Dispensing of potentially teratogenic drugs before conception and during pregnancy: A population-based study

BJOG: An International Journal of Obstetrics and Gynaecology

Volumn 122, Issue 8, 2015, Pages 1119-1129

  Zomerdijk, I M ^a,b   Ruiter, R ^a   Houweling, L M A ^c   Herings, R M C ^c   Straus, S M J M ^a   Stricker, B H ^a,d  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b MEDICINES EVALUATION BOARD   (Netherlands)

^c PHARMO INSTITUTE FOR DRUG OUTCOMES RESEARCH   (Netherlands)

^d Inspectorate of Health Care   (Netherlands)

Author keywords

Drug safety; embryotoxic; maternal drug use; pregnancy; teratogens

Indexed keywords

DOXYCYCLINE; NORETHISTERONE; PAROXETINE; SIMVASTATIN; TERATOGENIC AGENT; TRIPTORELIN;

ADULT; ARTICLE; COHORT ANALYSIS; CONCEPTION; DRUG CLASSIFICATION; DRUG DISPENSING; DRUG EXPOSURE; DRUG SAFETY; DRUG USE; DUTCHMAN; FEMALE; GESTATION PERIOD; HUMAN; NETHERLANDS; PHARMACEUTICAL CARE; POPULATION RESEARCH; PREGNANCY; PREGNANT WOMAN; PRESCRIPTION; PRIORITY JOURNAL; CLINICAL PRACTICE; EPIDEMIOLOGY; STATISTICS AND NUMERICAL DATA; SUPPLY AND DISTRIBUTION; TIME;

ADULT; DOXYCYCLINE; DRUG PRESCRIPTIONS; FEMALE; HUMANS; NETHERLANDS; NORETHINDRONE; PAROXETINE; PHYSICIAN'S PRACTICE PATTERNS; PREGNANCY; SIMVASTATIN; TERATOGENS; TIME FACTORS; TRIPTORELIN PAMOATE;

EID: 84932103062     PISSN: 14700328     EISSN: 14710528     Source Type: Journal    
DOI: 10.1111/1471-0528.13128     Document Type: Article

References (43)

1. Daw JR, Hanley GE, Greyson DL, Morgan SG,. Prescription drug use during pregnancy in developed countries: a systematic review. Pharmacoepidemiol Drug Saf 2011; 20: 895-902.
2. Singh S, Sedgh G, Hussain R,. Unintended pregnancy: worldwide levels, trends, and outcomes. Stud Fam Plann 2010; 41: 241-50.
3. Buhimschi CS, Weiner CP,. Medications in pregnancy and lactation: part 1. Teratology. Obstet Gynecol 2009; 113: 166-88.
4. Ruiter R, Teichert M, Straus SM, Stricker BH, Visser LE,. Concomitant use of contraceptives and potentially teratogenic medicinal products-results from a study using pharmacy dispensing data in the Netherlands. Reprod Sci 2012; 19: 987-94.
5. Schwarz EB, Longo LS, Zhao X, Stone RA, Cunningham F, Good CB,. Provision of potentially teratogenic medications to female veterans of childbearing age. Med Care 2010; 48: 834-42.
6. Schwarz EB, Postlethwaite DA, Hung YY, Armstrong MA,. Documentation of contraception and pregnancy when prescribing potentially teratogenic medications for reproductive-age women. Ann Intern Med 2007; 147: 370-6.
7. Andrade SE, Raebel MA, Morse AN, Davis RL, Chan KA, Finkelstein JA, et al., Use of prescription medications with a potential for fetal harm among pregnant women. Pharmacoepidemiol Drug Saf 2006; 15: 546-54.
8. Andrade SE, Gurwitz JH, Davis RL, Chan KA, Finkelstein JA, Fortman K, et al., Prescription drug use in pregnancy. Am J Obstet Gynecol 2004; 191: 398-407.
9. Wen SW, Yang T, Krewski D, Yang Q, Nimrod C, Garner P, et al., Patterns of pregnancy exposure to prescription FDA C, D and X drugs in a Canadian population. J Perinatol 2008; 28: 324-9.
10. Kulaga S, Zargarzadeh AH, Berard A,. Prescriptions filled during pregnancy for drugs with the potential of fetal harm. BJOG 2009; 116: 1788-95.
11. Cleary BJ, Butt H, Strawbridge JD, Gallagher PJ, Fahey T, Murphy DJ,. Medication use in early pregnancy-prevalence and determinants of use in a prospective cohort of women. Pharmacoepidemiol Drug Saf 2010; 19: 408-17.
12. Bakker MK, Jentink J, Vroom F, Van Den Berg PB, De Walle HE, De Jong-Van Den Berg LT,. Drug prescription patterns before, during and after pregnancy for chronic, occasional and pregnancy-related drugs in the Netherlands. BJOG 2006; 113: 559-68.
13. Herings RM, Bakker A, Stricker BH, Nap G,. Pharmaco-morbidity linkage: a feasibility study comparing morbidity in two pharmacy based exposure cohorts. J Epidemiol Community Health 1992; 46: 136-40.
14. WHO Collaborating Centre for Drug Statistics Methodology. Anatomical Therapeutic Chemical (ATC) index with Defined Daily Doses (DDDs). [ www.whocc.no/atc-ddd-index/ ]. Accessed 4 October 2013.
15. Stichting Perinatale Registratie Nederland. Grote Lijnen 10 Jaar Perinatale Registratie Nederland. Utrecht: Stichting Perinatale Registratie Nederland, 2011.
16. Houweling LM, Bezemer ID, Penning-van Beest FJ, Meijer WM, van Lingen RA, Herings RM,. First year of life medication use and hospital admission rates: premature compared with term infants. J Pediatr 2013; 163: 61-66.e1.
17. Briggs GG, Freeman RK, Yaffe SJ,. Drugs in pregnancy and lactation, 4th edn. Baltimore: Williams & Wilkins; 1994.
18. Australian Drug Evaluation Committee. Medicines in Pregnancy. An Australian Categorization of Risk. Australian Drug Evaluation Committee, 1992.
19. FASS. Classification of Medical Products for Use During Pregnancy and Lactation. The Swedish System. Stockholm: LINFO, Drug Information Ltd., 1993.
20. Addis A, Sharabi S, Bonati M,. Risk classification systems for drug use during pregnancy: are they a reliable source of information? Drug Saf 2000; 23: 245-53.
21. Mitchell AA, Gilboa SM, Werler MM, Kelley KE, Louik C, Hernandez-Diaz S,. Medication use during pregnancy, with particular focus on prescription drugs: 1976-2008. Am J Obstet Gynecol 2011; 205: 51.e1-8.
22. van Gelder MM, van Rooij IA, Miller RK, Zielhuis GA, de Jong-van den Berg LT, Roeleveld N,. Teratogenic mechanisms of medical drugs. Hum Reprod Update 2010; 16: 378-94.
23. Sannerstedt R, Lundborg P, Danielsson BR, Kihlstrom I, Alvan G, Prame B, et al., Drugs during pregnancy: an issue of risk classification and information to prescribers. Drug Saf 1996; 14: 69-77.
24. Daw JR, Mintzes B, Law MR, Hanley GE, Morgan SG,. Prescription drug use in pregnancy: a retrospective, population-based study in British Columbia, Canada (2001-2006). Clin Ther 2012; 34: 239.e2-249.e2.
25. van Gelder MM, Bos JH, Roeleveld N, de Jong-van den Berg LT,. Drugs associated with teratogenic mechanisms. Part I: dispensing rates among pregnant women in the Netherlands, 1998-2009. Hum Reprod 2014; 29: 161-7.
26. Santos F, Oraichi D, Berard A,. Prevalence and predictors of anti-infective use during pregnancy. Pharmacoepidemiol Drug Saf 2010; 19: 418-27.
27. Koren G, Pastuszak A, Ito S,. Drugs in pregnancy. N Engl J Med 1998; 338: 1128-37.
28. College ter Beoordeling van Geneesmiddelen (CBG). Dear Healthcare Professional Communication Paroxetine. [ www.cbg-meb.nl/NR/rdonlyres/2C45EEB4-BDD7-469B-9C5C-015DFB4B3196/0/ddseroxatapoth.pdf ]. Accessed 5 December 2013.
29. Bakker MK, Kerstjens-Frederikse WS, Buys CH, de Walle HE, de Jong-van den Berg LT,. First-trimester use of paroxetine and congenital heart defects: a population-based case-control study. Birth Defects Res A Clin Mol Teratol 2010; 88: 94-100.
30. Cole JA, Ephross SA, Cosmatos IS, Walker AM,. Paroxetine in the first trimester and the prevalence of congenital malformations. Pharmacoepidemiol Drug Saf 2007; 16: 1075-85.
31. Berard A, Ramos E, Rey E, Blais L, St-Andre M, Oraichi D,. First trimester exposure to paroxetine and risk of cardiac malformations in infants: the importance of dosage. Birth Defects Res B Dev Reprod Toxicol 2007; 80: 18-27.
32. Alwan S, Reefhuis J, Rasmussen SA, Olney RS, Friedman JM,. Use of selective serotonin-reuptake inhibitors in pregnancy and the risk of birth defects. N Engl J Med 2007; 356: 2684-92.
33. Louik C, Lin AE, Werler MM, Hernandez-Diaz S, Mitchell AA,. First-trimester use of selective serotonin-reuptake inhibitors and the risk of birth defects. N Engl J Med 2007; 356: 2675-83.
34. Jimenez-Solem E, Andersen JT, Petersen M, Broedbaek K, Jensen JK, Afzal S, et al., Exposure to selective serotonin reuptake inhibitors and the risk of congenital malformations: a nationwide cohort study. BMJ Open 2012; 2. pii: e001148. doi: 10.1136/bmjopen-2012-001148.
35. Margulis AV, Abou-Ali A, Strazzeri MM, Ding Y, Kuyateh F, Frimpong EY, et al., Use of selective serotonin reuptake inhibitors in pregnancy and cardiac malformations: a propensity-score matched cohort in CPRD. Pharmacoepidemiol Drug Saf 2013; 22: 942-51.
36. Pedersen LH, Henriksen TB, Vestergaard M, Olsen J, Bech BH,. Selective serotonin reuptake inhibitors in pregnancy and congenital malformations: population based cohort study. BMJ 2009; 339: b3569.
37. Kusters DM, Lahsinoui HH, van de Post JA, Wiegman A, Wijburg FA, Kastelein JJ, et al., Statin use during pregnancy: a systematic review and meta-analysis. Expert Rev Cardiovasc Ther 2012; 10: 363-78.
38. Berard A, Azoulay L, Koren G, Blais L, Perreault S, Oraichi D,. Isotretinoin, pregnancies, abortions and birth defects: a population-based perspective. Br J Clin Pharmacol 2007; 63: 196-205.
39. Bensouda-Grimaldi L, Jonville-Bera AP, Mouret E, Elefant E, Dhellot H, Delmas C, et al., Isotretinoin: compliance with recommendations in childbearing women. Ann Dermatol Venereol 2005; 132: 415-23.
40. Crijns HJ, Straus SM, Gispen-de Wied C, de Jong-van den Berg LT,. Compliance with pregnancy prevention programmes of isotretinoin in Europe: a systematic review. Br J Dermatol 2011; 164: 238-44.
41. Shin J, Cheetham TC, Wong L, Niu F, Kass E, Yoshinaga MA, et al., The impact of the iPLEDGE program on isotretinoin fetal exposure in an integrated health care system. J Am Acad Dermatol 2011; 65: 1117-25.
42. Brinker A, Kornegay C, Nourjah P,. Trends in adherence to a revised risk management program designed to decrease or eliminate isotretinoin-exposed pregnancies: evaluation of the accutane SMART program. Arch Dermatol 2005; 141: 563-9.
43. Teichert M, Visser LE, Dufour M, Rodenburg E, Straus SM, De Smet PA, et al., Isotretinoin use and compliance with the Dutch Pregnancy Prevention Programme: a retrospective cohort study in females of reproductive age using pharmacy dispensing data. Drug Saf 2010; 33: 315-26.