Health and Development, Tokyo, Japan.

Objective: To confirm the current state of Japanese women's perception of the teratogenic risk of medication exposure during pregnancy, and to assess the effect of counseling by　Japan Drug Information Institute in Pregnancy.

Methods: We used VAS to monitor the sentiments of pregnant women, before and after face-to-face counseling, about their own teratogenic risk perception, and their intention to continue pregnancy. Pregnancy outcomes were investigated by mailed questionnaires. Read More

Reprod Toxicol 2018 Sep 29;80:85-91. Epub 2018 May 29.

The Hebrew University Hadassah Medical School, Jerusalem, Israel.

Objective: To evaluate the rate of major anomalies after first trimester (T1)-metformin exposure.

Design: Comparative, observational cohort study done at the Israeli Teratology Information Service between 2000 and 2013.

Results: 170 T1-metformin-exposed pregnancies [119 for diabetes and 51 for polycystic ovary syndrome (PCOS)] were prospectively followed-up and compared with 93 pregnancies of T1-insulin treated women and 530 non-teratogenic exposed (NTE) pregnancies. Read More

Minerva Ginecol 2018 Jun;70(3):261-267

Department of Women's and Children's Health, Sacro Cuore Catholic University, Agostino Gemelli University Hospital Foundation, Rome, Italy.

Background: The objective of the present study is to review the literature regarding the management of fertile patients under lithium treatment for bipolar disorder and to report the experience of our Teratology Information Service over the past thirteen years in managing women treated with lithium during preconception, pregnancy and breastfeeding.

Methods: This research focuses on a selective review of the literature and a retrospective survey has been carried out on fertile women under lithium treatment who called our service at A. Gemelli University Hospital in Rome from May 2002 to December 2015. Read More

Reprod Toxicol 2018 08 12;79:32-38. Epub 2018 May 12.

Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Institute of Clinical Pharmacology and Toxicology, Berlin, Germany.

Ibuprofen is an analgesic frequently used in the 1st and 2nd trimester of pregnancy. Most relevant studies deal with NSAID as a group and do not specifically focus on ibuprofen. In this study, 1117 women exposed to ibuprofen in the 1st trimester were compared to 2229 non-exposed women. Read More

Paediatr Drugs 2018 Aug;20(4):331-335

Faculty of Medicine, Hebrew University Hadassah Medical School, Jerusalem, Israel.

Since the inception of clinical teratology, the vast majority of scientific work has focused on identification of drugs and environmental agents causing malformations in humans as a dichotomous variable (i.e. yes or no), as well as the relative and absolute risks of such occurrences. Read More

Reprod Toxicol 2018 04 22;77:122-129. Epub 2018 Mar 22.

Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Clinical Pharmacology and Toxicology, Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Augustenburger Platz 1, 13353, Berlin, Germany. Electronic address:

Diclofenac is a widely used analgesic so that exposure during pregnancy may frequently occur. Most publications have evaluated the safety of NSAIDs on pregnancy outcome as a group of substances. Specific data on diclofenac are rare. Read More

Pharm Res 2018 Feb 6;35(3):46. Epub 2018 Feb 6.

Laboratory of Teratology, Department of Medical Neurobiology, Israel Canada Research Institute, Hebrew University Hadassah Medical School, 91120, Jerusalem, Israel.

Introduction: Attention deficit/hyperactivity disorder (ADHD) is a neurobehavioral problem found in 2-5% of adults. Stimulants and drugs that affect the dopaminergic, noradrenergic and/or serotonergic systems are effective treatment and are increasingly prescribed to women at child bearing age. It is consequently important that reliable information on the safety of these drugs in pregnancy is available so that appropriate therapeutic choices can be made. Read More

Reprod Toxicol 2018 03 1;76:84-92. Epub 2018 Feb 1.

Department of Veterinary Physiology and Pharmacology, College of Veterinary Medicine and Biomedical Sciences, Texas A&M University, College Station, TX 77843-4466, USA. Electronic address:

Fetal alcohol spectrum disorders (FASD) describe neurodevelopmental deficits in children exposed to alcohol in utero. We hypothesized that gestational alcohol significantly alters fetal brain regional protein signature. Pregnant rats were binge-treated with alcohol or pair-fed and nutritionally-controlled. Read More

Expert Opin Drug Metab Toxicol 2018 Mar 24;14(3):247-259. Epub 2018 Jan 24.

b Morris Kahn- Maccabi Institute of Research and Innovation, and Tel Aviv University , TEl - AVIV , Israel.

Introduction: Possible negative effects of selective serotonin reuptake inhibitors (SSRIs) in pregnancy relate to congenital anomalies, negative perinatal events and neurodevelopmental outcome. Many studies are confounded by the underlying maternal disease and by pharmacogenetic and pharmacokinetic differences of these drugs. Areas covered: The possible interactions of SSRIs and serotonin and norepinephrine reuptake inhibitors with other drugs and the known effects of SSRIs on congenital anomalies, perinatal and neurodevelopmental outcome. Read More

Br J Clin Pharmacol 2018 05 6;84(5):1081-1082. Epub 2018 Jan 6.

Izmir Katip Celebi University, Faculty of Medicine, Department of Pharmacology, Izmir, Turkey.

Br J Clin Pharmacol 2018 03 14;84(3):568-578. Epub 2018 Jan 14.

Department of Epidemiology, Harvard School of Public Health, Boston, Massachusetts, USA.

Aims: Metformin is used to treat type 2 diabetes, polycystic ovary syndrome associated infertility, and gestational diabetes. This study aims to evaluate the safety of metformin in early pregnancy.

Method: We evaluated the risk of major birth defects and pregnancy losses in a cohort of pregnant women exposed to metformin during the first trimester for different indications relative to a matched unexposed reference group. Read More