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Alcohol Clin Exp Res 2022 Jun 20. Epub 2022 Jun 20.

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

Background: It has been well established that prenatal alcohol exposure can lead to a wide range of neurological and behavioral deficits, including alterations in motor domains. However, much less is known about the effects of prenatal cannabis exposure on motor development, despite the fact that cannabis is the most commonly consumed illicit drug among women. Cannabis use among pregnant women has become increasingly popular given the wide-spread perception that consumption is safe during pregnancy. Read More

Spat Spatiotemporal Epidemiol 2022 Jun 29;41:100480. Epub 2022 Jan 29.

Division of Psychiatry, University of Western Australia, Crawley, Western Australia 6009, Australia; School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia 6027, Australia.

Background: Reports of major limb defects after prenatal cannabis exposure (PCE) in animals and of human populations in Hawaii, Europe and Australia raise the question of whether the increasing use of cannabis in USA might be spatiotemporally associated with limb reduction rates (LRR) across USA.

Methods: Congenital anomaly data was from the National Birth Defects Prevention Network, drug use data was taken from the National Survey of Drug Use and Health (NSDUH), cannabinoid concentration was estimated from Federal seizure data and ethnicity and income data were from the US Census bureau. Geotemporospatial analysis was conducted in R. Read More

Yakugaku Zasshi 2022 ;142(6):581-583

Japan Drug Information Institute in Pregnancy, National Center of Child Health and Development.

The Japan Drug Information Institute in Pregnancy (JDIIP) was established in 2005 as a project of the Ministry of Health, Labour and Welfare with the aims of providing information on drug safety to women who are worried about drug use during pregnancy and creating evidence through epidemiological studies based on counseling cases. Since being established, JDIIP has made many contributions to the wellness of mothers and children by promoting the proper use of drugs during pregnancy. However, some studies have shown that this alone is not enough to meet potential needs. Read More

Reprod Toxicol 2022 May 26;111:129-134. Epub 2022 May 26.

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

Women and their health care provider (HCP) often seek advice for drug safety in pregnancy at Teratology Information Services (TIS). In turn, TIS ask for details of drug exposure and pregnancy outcome. These data constitute a valuable basis for research on prenatal drug risks in many countries. Read More

Arch Gynecol Obstet 2022 May 27. Epub 2022 May 27.

Department of Medical Pharmacology, Dokuz Eylul University Faculty of Medicine, Izmir, Turkey.

Purpose: As in vitro and in vivo studies reported antiviral efficacy against RNA viruses, favipiravir, a pyrazinecarboxamide derivative, has become one of the treatment options for COVID-19 in some countries including Turkey. Preclinical studies demonstrated the risk for teratogenicity and embryotoxicity. Hence, the drug is contraindicated during pregnancy. Read More

J Reprod Immunol 2022 May 10;152:103639. Epub 2022 May 10.

Pharmacoepidemiology and Drug Safety Research Group, Department of Pharmacy, and PharmaTox Strategic Initiative, Faculty of Mathematics and Natural Sciences, University of Oslo, Norway; Department of Child Health and Development, Norwegian Institute of Public Health, Norway.

Int J Environ Res Public Health 2022 04 27;19(9). Epub 2022 Apr 27.

Teratology Information Service, Pharmacovigilance Centre Lareb, 's Hertogenbosch, 5237 MH Hertogenbosch, The Netherlands.

Information on medication utilization among pregnant and postpartum women during the pandemic is lacking. We described the prevalence and patterns of self-reported medication use among pregnant and postpartum women during the third wave of the pandemic (June-August 2021). An online questionnaire was distributed in five European countries between June-August 2021. Read More

Front Neurosci 2022 16;16:866722. Epub 2022 Mar 16.

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

Nicotine and cannabis are two of the most commonly consumed licit and illicit drugs during pregnancy, often consumed together e-cigarettes. Vaping is assumed to be a safer alternative than traditional routes of consumption, yet the potential consequences of prenatal e-cigarette exposure are largely unknown, particularly when these two drugs are co-consumed. In a novel co-exposure model, pregnant Sprague-Dawley rats received nicotine (36 mg/mL), tetrahydrocannabinol (THC) (100 mg/mL), the combination, or the vehicle e-cigarettes daily from gestational days 5-20, mimicking the first and second human trimesters. Read More

Psychopharmacology (Berl) 2022 May 26;239(5):1579-1591. Epub 2022 Mar 26.

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

Rationale: In the USA, nicotine and cannabis are the most common licit and illicit drugs used among pregnant women. Importantly, nicotine and cannabis are now being combined for consumption via e-cigarettes, an increasingly popular delivery device. Both nicotine and tetrahydrocannabinol (THC), the primary psychoactive component of cannabis, cross the placenta barrier. Read More

Obstet Gynecol Sci 2022 Mar 23;65(2):166-175. Epub 2022 Feb 23.

Korean Mothersafe Counselling Center, Pregnancy & Breastfeeding Medicines Information Center, Seoul, Korea.

Objective: Isotretinoin should not be used during pregnancy because of the risk of birth defects. Most pregnant women exposed to isotretinoin choose voluntary pregnancy termination due to concerns about birth defects. However, birth outcome data supporting the termination of pregnancy are lacking. Read More

Pediatr Infect Dis J 2022 05;41(5):e223-e227

From the Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.

Background: There is weak evidence on the best treatment of pregnant women with Toxoplasma gondii infection to prevent the vertical transmission to the fetus.

Methods: We conducted a 28-year retrospective study aiming to compare the efficacy of three therapeutic regimens [Spiramicyn alone (Spy) vs. Pyrimethamine-Sulfadiazine (P/S) vs. Read More

Int J Environ Res Public Health 2022 01 26;19(3). Epub 2022 Jan 26.

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

Insight into the epidemiology of perinatal medication use during the COVID-19 pandemic is scarce. Therefore, a cross-sectional study using an anonymous web survey was performed in Ireland, Norway, Switzerland, The Netherlands, and United Kingdom (UK) to investigate the prevalence and type of medications used by pregnant and breast-feeding women during the first pandemic wave. Factors associated with medication use were estimated by logistic regression. Read More

Epilepsy Behav 2022 02 15;127:108533. Epub 2022 Jan 15.

MassGeneral Hospital for Children, Medical Genetics Unit, Boston, MA, United States.

Objective: Usage during pregnancy of the antiseizure medication (ASM), phenobarbital (PB), carbamazepine (CBZ), and phenytoin (PHT), has been associated with adverse pregnancy outcomes. While morphological effects on offspring are well-documented, inconsistent findings have been reported on neuropsychological development, possibly due to differences in attention to maternal demographics, and other design characteristics. Herein, we report the results of a carefully designed protocol used to examine the effects of gestational monotherapy with PB, CBZ, or PHT upon children's general mental abilities, when compared to age- and gender- matched children born to unexposed women of similar age, education, and socioeconomic status. Read More

Am J Obstet Gynecol 2022 Jan 12. Epub 2022 Jan 12.

Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL; Center for Drug Evaluation and Safety (CoDES), University of Florida, Gainesville, FL; Department of Epidemiology, College of Medicine and College of Public Health and Health Professions, University of Florida, Gainesville, FL. Electronic address:

Background: Prevention of prenatal exposures to teratogenic drugs is a significant clinical and public health concern. With the enactment of the US Food and Drug Administration Amendments Act in 2007, the US Food and Drug Administration has begun to require manufacturers to implement Risk Evaluation and Mitigation Strategies to prevent prenatal exposures. Among 12 risk evaluation and mitigation strategy drugs, several had predecessor risk mitigation plans (eg, isotretinoin) and some were newly required (eg, mycophenolate). Read More

Bioinformatics 2021 Nov 15. Epub 2021 Nov 15.

Clinical Pharmacology and Toxicology Unit, Drug Consultation Center, Shamir Medical Center (Assaf Harofeh), Zerifin TIS, affiliated with the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv.

Motivation: Teratogenic drugs can cause severe fetal malformation and therefore have critical impact on the health of the fetus, yet the teratogenic risks are unknown for most approved drugs. This paper proposes an explainable machine learning model for classifying pregnancy drug safety based on multimodal data and suggests an orthogonal ensemble for modeling multimodal data. To train the proposed model, we created a set of labeled drugs by processing over 100,000 textual responses collected by a large teratology information service. Read More

Arthritis Rheumatol 2022 04 10;74(4):711-724. Epub 2022 Mar 10.

University of California San Diego.

Objective: Findings from previous small studies have been reassuring regarding the safety of treatment with hydroxychloroquine (HCQ) during pregnancy. In one recent study, it was demonstrated that the frequency of major birth defects was increased in women who had received HCQ at a dose of ≥400 mg/day during pregnancy. This study was undertaken to examine pregnancy outcomes among women following the use of HCQ. Read More

Alcohol Clin Exp Res 2021 11 29;45(11):2246-2255. Epub 2021 Sep 29.

Division of Medical Sciences, University of Victoria, Victoria, British Columbia, Canada.

Background: We recently showed that alcohol and cannabis can interact prenatally, and in a recent review paper, we identified parvalbumin-positive (PV) interneurons in the hippocampus as a potential point of convergence for these teratogens.

Methods: A 2 (Ethanol [EtOH], Air) × 2 (tetrahydrocannabinol [THC], Vehicle) design was used to expose pregnant Sprague-Dawley rats to either EtOH or air, in addition to either THC or the inhalant vehicle solution, during gestational days 5-20. Immunohistochemistry was performed to detect PV interneurons in 1 male and 1 female pup from each litter at postnatal day 70. Read More

BMC Pregnancy Childbirth 2021 Sep 1;21(1):593. Epub 2021 Sep 1.

Key Laboratory of Birth Defects And Related Diseases of Women and Children (Sichuan University), Ministry of Education, Chengdu, Sichuan, China.

Background: As reported, 27-93 % of pregnant women take at least one drug during pregnancy. However, drug exposure during pregnancy still lacks sufficient foetal safety evidence of human origin. It is urgent to fill the knowledge gap about medication safety during pregnancy for optimization of maternal disease treatment and pregnancy drug consultation. Read More

Curr Neuropharmacol 2021 ;19(11):1825-1834

Division of Neuroscience and Experimental Psychology, School of Biological Sciences, Faculty of Medicine, Biology and Health, University of Manchester, Manchester, United Kingdom.

Exposure in the womb to antiseizure medications and their potential impact on the brain of the developing child has long been researched. Despite this long period of interest, this review highlights that above the well-known risks associated with valproate exposure, there are more data required for conclusions regarding all other antiseizure medications. Limited experience with phenytoin and phenobarbital in monotherapy makes clearly defining the risk to later child postnatal functioning difficult, although the evidence of an impact is stronger for phenobarbital than for phenytoin. Read More

Glob Health Med 2021 Jun;3(3):175-179

Japan Drug Information Institute in Pregnancy, National Center of Child Health and Development, Tokyo, Japan.

The Japan Drug Information Institute in Pregnancy (JDIIP) was established with the aims of providing information on drug safety to women who are worried about drug use during pregnancy and creating evidence through epidemiological studies based on counseling cases. Since being established, JDIIP has made many contributions to the wellness of mothers and children by promoting the proper use of drugs during pregnancy. A network consisting of Core hospitals in 47 prefectures plays an important role in providing information for women living anywhere in Japan. Read More

Viruses 2021 06 22;13(7). Epub 2021 Jun 22.

Department Woman-Mother-Child, Lausanne University Hospital and University of Lausanne, 1011 Lausanne, Switzerland.

As pregnant women are at high risk of severe SARS-CoV-2 infection and COVID-19 vaccines are available in Switzerland, this study aimed to assess the willingness of Swiss pregnant and breastfeeding women to become vaccinated. Through a cross-sectional online study conducted after the first pandemic wave, vaccination practices and willingness to become vaccinated against SARS-CoV-2 if a vaccine was available were evaluated through binary, multi-choice, and open-ended questions. Factors associated with vaccine willingness were evaluated through univariable and multivariable analysis. Read More

Eur J Clin Pharmacol 2021 Nov 8;77(11):1737-1745. 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 Sep 8;20(9):1117-1124. 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

Alcohol Clin Exp Res 2021 07 1;45(7):1408-1423. Epub 2021 Jul 1.

Department of Neurobiology and Developmental Sciences, University of Arkansas for Medical Sciences, Little Rock, AR, USA.

Background: The developing hippocampus and cerebellum, unique among brain regions, exhibit a secondary surge in neurogenesis during the third trimester of pregnancy. Ethanol (EtOH) exposure during this period is results in a loss of tissue volume and associated neurobehavioral deficits. However, mechanisms that link EtOH exposure to teratology in these regions are not well understood. Read More

Clin Toxicol (Phila) 2022 Feb 28;60(2):175-183. 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

Curr Neuropharmacol 2022 Mar;20(3):579-593

Laboratório de Neuroquímica e Psicofarmacologia, Escola de Ciências da Saúde e da Vida, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, RS, Brazil.

Background: The consequences of mild to severe exposure to alcohol during brain development is still a matter of debate and scientific investigation. The long-term behavioural effects of ethanol exposure have been related to impaired social skills and cognition. Zebrafish have become a suitable animal model to investigate the effects of early ethanol exposure because it is very feasible to promote drug delivery during early development. 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.

Curr Neuropharmacol 2021 ;19(11):1805-1824

University of Health Sciences, Izmir Tepecik Training and Research Hospital, Teratology Information Center, Izmir, Turkey.

It is challenging to balance the fetal risks associated with the use of antiepileptic drugs (AEDs) against maternal and fetal risks of seizure worsening, and therefore it is very important to define and distinguish the possible risks entailed by different AEDs. This paper aims to undertake a comprehensive review regarding the possible risks of four classical (phenytoin, carbamazepine, phenobarbital, and valproate) and two newer (lamotrigine and levetiracetam) AEDs during pregnancy. The review focuses on major and organ-specific malformations, dose-dependent risks, mono vs polytherapy, and clinical pharmacokinetics. Read More