Pregnancy outcome following maternal exposure to pregabalin may call for concern

Neurology

Volumn 86, Issue 24, 2016, Pages 2251-2257

  Winterfeld, Ursula ^a   Merlob, Paul ^b   Baud, David ^a   Rousson, Valentin ^c   Panchaud, Alice ^a   Rothuizen, Laura E ^a   Bernard, Nathalie ^d   Vial, Thierry ^d   Yates, Laura M ^e   Pistelli, Alessandra ^f   Ellfolk, Maria ^g   Eleftheriou, Georgios ^h   De Vries, Loes C ^i,j   Jonville Bera, Annie Pierre ^k   Kadioglu, Mine ^l   Biollaz, Jerome ^a   Buclin, Thierry ^a  

^a LAUSANNE UNIVERSITY HOSPITAL   (Switzerland)

^b TEL AVIV UNIVERSITY   (Israel)

^c UNIVERSITY OF LAUSANNE   (Switzerland)

^d HOSPICES CIVILS DE LYON   (France)

^e NEWCASTLE UPON TYNE HOSPITALS NHS FOUNDATION TRUST   (United Kingdom)

^f CAREGGI UNIVERSITY HOSPITAL   (Italy)

^g HELSINKI UNIVERSITY CENTRAL HOSPITAL   (Finland)

^h Poison Control Center   (Italy)

ⁱ Netherlands Pharmacovigilance Centre Lareb   (Netherlands)

^j UNIVERSITY OF GRONINGEN   (Netherlands)

^k UNIVERSITY HOSPITAL OF TOURS   (France)

^l KARADENIZ TECHNICAL UNIVERSITY   (Turkey)

more..

Author keywords

[No Author keywords available]

Indexed keywords

PREGABALIN; CENTRAL NERVOUS SYSTEM AGENTS;

ADULT; ALCOHOL CONSUMPTION; ANXIETY DISORDER; ARTICLE; BIPOLAR DISORDER; CLAVICLE FRACTURE; COHORT ANALYSIS; COMPARATIVE STUDY; CONGENITAL MALFORMATION; CONTROLLED STUDY; DEPRESSION; DISEASE ASSESSMENT; EPILEPSY; FEMALE; FIRST TRIMESTER PREGNANCY; FOLLOW UP; GESTATIONAL AGE; HUMAN; KIDNEY FAILURE; LIVE BIRTH; MAJOR CLINICAL STUDY; MATERNAL AGE; MATERNAL EXPOSURE; METABOLIC ACIDOSIS; MULTICENTER STUDY; MUSCLE HYPOTONIA; NEUROPATHIC PAIN; OBSERVATIONAL STUDY; PREGNANCY OUTCOME; PREGNANCY TERMINATION; PREMATURE LABOR; PRENATAL DRUG EXPOSURE; PRIORITY JOURNAL; PROSPECTIVE STUDY; RESPIRATORY DISTRESS; RESTLESS LEGS SYNDROME; SHOCK; SPONTANEOUS ABORTION; TOBACCO USE; WITHDRAWAL SYNDROME; CLINICAL TRIAL; DRUG EFFECT; DRUG INDUCED MALFORMATION; DRUG SURVEILLANCE PROGRAM; EUROPE; INCIDENCE; PREGNANCY; PROPORTIONAL HAZARDS MODEL; RISK;

ABNORMALITIES, DRUG-INDUCED; ADULT; CENTRAL NERVOUS SYSTEM AGENTS; EUROPE; FEMALE; HUMANS; INCIDENCE; PHARMACOVIGILANCE; PREGABALIN; PREGNANCY; PREGNANCY OUTCOME; PREGNANCY TRIMESTER, FIRST; PROPORTIONAL HAZARDS MODELS; PROSPECTIVE STUDIES; RISK;

EID: 84974687836     PISSN: 00283878     EISSN: 1526632X     Source Type: Journal    
DOI: 10.1212/WNL.0000000000002767     Document Type: Article

References (24)

1. Pharmacology Review: Lyrica Pregabalin. Available at: http://www.accessdata.fda.gov/drugsatfda-docs/label/2006/021446s002, s003lbl.pdf. Accessed August 20, 2014
2. Tassone DM, Boyce E, Guyer J, Nuzum D. Pregabalin: a novel gamma-Aminobutyric acid analogue in the treatment of neuropathic pain, partial-onset seizures, and anxiety disorders. Clin Ther 2007; 29: 26-48
3. Schifano F, D'Offizi S, Piccione M, et al. Is there a recreational misuse potential for pregabalin' Analysis of anecdotal online reports in comparison with related gabapentin and clonazepam data. Psychother Psychosom 2011; 80: 118-122
4. Wettermark B, Brandt L, Kieler H, Boden R. Pregabalin is increasingly prescribed for neuropathic pain, generalised anxiety disorder and epilepsy but many patients discontinue treatment. Int J Clin Pract 2014; 68: 104-110
5. Reimers A. New antiepileptic drugs and women. Seizure 2014; 23: 585-591
6. van Hecke O, Torrance N, Smith BH. Chronic pain epidemiology and its clinical relevance. Br J Anaesth 2013; 111: 13-18
7. Kessler RC, Petukhova M, Sampson NA, Zaslavsky AM, Wittchen HU. Twelve-month and lifetime prevalence and lifetime morbid risk of anxiety and mood disorders in the United States. Int J Methods Psychiatr Res 2012; 21: 169-184
8. Etemad L, Mohammad A, Mohammadpour AH, Vahdati Mashhadi N, Moallem SA. Teratogenic effects of pregabalin in mice. Iran J Basic Med Sci 2013; 16: 1065-1070
9. Reprotox: Micromedex. Pregabalin. Available at: http://www.micromedexsolutions.com/. Accessed August 20, 2014
10. Centre for Drug Evaluation and Research Approval Package. Lyrica (Pregabalin): Pharmacology Review. Available at: http://www.accessdata.fda.gov/drugsatfda-docs/nda/2004/021446-Lyrica%20Capsules-pharmr.PDF. Accessed November 19, 2014
11. Veiby G, Daltveit AK, Engelsen BA, Gilhus NE. Fetal growth restriction and birth defects with newer and older antiepileptic drugs during pregnancy. J Neurol 2014; 261: 579-588
12. Fujii H, Goel A, Bernard N, et al. Pregnancy outcomes following gabapentin use: results of a prospective comparative cohort study. Neurology 2013; 80: 1565-1570
13. Winterfeld U, Klinger G, Panchaud A, et al. Pregnancy outcome following maternal exposure to mirtazapine: a multicenter, prospective study. J Clin Psychopharmacol Epub 2015 Mar 31
14. Winterfeld U, Allignol A, Panchaud A, et al. Pregnancy outcome following maternal exposure to statins: a multicentre prospective study. BJOG 2013; 120: 463-471
15. Weber-Schoendorfer C, Chambers C, Wacker E, et al. Pregnancy outcome after methotrexate treatment for rheumatic disease prior to or during early pregnancy: a prospective multicenter cohort study. Arthritis Rheumatol 2014; 66: 1101-1110
16. Merks JH, van Karnebeek CD, Caron HN, Hennekam RC. Phenotypic abnormalities: terminology and classification. Am J Med Genet A 2003; 123A: 211-230
17. Rasmussen SA, Olney RS, Holmes LB, et al. Guidelines for case classification for the National Birth Defects Prevention Study. Birth Defects Res A Clin Mol Teratol 2003; 67: 193-201
18. Andersen PK, Geskus RB, de Witte T, Putter H. Competing risks in epidemiology: possibilities and pitfalls. Int J Epidemiol 2012; 41: 861-870
19. Hauben M, Aronson JK. Defining signal and its subtypes in pharmacovigilance based on a systematic review of previous definitions. Drug Saf 2009; 32: 99-110
20. Grigoriadis S, VonderPorten EH, Mamisashvili L, et al. Antidepressant exposure during pregnancy and congenital malformations: is there an association' A systematic review and meta-Analysis of the best evidence. J Clin Psychiatry 2013; 74: e293-308
21. Kroon LA. Drug interactions with smoking. Am J Health Syst Pharm 2007; 64: 1917-1921
22. Jauniaux E, Burton GJ. Morphological and biological effects of maternal exposure to tobacco smoke on the fetoplacental unit. Early Hum Dev 2007; 83: 699-706
23. Lepigeon K, Van Mieghem T, Vasseur Maurer S, Giannoni E, Baud D. Gastroschisis: what should be told to parents Prenat Diagn 2014; 34: 316-326
24. 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