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Tytuł pozycji:

Negligible risk of prenatal ductus arteriosus closure or fetal renal impairment after third-trimester paracetamol use: evaluation of the German Embryotox cohort.

Tytuł :
Negligible risk of prenatal ductus arteriosus closure or fetal renal impairment after third-trimester paracetamol use: evaluation of the German Embryotox cohort.
Autorzy :
Dathe K; Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institut für Klinische Pharmakologie und Toxikologie, Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie, Berlin, Germany.
Frank J; Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institut für Klinische Pharmakologie und Toxikologie, Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie, Berlin, Germany.
Padberg S; Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institut für Klinische Pharmakologie und Toxikologie, Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie, Berlin, Germany.
Hultzsch S; Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institut für Klinische Pharmakologie und Toxikologie, Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie, Berlin, Germany.
Meixner K; Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institut für Klinische Pharmakologie und Toxikologie, Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie, Berlin, Germany.
Beck E; Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institut für Klinische Pharmakologie und Toxikologie, Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie, Berlin, Germany.
Meister R; Department of Mathematics, Beuth Hochschule für Technik-University of Applied Sciences, Berlin, Germany.
Schaefer C; Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institut für Klinische Pharmakologie und Toxikologie, Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie, Berlin, Germany.
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Źródło :
BJOG : an international journal of obstetrics and gynaecology [BJOG] 2019 Dec; Vol. 126 (13), pp. 1560-1567. Date of Electronic Publication: 2019 Aug 07.
Typ publikacji :
Journal Article; Observational Study; Research Support, Non-U.S. Gov't
Język :
English
Journal Info :
Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 100935741 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1471-0528 (Electronic) Linking ISSN: 14700328 NLM ISO Abbreviation: BJOG Subsets: Core Clinical (AIM); MEDLINE
Imprint Name(s) :
Publication: : Oxford : Wiley-Blackwell
Original Publication: Oxford [England] : Blackwell Science, [2000]-
MeSH Terms :
Acetaminophen/*administration & dosage
Analgesics, Non-Narcotic/*administration & dosage
Ductus Arteriosus, Patent/*chemically induced
Kidney/*drug effects
Kidney Diseases/*chemically induced
Acetaminophen/adverse effects ; Adult ; Analgesics, Non-Narcotic/adverse effects ; Ductus Arteriosus, Patent/embryology ; Female ; Humans ; Infant, Newborn ; Kidney/abnormalities ; Kidney/embryology ; Kidney Diseases/embryology ; Pregnancy ; Pregnancy Trimester, Third ; Retrospective Studies ; Risk Assessment
References :
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Moise KJ Jr. Effect of advancing gestational age on the frequency of fetal ductal constriction in association with maternal indomethacin use. Am J Obstet Gynecol 1993;168:1350-3.
Vermillion ST, Scardo JA, Lashus AG, Wiles HB. The effect of indomethacin tocolysis on fetal ductus arteriosus constriction with advancing gestational age. Am J Obstet Gynecol 1997;177:256-9.
Kirshon B, Moise KJ Jr, Mari G, Willis R. Long-term indomethacin therapy decreases fetal urine output and results in oligohydramnios. Am J Perinatol 1991;8:86-8.
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Allegaert K, Mian P, Lapillonne A, van den Anker JN. Maternal paracetamol intake and fetal ductus arteriosus constriction or closure: a case series analysis. Br J Clin Pharmacol 2019;85:245-51.
Becquet O, Bonnet D, Ville Y, Allegaert K, Lapillonne A. Paracetamol/acetaminophen during pregnancy induces prenatal ductus arteriosus closure. Pediatrics 2018;142:e20174021.
El-Farrash RA, El Shimy MS, El-Sakka AS, Ahmed MG, Abdel-Moez DG. Efficacy and safety of oral paracetamol versus oral ibuprofen for closure of patent ductus arteriosus in preterm infants: a randomized controlled trial. J Matern Fetal Neonatal Med 2019;32: 3647-54.
El-Mashad AE-R, El-Mahdy H, El Amrousy D, Elgendy M. Comparative study of the efficacy and safety of paracetamol, ibuprofen, and indomethacin in closure of patent ductus arteriosus in preterm neonates. Eur J Pediatr 2017;176:233-40.
Ohlsson A, Shah PS. Paracetamol (acetaminophen) for patent ductus arteriosus in preterm or low birth weight infants. Cochrane Database Syst Rev 2018;(4):CD010061.
Dathe K, Schaefer C. Drug safety in pregnancy: the German Embryotox Institute. Eur J Clin Pharmacol 2018;74:171-9.
Schaefer C, Ornoy A, Clementi M, Meister R, Weber-Schoendorfer C. Using observational cohort data for studying drug effects on pregnancy outcome-methodological considerations. Reprod Toxicol 2008;26:36-41.
Vandenbroucke JP, Von Elm E, Altman DG, Goetzsche PC, Mulrow CD, Pocock SJ, et al. Strengthening the reporting of observational studies in epidemiology (STROBE): explanation and elaboration. PLoS Med 2007;4:1628-54.
Beck E, Lechner A, Schaefer C. Who seeks Teratology Information Service's advice? Assessing the risk of selection bias in observational cohort studies on drug risks in pregnancy. Reprod Toxicol 2017;67:79-84.
Manchester D, Margolis HS, Sheldon RE. Possible association between maternal indomethacin therapy and primary pulmonary hypertension of the newborn. Am J Obstet Gynecol 1976;126:467-9.
Momma K, Takeuchi H. Constriction of fetal ductus arteriosus by non-steroidal anti-inflammatory drugs: study of additional 34 drugs. Prostaglandins 1983;26:631-43.
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Grant Information :
International German Federal Institute for Drugs and Medical Devices (BfArM)
Contributed Indexing :
Keywords: Closure of ductus arteriosus Botalli*; ductus arteriosus*; fetal renal impairment*; fetus*; oligohydramnios*; paracetamol (acetaminophen)*; persistent fetal circulation*; stillbirth*; third trimester of pregnancy*
Substance Nomenclature :
0 (Analgesics, Non-Narcotic)
362O9ITL9D (Acetaminophen)
Entry Date(s) :
Date Created: 20190717 Date Completed: 20191118 Latest Revision: 20200108
Update Code :
20200716
DOI :
10.1111/1471-0528.15872
PMID :
31310697
Czasopismo naukowe
Objective: Risk of fetotoxicity after paracetamol exposure in the third trimester.
Design: Observational cohort study and retrospective case assessment.
Setting: Germany, 2008-2017.
Population: Pregnant women exposed to paracetamol.
Methods: Prospectively enrolled third-trimester pregnancies that had been exposed to paracetamol (604) were compared with pregnancies exposed to paracetamol in the first and/or second trimester only (1192). Exclusion criteria were exposure to nonsteroidal anti-inflammatory drugs (NSAIDs) in the second or third trimester. Additionally, the Embryotox 'adverse drug reaction in pregnancy' database was screened for cases of fetotoxicity.
Main Outcome Measures: The prenatal study end points focused on narrowing or closure of ductus arteriosus Botalli, late fetal death, and oligohydramnios. The postnatal end points included patent ductus arteriosus (PDA), primary pulmonary hypertension (PPHT), and impaired renal function.
Results: In both cohorts, no fetus with intrauterine narrowing or closure of the ductus arteriosus Botalli was reported (0/604 versus 0/1192). Oligohydramnios was diagnosed at a similar frequency in both cohorts: 1.3% (8/604) versus 1.6% (19/1192). There was one stillbirth in the study cohort (1/604, 0.2%) and four stillbirths in the comparison cohort (4/1192, 0.3%). The rates of PDA in neonates were similar: 0.7% (4/615) versus 0.7% (9/1212). PPHT as well as serious postnatal renal disorders were reported once in each cohort. In 12 out of 96 retrospective cases, there were indicators for study end points; however, co-exposure to NSAIDs or complex situations weaken the assumption of paracetamol toxicity.
Conclusions: Fetal cardiovascular or renal toxicity of maternal third-trimester paracetamol use appears to be negligible.
Tweetable Abstract: Paracetamol use in the third trimester does not seem to be associated with a relevant risk of fetotoxicity.
(2019 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists.)
Comment in: BJOG. 2019 Dec;126(13):1568. (PMID: 31479565)

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