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Reprod Toxicol 2019 Feb 7. 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

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

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 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

Congenit Anom (Kyoto) 2017 Nov;57(6):176-177

Toxicology Division, Institute of Environmental Toxicology, Joso, Japan.

Curr Drug Saf 2018 ;13(1):3-11

Teratology Information Service, Department of Obstetrics and Gynecology, Fetal Diagnosis and Therapy Unit, Catholic University of Sacred Heart, Policlinico A. Gemelli Hospital, Rome, Italy.

Background: There are many contradictions about pregnancy and fetal/neonatal outcomes after topical use of timolol alone or timolol in combination with other antiglaucoma medications.

Methods: Seventy-five pregnant women exposed to antiglaucoma medications were followed prospectively by phone interviews. 27 women used timolol as monotherapy, 48 women used timolol as a part of multidrug therapy. Read More

Eur J Clin Pharmacol 2018 Feb 24;74(2):171-179. Epub 2017 Oct 24.

Charité Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie, Institut für Klinische Pharmakologie und Toxikologie, Augustenburger Platz 1, 13353, Berlin, Germany.

Since 1988, the German Embryotox institute combines individual counselling of pregnant women and their health care providers (HCP) with research on drug safety in pregnancy. In addition, Embryotox offers web-based information which covers the most important and most frequently requested pharmaceutical substances. In contrast to ready-made drug risk information in package leaflets and other product information, individual counselling considers different clinical settings such as (1) looking for a drug of choice or planning pregnancy under medication, (2) risk assessment of a particular drug that has already been taken during an (unplanned) pregnancy and (3) evaluation of an adverse pregnancy outcome in association with a particular medication. Read More

Pediatr Endocrinol Rev 2017 Sep;15(1):4-7

Neonatal Intensive Care Unit, Schneider Children's Medical Center of Israel and Beilinson Teratology Information Service, Rabin Medical Center, Petah Tikva, Israel, the Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.

Cannabis, commonly called marijuana, is often used during pregnancy, likely due to the perception that it is a "safe" drug. Changes in legislation in many countries have lead to the increased availability of this drug and to its increasing use during pregnancy, often with other concomitant exposures such as alcohol, tobacco, and other drugs. Herein, we review the medical literature regarding effects of marijuana on the fetus and newborn. Read More

Int J Mol Sci 2017 Aug 7;18(8). Epub 2017 Aug 7.

Department of Chemistry, Tamkang University, No. 151 Ying-chuan Road, Tamsui, New Taipei City 25137, Taiwan.

Topiramate is commonly used for treating epilepsy in both children and adults. Recent clinical data suggests that administration of topiramate to women during pregnancy increases the risk of oral clefts in their offspring. To better understand the potential effects of topiramate, we dosed adult female zebrafish with topiramate, and investigated the altered morphologies in adult females and their offspring. Read More

Front Pharmacol 2017 17;8:402. Epub 2017 Jul 17.

Research Center, CHU Sainte-JustineMontreal, QC, Canada.

Polymorphic expression of drug metabolizing enzymes affects the metabolism of antidepressants, and thus can contribute to drug response and/or adverse events. Pregnancy itself can affect CYP2D6 activity with profound variations determined by genotype. To investigate the association between genotype and the risk of antidepressant discontinuation, dosage modification, and the occurrence of maternal , Antidepressants, Depression during pregnancy. Read More

Birth Defects Res 2017 Jul;109(12):898-908

Laboratory of Teratology, Department of Medical Neurobiology, Hebrew University Hadassah Medical School Jerusalem and Maccabi Research Institute and Tel Aviv University, Tel Aviv, Israel.

Despite extensive studies, there still seems to be uncertainty as to the possible reproductive risk of selective serotonin reuptake inhibitors (SSRIs) and selective serotonin norepinephrine reuptake inhibitors (SNRIs) in pregnancy. We, therefore, assess the current data on the risk/benefit of SSRI use in pregnancy. As the neurodevelopmental effects of SSRIs are discussed in another paper in this issue, we will not address the possible neurodevelopmental effects. Read More

Birth Defects Res 2017 Jul;109(12):933-956

Laboratory of Teratology, Department of Medical Neurobiology, Hebrew University Hadassah Medical School, Jerusalem, Israel.

Depression is generally treated with antidepressants, but may often need antipsychotics and mood stabilizers. We discuss the updated data regarding the safety in pregnancy of antidepressants and antipsychotics, except selective serotonin reuptake inhibitors, and their possible impact on the long-term development of the offspring. Several earlier studies demonstrated a slight increase in the rate of major anomalies following maternal tricyclic antidepressant treatment, but most current literature shows their relative safety in pregnancy. Read More

Oncol Res Treat 2017 13;40(7-8):441-445. Epub 2017 Jul 13.

Background: The use of chemotherapeutics during pregnancy is a dilemma for both the patient and the clinician. We report here our 11 years' experience with the use of chemotherapy during pregnancy.

Patients: 13 patients undergoing chemotherapy during their current pregnancy were evaluated. Read More

Birth Defects Res 2017 Sep 28;109(15):1196-1203. Epub 2017 Jun 28.

The Hebrew University Hadassah Medical School, Jerusalem, Israel.

Background: Lamotrigine is a second-generation antiepileptic drug, also used as a mood stabilizer. Published data on its use in human pregnancy are largely derived from pregnancy registries. Pregnancy experience in most studies has been reassuring. Read More

Int J Clin Pharm 2017 Aug 19;39(4):783-790. Epub 2017 Jun 19.

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

Background Previous studies from western countries demonstrated the effectiveness of Teratology Information Service (TIS) counselling in reducing the teratogenic risk perception of pregnant women. Objective To assess whether TIS counselling would be effective in reducing the teratogenic risk perception of the Turkish pregnant women. Setting A TIS (Terafar) operating in a university hospital in Turkey. Read More

Expert Opin Drug Saf 2017 Aug 23;16(8):915-921. Epub 2017 Jun 23.

a Department of Obstetrics and Gynecology, Institute of Clinical Medicine , Aarhus University & Aarhus University Hospital , Aarhus , Denmark.

Introduction: The prevalence of depression in pregnancy is over 10% and a significant proportion of pregnant women use antidepressant medication. The safety of antidepressants in pregnancy is controversial, partly due to methodological challenges. The conflicting results in the literature may, however, also be due to differences in risks between the study populations related to variations in e. Read More

Reprod Toxicol 2017 08 25;71:146-149. Epub 2017 May 25.

Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Charité Universitätsmedizin, Berlin, Campus Virchow-Klinikum, Augustenburger Platz 1, 13353 Berlin, Germany. Electronic address:

Pregnancy-associated diffuse large B-cell lymphoma (DLBCL) is a rare event. Experience regarding fetal effects of maternal treatment during pregnancy is limited. Cardiotoxicity is a known adverse effect of some antineoplastic agents especially of doxorubicin. Read More

Reprod Toxicol 2017 09 8;72:191-200. Epub 2017 May 8.

Laboratory of Teratology, Department of Medical Neurobiology, Hebrew University Hadassah Medical School, Jerusalem, Israel. Electronic address:

During the last twenty years, in spite of extensive literature regarding the use of SSRIs in pregnancy, confusion still exists as to possible long-term risks of these drugs on the offspring. Possible negative effects relate to neurodevelopmental outcome and association with Autism Spectrum Disorder (ASD). Most neurodevelopmental follow up studies did not find significant cognitive impairment except from some apparently transient, gross motor delay and slight impairment of language abilities. Read More

Isr Med Assoc J 2016 Jul;18(7):379-380

Department of Obstetrics.

J Psychopharmacol 2017 05 25;31(5):519-552. Epub 2017 Apr 25.

12 South London and Maudsley NHS Foundation Trust, London, UK.

Decisions about the use of psychotropic medication in pregnancy are an ongoing challenge for clinicians and women with mental health problems, owing to the uncertainties around risks of the illness itself to mother and fetus/infant, effectiveness of medications in pregnancy and risks to the fetus/infant from in utero exposure or via breast milk. These consensus guidelines aim to provide pragmatic advice regarding these issues. They are divided into sections on risks of untreated illness in pregnancy; general principles of using drugs in the perinatal period; benefits and harms associated with individual drugs; and recommendations for the management of specific disorders. Read More

Birth Defects Res 2017 Apr 9;109(6):423-431. Epub 2017 Mar 9.

Research Center, CHU Sainte-Justine, Montreal, Canada.

Background: Administrative databases are increasingly used to measure drug exposure in perinatal pharmacoepidemiology. We aimed to estimate the concordance between records of prescriptions filled in pharmacies and self-reported drug use during pregnancy.

Methods: Data on self-reported medication use were collected at each trimester of pregnancy among a sub-sample from the Organization of Teratology Information Specialists Antidepressants in Pregnancy Cohort. Read More

Minerva Ginecol 2018 Jun 10;70(3):303-322. Epub 2017 Apr 10.

Department of Medicine and Aging Sciences, G. d'Annunzio University of Chieti-Pescara, Chieti, Italy -

Valproic acid (VPA) is an anti-epileptic drug (AED) which is currently being investigated for its potential application in the treatment of several types of cancers, including solid and non-solid tumor. It is well-known that prenatal exposure to VPA largely increases the risk for malformations and other developmental disorders. This review concentrates on clinical and experimental data on congenital anomalies attributed to maternal VPA exposure. Read More

Food Chem Toxicol 2017 May 10;103:203-213. Epub 2017 Mar 10.

Division of Molecular Biology, Center for Food Safety & Applied Nutrition, U.S. Food & Drug Administration, College Park, MD 20740, United States.

Paenibacillus alvei, a naturally occurring soil microorganism, may be used in the control and/or elimination of human/animal pathogens present on/within produce commodities associated with human consumption. The safety of oral exposure to P. alvei in male, nulliparous females, the pregnant dam and developing fetus was assessed. Read More

Drug Saf 2017 05;40(5):387-397

Division of Evolution and Genomic Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.

Introduction: Electronic healthcare data have several advantages over prospective observational studies, but the sensitivity of data on neurodevelopmental outcomes and its comparability with data generated through other methodologies is unknown.

Objectives: The objectives of this study were to determine whether data from the UK Clinical Practice Research Datalink (CPRD) produces similar risk estimates to a prospective cohort study in relation to the risk of neurodevelopmental disorders (NDDs) following prenatal antiepileptic drug (AED) exposure.

Methods: A cohort of mother-child pairs of women with epilepsy (WWE) was identified in the CPRD and matched to a cohort without epilepsy. Read More

Reprod Toxicol 2017 01 30;67:79-84. Epub 2016 Nov 30.

Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie (Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy), Charité Universitätsmedizin Berlin, Berlin, Germany.

All women of reproductive age should have access to Teratology Information Services (TIS). Observational cohort studies based on TIS data are one of the most important sources for risk characterization of drugs during pregnancy. A selection in TIS populations towards higher socioeconomic level would compromise the TIS' goal of health prevention and the quality of research. Read More

Neurotoxicol Teratol 2017 Jan - Feb;59:43-52. Epub 2016 Nov 23.

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

Prenatal alcohol exposure can cause a range of physical and behavioral alterations; however, the outcome among children exposed to alcohol during pregnancy varies widely. Some of this variation may be due to nutritional factors. Indeed, higher rates of fetal alcohol spectrum disorders (FASD) are observed in countries where malnutrition is prevalent. Read More

Drug Des Devel Ther 2016 10;10:3681-3683. Epub 2016 Nov 10.

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

Am J Clin Nutr 2016 12 2;104(6):1683-1692. Epub 2016 Nov 2.

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

Background: Prenatal alcohol exposure results in a broad range of cognitive and behavioral impairments. Because of the long-lasting problems that are associated with fetal alcohol spectrum disorders (FASDs), the development of effective treatment programs is critical. Preclinical animal studies have shown that choline, which is an essential nutrient, can attenuate the severity of alcohol-related cognitive impairments. Read More

Thyroid 2017 03 22;27(3):434-439. Epub 2016 Dec 22.

3 Section of Endocrinology, Diabetes and Nutrition, Boston University School of Medicine , Boston, Massachusetts.

Background: Iodine deficiency is a major public-health problem throughout the world, especially for pregnant women, and it is considered the most common cause of preventable intellectual impairment. In the United States, iodine status in pregnant women is considered mildly deficient. Therefore, the Endocrine Society, the American Thyroid Association, the Teratology Society, and the American Academy of Pediatrics recommend that women receive prenatal vitamins containing 150 μg of iodine daily during preconception, pregnancy, and lactation. Read More

J Clin Psychiatry 2016 09;77(9):1176-1181

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

Introduction: Methylphenidate is a central nervous system stimulant medicinally used in the treatment of attention-deficit disorder with or without hyperactivity (ADD/ADHD). Data on its use in human pregnancy are limited. The primary objective of the study was to evaluate the risk of major congenital anomalies after pregnancy exposure to methylphenidate for medical indications. Read More

Cleft Palate Craniofac J 2016 11 17;53(6):720-726. Epub 2015 Nov 17.

Objective: Although numerous studies have confirmed that consumption of folic acid (FA) during early pregnancy reduces the risk of oral facial clefts in newborn infants, the optimal dose of FA for reducing this risk remains unknown. We evaluated various doses of FA for their ability to reduce the incidence of all-trans retinoic acid (ATRA)-induced cleft palate in mice.

Methods: Pregnant C57BL/6J mice were randomly assigned to eight groups dosed with corn oil (control group), ATRA (80 mg/kg), FA (40 mg/kg), or ATRA (80 mg/kg) + FA (2. Read More

Toxicol Pathol 2017 01 5;45(1):107-113. Epub 2016 Oct 5.

1 Toxicology Branch, National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina, USA.

Regulatory studies of developmental and reproductive toxicity (DART) studies have remained largely unchanged for decades, with exposures occurring at various phases of the reproductive cycle and toxicity evaluations at different ages/times depending on the study purpose. The National Toxicology Program has conducted studies examining the power to detect adverse effects where there is a prenatal exposure, but evaluations occur postnatally. In these studies, examination is required of only 1 male and female pup from each litter beyond weaning. Read More

Health Technol Assess 2016 10;20(74):1-268

Health Economics Group, Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK.

Background: Nausea and vomiting in pregnancy (NVP) affects up to 85% of all women during pregnancy, but for the majority self-management suffices. For the remainder, symptoms are more severe and the most severe form of NVP - hyperemesis gravidarum (HG) - affects 0.3-1. Read More

Eur J Med Genet 2017 Jan 10;60(1):55-64. Epub 2016 Oct 10.

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

The fetal alcohol spectrum of disorders (FASD) includes four diagnostic categories for the clinical consequences of prenatal alcohol exposure (PAE) in the unborn child. Physical features are necessary for the diagnosis of the fetal alcohol syndrome (FAS) and partial pFAS. Moreover, these features are specific and a diagnosis of FAS can be made even in the absence of knowledge of PAE. Read More

Eur J Med Genet 2017 Jan 13;60(1):72-78. Epub 2016 Sep 13.

Division of Dysmorphology and Teratology, Department of Pediatrics, University of California, San Diego, USA; Clinical Genetics, Vall d'Hebron Hospital, UAB, Barcelona, Spain.

Fetal alcohol spectrum disorders (FASD) cause neurodevelopmental abnormalities. However, publications about epilepsy and electroencephalographic features are scarce. In this study, we prospectively performed electroencephalography (EEG) and brain magnetic resonance (MR) imaging in 61 patients with diagnosis of FASD. Read More