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Medication Safety in Pregnancy

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Publications 

 


2018

 

Metformin exposure in first trimester of pregnancy and risk of all or specific congenital anomalies: exploratory case-control study.  Given JE, Loane M, Garne E, Addor MC, Bakker M, Bertaut-Nativel B, Gatt M, Klungsoyr K, Lelong N, Morgan M, Neville AJ, Pierini A, Rissmann A, Dolk H. BMJ 2018;361:k2477

 


The preconception care experiences of women with epilepsy on sodium valproate.

Lawther L, Dolk H, Sinclair M, Morrow J.

Seizure. 2018 May 16;59:82-89. doi: 10.1016/j.seizure.2018.05.003. [Epub ahead of print]


Prevalence of valproate syndrome in Europe from 2005 to 2014: A registry based multi-centre study.

Morris JK, Garne E, Loane M, Addor MC, Barisic I, Bianchi F, Gatt M, Lanzoni M, Lynch C, Mokoroa O, Nelen V, Neville A, O'Mahony MT, Randrianaivo-Ranjatoelina H, Rissmann A, Tucker D, de Walle HEK, Zymak-Zakutnia N, Rankin J.

Eur J Med Genet. 2018 May 18. pii: S1769-7212(18)30170-8. doi: 10.1016/j.ejmg.2018.05.008. [Epub ahead of print]


 

Insulin analogues use in pregnancy among women with pregestational diabetes mellitus and risk of congenital anomaly: a retrospective population-based cohort study. Wang, H, Wender-Ozegowska E, Garne E, Morgan M, Loane M, Bakker MK, Gatt M, de Walle H, Jordan S, Materna-Kiryluk A, Nelen V, Thys G, Wiesel A, Dolk H and de Jong-van den Berg LTW.



2017
Cavero-Carbonell C, Vinkel-Hansen A, Rabanque-Hernandez MJ, Martos C, Garne E (2017).  Fetal exposure to Montelukast and congenital anomalies: A population based study in Denmark.  Birth Defects Research 109: 452-459.  (
Full text).

 

EUROmediCAT (2017), EUROmediCAT Sources of Information on Medication Use in Pregnancy (updated December 2017) (Full text)

Given JE, Loane M, Garne E, Nelen V, Barisic I, Randrianaivo H, Khoshnood B, Wiesel A, Rissmann A, Lynch C, Neville AJ, Pierini A, Bakker M, Klungsoyr K, Latos Bielenska A, et al. (2017). “Gastroschisis in Europe - A Case-malformed-Control Study of Medication and Maternal Illness during Pregnancy as Risk Factors”. Paediatric and Perinatal Epidemiology. Available at:
http://doi.wiley.com/10.1111/ppe.12401.

 

Given JE, Loane M, Garne E, Nelen V, Barisic I, Randrianaivo H, Khoshnood B, Wiesel A, Rissmann A, Lynch C, Neville AJ, Pierini A, Bakker M, Klungsoyr K, Bielenska AL, et al. (2017). “Gastroschisis in Europe – A prevalence and case-malformed control study”. Reproductive Toxicology, 72(2017), p.23. Available at: http://linkinghub.elsevier.com/retrieve/pii/S0890623817303507

Sinclair M, Lagan BM, Dolk H, McCullough JEM (2017). “As assessment of pregnant women’s knowledge and use of the internet for medication safety information and purchase”. Journal of Advanced Nursing, DOI: 10.1111/jan.13387.
 

2016

Boyle B, Garne E, Loane M, Addor M-C, Arriola L, Cavero-Carbonell C, de Walle H, Gatt M, Lelong N, Lynch C, Nelen V, Neville AJ, O'Mahony M, Pierini A, Rissmann A, Tuckers D, Zymak-Zakutnia N, Dolk H (2016).  The changing epidemiology of Ebstein's anomaly and its relationship to maternal mental health conditions: a European registry-based study.  Cardiology in the Young. DOI:10.1017/S1047951116001025 (Full text)

Charlton RA, Klungsoyr K, Neville AJ, Jordan S, Pierini A, de Jong-van den Berg LTW, Bos J, Puccini A, Engeland A, Gini R, Davies G, Thayer D, Hansen AV, Morgan M, Wang H, McGrogan A, Nybo Andersen A-M, Dolk H, Garne E (2016).  Prescribing Antidiabetic Medicines before, during and after Pregnancy: A Study in Seven European Regions.  PLoS ONE 11(5): e0155737.  DOI: 10.1371/journal/pone.0155737.  (Full text)
 

Charlton RA, Pierini A, Klungsoyr K, Neville AJ, Jordan S, de Jong-van den Berg LTW, Thayer D, Bos HJ, Puccini A, Hansen AV, Gini R, Engeland A, Nybo Andersen A-M, Dolk H and Garne E  (2016).  Asthma medcation prescribing before, during and after pregnancy: a study in seven European regions.  BMJ Open 6.  DOI: 10.1136/bmjopen-2015-009237. (Full text)

de Jong J, Garne E, de Jong-van den Berg, Wang H (2016).  The risk of specific congenital anomalies in relation to newer antiepileptic drugs: A literature review.  Drugs-Real World Outcomes 3(2): 131-143. DOI 10.1007/s40801-016-0078-1. (Full text

 

EUROmediCAT (2016).  EUROmediCAT WP5: SSRI Population Linakage Protocol. EUROmediCAT Co-ordinating Centre, Ulster University. (Full text)

Garne E, Vinkel Hansen A, Morris J, Jordan S, Klungsoyr K, Engeland A, Tucker D, Thayer DS, Davies GI, Nybo-Andersen A-M, Dolk H (2016).  Risk of congenital anomalies after exposure to asthma medication in the first trimester of pregnancy - a cohort linkage study.  BJOG 123: 1609-1618.  DOI 10.1111/1471-0528.14026.  (Full text)

Given JE, Loane M, Luteijn JM, Morris JM, de Jong-van den Berg LTW, Garne E, Addor, M-C, Barisic I, de Walle H, Gatt M, Klungsoyr K, Khoshnood B, Latos-Bielenska A, Neville AJ, O'Mahony M, Pierini A, Tucker D, Wiesel A, Dolk H (2016).  EUROmediCAT signal detection: an evaluation of selected congenital anomaly-medication associations.  British Journal of Clinical Pharmacology.  DOI: 10.1111/bcp.12947.  (Abstract)

Jordan S, Morris JK, Davies GI, Tucker D, Thayer DS, Luteijn JM, Morgan M, Garne E, Hansen AV, Klungsoyr K, Engeland A, Boyle B, Dolk H (2016).  Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants in Pregnancy and Congenital Anomalies: analysis of linked databases in Wales, Norway and Funen, Denmark.  Plos One 11(12), DOI 10.1371/journal/pone.0165133.  (Full text)

Jordan S (2016).  The Impact of Asthma on congenital Anomalies, Prematurity, Birth Centiles and Infant Feeding: Retrospective Population Cohort Analysis 2004-2010.  International Population Data Linkage Conference 2016, 24-26 August 2016, Swansea, UK.

Luteijn J, Morris J, Garne E, Given J, de Jong-van den Berg L, Addor M-C, Bakker M, Barisic I, Gatt M, Klungsoyr K, Latos-Bielenska A, Lelong N, Nelen V, Neville A, O'Mahony M, Pierini A, Tucker D, de Walle H, Wiesel ALoane M, Dolk H (2016).  EUROmediCAT signal detection: a systematic method for identifying potential teratogenic medication.  British Journal of Clinical Pharmacology DOI:10.1111/bcp.13056. (Full text)

Morris J, Rankin J, Garne E, Loane M, Greenlees R, Addor M-C, Arriola L, Barisic I, Bergman JEH, Csaky-Szunyogh M, Dias C, Draper E, Gatt M, Khoshnood B, Klungsoyr K, Kurinczuk J, Lynch C, McDonnell R, Nelen V, Neville A, O'Mahony M, Pierini A, Randrianaivo H, Rissmann A, Tucker D, verellun-Dumoulin C, de Walle H, Wellesley D, Wiesel A, Dolk H (2016).  Prevalence of Microcephaly in Europe: a population based study.  BMJ 354:i4721, DOI: 10.1136/bmj.i4721.

Pierini A (2016).  The EUROmediCAT Project for Safety Evalation of Medications during Pregnancy.  Primary and Secondary Prevention of Rare Diseases: State of the Art and Future Perspectives, 11 April 2016, Italy.  (Presentation)

 

Pierini A, Coi A, Gini R, Bortolus R (2016).  Pharmacovigilance and reproductive health: the Italian contribute to the results of the EUROmediCAT project.  Pharmaco-vigilance.eu (Full text)

Plauborg A, Hansen A, Garne E (2016).  Use of Azathioprine and Corticosteroids during Pregnancy and Birth Outcome in Women Diagnosed with Inflammatory Bowel Disease.  Birth Defects Research (Part A) 106:494-499. DOI: 10.1002/bdra.23509.  (Full text) 

Schurman L, Vinkel Hansen, A, Garne E (2016).  Pregnancy outcomes after fetal exposure to antithyroid medications or levothyroxine. Early Human Development 101:73-77.  (Full text) 

 


2015

Boyle B, Garne E, Loane M, Addor M-C, Arriola L, Cavero-Carbonell C, de Walle HEK, Gatt M, Lelong N, Lynch C, Nelen V, Neville AJ, O'Mahony M, Pierini A, Rissmann A, Tucker D, Zymak-Zakutnia N and Dolk H (2015).  The epidemiology of Ebstein's anomaly in Europe: a registry-based study with special emphasis on medication exposure.  International Conferece on Pharmacoepidemiology & Therapeutic Risk Management, 22-26 August 2015, Boston, USA.  (Poster).

Boyle B, Loane M, Bakker M, Addor M-C, Arriola L, Garne E, Gatt M, Jordan S, Khoshnood B, Klungsoyr K, Nelen V, Neville A, O'Mahony M, Pierini A, Rissmann A, Tucker D, Wiesel A and Dolk H (2015).  Selective Serotonin Reuptake Inhibitor Use in First Trimester of Pregnancy and risk of Congenital Anomalies: a EUROmediCAT case-malformed control study in 12 countries.  International Conferece on Pharmacoepidemiology & Therapeutic Risk Management, 22-26 August 2015, Boston, USA.  (Poster)

Charlton R, Garne E, Wang H, Klungsoyr K, Jordan S, Neville A, Pierini A, Hansen A, Engeland A, Gini R, Thayer D, Bos J, Puccini A, Nybo Andersen A-M, Dolk H and de Jong van-den Berg L (2015).  Antiepileptic drug prescribing before, during and after pregnancy: a study in seven European regions.  Pharmacoepidemiology and Drug Safety, 24, 1144-1154.  DOI: 10.1002/pds.3847 (Full text)

Charlton R, Pierini A, Klungsoyr K, Neville AJ, Jordan S, de Jong-van den Berg LTW, Thayer D, Bos HJ, Puccini A, Hansen AV, Gini R, Engeland A, Nybo Andersen AM, Dolk H and Garne E (2015).  Asthma medication prescribing before, during and after pregnancy: a study in 7 European regions.   International Conferece on Pharmacoepidemiology & Therapeutic Risk Management, 22-26 August 2015, Boston, USA.  (Poster


de Jong L, Garne E, Gini R, Jordan SE, Klungsoyr K, Loane M, Neville AJ, Pierini A, Puccini A, Thayer DS, Tucker D, Vinkel Hansen A, Bakker MK (2015).  Improving information on maternal medication use by linking prescription data to congenital anomaly registers: A EUROmediCAT Study, Drug Safety.  DOI: 10.1007/s40264-015-0321-9 (Full text)

de Jong L, de Walle HEK, de Jong-van den Berg LTW, van Langen IM, Bakker MK (2015).  Actual use of medications prescribed during pregnancy: A cross-sectional study using data from a population-based congenital anomaly registry.  Drug Safety, DOI: 10.1007s40264-015-0302-z (Full text)

de Jong J, Garne E, Wender-Ozegowska E, Morgan M, de Jong-van den Berg LTW, Wang H (2015). Insulin analogues in pregnancy and specific congenital anomalies: a literature review.  Diabetes/Metabolism Research and Reviews, DOI: 10.1002/dmrr.2730 (Full text

Dolk H, de Jong-van den Berg LTW, Pierini A, Morris J, Bakker M, Jordan S, Garne E, Klungsoyr K, Loane M, Charlton R, Luteijn JM, Sinclair M, Latos-Bielenska A (2015).  EUROmediCAT Recommendations for European Pharmacovigilance Concerning Safety of Medication use in Pregnancy.  Pharmacoepidemiology & Drug Safety 24(S2): 3-7.  DOI: 10.1002/pds.3865 (Full text)

EUROmediCAT (2015). Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants in Pregnancy and Congenital Anomalies: population cohort study using linked electronic data in 3 countries V2. Deliverable 21.  EUROmediCAT Central Registry, ISBN 978-0956746252.  (Full text).
 

EUROmediCAT (2015).  Drug Safety During Pregnancy: EUROmediCAT Special Edition, Science, Technology and Innovation Projects, Insights Publishers (Full text)

Garne E, Vinkel Hansen A, Morris J, Zaupper L, Addor M-C, Barisic I, Gatt M, Lelong N, Klungsoyr K, O'Mahony M, Nelen V, Neville A, Pierini A, Tucker D, de Walle H, Wiesel A, Loane M and Dolk H (2015).  Use of asthma-medication during pregnancy and risk of specific congenital anomalies - A European case-malformed control study.  Journal of Allergy and Clinical Immunology, DOI:10.1016/j.jaci.2015.05.043 (Full text).

Garne E, A Vinkel Hansen, J Morris, S Jordan, K Klungsøyr, A Engeland, D Tucker, DS Thayer, GI Davies, A‐M Nybo Andersen, H Dolk (2015). Risk of congenital anomaly in relation to antiasthmatic use: Population Cohort linkage Study.  BJOG 123:1609–1618 DOI: 10.1111/1471-0528.14026 (Full text).

Garne E (2015).  Risk of congenital anomalies after exposure to asthma medication in the first trimester of pregnancy - a cohort linkage study.  Abstract accepted at 12th World Congress of Perinatal medicine, Madrid, Spain, 3-6 November 2015.

Jordan S (2015).  Mood disorders in pregnancy and prescription medicines. Arch Womens Ment Health 18 (2): 269–408(p366) DOI: 10.1007/S00737-014-0488-6. (Abstract)

 

Jordan S, Charlton  RA, Tingay K, Thayer DS,  Davies GI, Morgan M, Tucker D, Watkins A, Gini R, Pierini A, Hansen A, Garne E, Nybo Andersen A, Puccini A, Neville AJ, Bos HJ, de Jong-van den Berg LTW, de Vries CS, Dolk H (2015).  SSRI use in pregnancy: a study in 6 European databases. Arch Womens Ment Health 18 (2): 269–408(p368) DOI: 10.1007/S00737-014-0488-6. (Abstract)

Jordan S for the EUROmediCAT group (2015).  EUROmediCAT Safety of Drugs in Pregnancy. Arch Womens Ment Health 18 (2): 269–408(p337).  DOI: 10.1007/S00737-014-0488-6. (Abstract)


Luteijn JM, Addor M-C, Arriola L, Bianchi F, Garne E, Khoshnood B, Nelen V, Neville A, Queisser-Luft A, Rankin J, Rounding C, Verellen-Dumoulin C, de Walle H, Wellesley D, Wreyford B, Yevtushok L, de Jong-van den Berg L, Morris J and Dolk H (2015).  The effect of H1N1 pandemic influenza on congenital anomaly prevalence in Europe: an ecological time series study. Epidemiology 26(6): 853-861 (Abstract).

 

Wemakor A, Casson K, Garne E, Bakker M, Addor M-C, Arriola L, Gatt M, Khoshnood B, Klungsoyr K, Nelen V, O'Mahony M, Pierini A, Rissmann A, Tucker D, Boyle B, de Jong-van den Berg L, Dolk H (2015).  Selective serotonin reuptake inhibitor antidepressant use in first trimester pregnancy and risk of specific congenital anomalies: A European register-based study.  Eur J Epidemiol DOI: 10.1007/s10654-015-0065-y (Full text)


 

2014

Charlton R, Jordan S, Pierini A, Garne E, Neville A, Hansen A, Gini R, Thayer D, Tingay K, Puccini A, Bos H, Nybo Andersen A, Sinclair M, Dolk H, de Jong-van den Berg L (2014).  Selective serotonin reuptake inhibitor prescribing before, during and after pregnancy: a population-based study in six European regions. BJOG 23 (6): 1010-1020.  DOI: 10.1111/1471-0528.13143 (Full Text)

 

Charlton R, Neville A, Jordan S, Pierini A, Damase-Michel C, Klungsøyr K, Nybo Anderson A-M, Vinkel Hansen A, Gini R, Bos J, Puccini A, Hurault-Delarue C, Brooks C, de Jong-van den Berg L and de Vries C (2014).  Healthcare databases in Europe for studying medicine use and safety during pregnancy.  Pharmacoepidemiology and Drug Safety, 23 (6): 586-594.  DOI: 10.1002/pds.3613  (Full Text)

 

Charlton R, Garne E, Wang H, Klungsoyr K, Jordan S, Neville A, Pierini A, Vinkel Hansen A, Engeland A, Gini R, Thayer D, Tingay K, Bos HJ, Pucini A, Nybo Andersen A-M, Dolk H, de Jong-van den Berg LTW (2014). Antiepileptic drug use before, during and after pregnancy: A study in 7 European regions. Pharmacoepidemiology and Drug Safety 23 (S1): 22-23.  DOI:10.1002/pds.3701  (Abstract

EUROCAT (2014).  Special Report: Sources of Information on Medication Use in Pregnancy.  EUROCAT Central Registry, University of Ulster (Full text

 

Knudsen T, Vinkel-Hansen A, Garne E, Nybo-Andersen A-M (2014).  Increased risk of severe congenital heart defects in offspring exposed to selective serotonin-reuptake inhibitors in early pregnancy - an epidemiological study using validated EUROCAT data.  BMC Pregnancy and Childbirth, 14(1): 2-8.  DOI: 10.1186/1471-2393-14-333 (Full text)

 

Lagan B, Dolk H, White B, Uges D and Sinclair M (2014).  Assessing the availability of the teratogenic drug isotretinoin outside the pregnancy prevention programme: a survey of e-pharmacies.  Pharmacoepidemiology and Drug Safety, 23 (4): 411-418. DOI: 10.1002/pds.3565  (Full Text)

 

Sinclair, M (2014).  Over-the-counter pain medication in pregnancy. Evidence based midwifery, 12 (3): 75.  (Full text)

 

  

 

2013 

White B, Lagan B and Sinclair M (2013).  Purchasing medicines online: a study of isotretinoin.  International Pharmaceutical Federation Congress, 4 September, Dublin.  (Poster)

 

 
 

2012

Dolk H, de Jong-van den Berg L, Loane M, Wang, H and Morris J (2012).  Newer anticonvulsants: Lamotrigine.  Birth Defects Research Part A Clinical and Molecular Teratology, 94: 959.  (Letter)


Dolk H, Smith K, Garne E, Stemann Larsen P, Nybo Andersen A-M (2012). CHICOS-EUROmediCAT Collaboration, Stage 1 Report, Survey of European Birth Cohorts (Full text)

 

Lagan BM, Dolk H, Sinclair M, White B (2012).  Online purchasing of Isotretinoin: E-pharmacies provision of safety information (Abstract No 822). Pharmacoepidemiology and Drug Safety , 21 (Suppl 3): 1–481(p381).  Poster ISPE Conference August 2012

 

Marsh B (2012).  Are asthma inhalers linked to birth defects?  Thousands of pregnant women at centre of inquiry into health problems in babies.  Daily Mail, 11 March.  (Full text)

 

 
 

2011 

Bakker M (2011).  Medicijngebruik tijdens zwangerschap, het belang van postmarketing surveillance. [In Dutch] Medicine use during pregnancy, the importance of post marketing surveillance.   MFM-Tijdschrift, 6th Edition.  (Full Text)

 

Blienkendaal M (2011).  Slikken op goed geluk. [In Dutch]  Taking your chances with drugs.  C2W Medicines, March.  (Full Text)

 

de Jong-van den Berg LTW (2011).  Geneesmiddelen en zwangerschap.  [In Dutch] Drugs and pregnancy.  Tijdschrift voor Verloskunde, 36, 33-36. (Abstract)

 

de Jong-van den Berg LTW (2011).  Ook zwangere verdient juiste medicatiezorg. [In Dutch] Pregnant women also deserve correct medication care.  Pharmaceutisch Weekblad, 146: 17-19.

  

de Jong-van den Berg LTW, Bakker MK and Dolk H (2011).  EUROmediCAT: European Surveillance of Safety of Medication Use in Pregnancy.  Pharmacoepidemiology and Drug Safety, 20: S46-S47.  DOI: 10.1002/pds (Abstract)

 

Dolk H, Bakker M and de Jong-van den Berg L (2011).  EUROmediCAT: Safety of medication use in pregnancy.  International Conference PharmacoEpidemiology, 14-17 August, Chicago.  (Poster)

 

Morgan M, de Jong-Van den Berg LTW and Jordan S (2011).  Drug safety in pregnancy – monitoring congenital anomalies. Journal of Nursing Management, 19 (3): 305–310.  DOI: 10.1111/j.1365-2834.2011.01250.x (Full Text)

 
 

 

2010

Jentink J, Dolk H, Loane M, Morris J, Wellesley D, Garne E, de Jong-van den Berg L and EUROCAT Antiepileptic Study Working Group (2010).  Intrauterine exposure to carbamazepine and specific congenital malformations: systematic review and case-control study. British Medical Journal, 341: C6581.  DOI:10.1136/bmj.c6581  (Full Text)

 

Jentink J, Loane M, Dolk H, Barisic I, Garne E, Morris J, de Jong-van den Berg L and EUROCAT Antiepileptic Study Working Group (2010). Valproic acid monotherapy in pregnancy and major congenital malformations. The New England Journal of Medicine. 362(23): 2185-2193. (Full Text)

 
 

 

2008

Dolk H, Jentink J, Loane M, Morris J, de Jong-van den Berg L and EUROCAT Antiepileptic Drug Working Group (2008). Does Lamotrigine use in pregnancy increase orofacial cleft risk relative to other malformations. Neurology, 71: 714-722. DOI: 10.1212/01.wnl.0000316194.98475.d8 (Abstract)