Isotretinoin exposure during pregnancy: A population-based study in the Netherlands

BMJ Open

Volumn 4, Issue 11, 2014, Pages

  Zomerdijk, Ingeborg M ^a,b   Ruiter, Rikje ^a,c   Houweling, Leanne M A ^d   Herings, Ron M C ^d   Sturkenboom, Miriam C J M ^a   Straus, Sabine M J M ^a,b   Stricker, Bruno H ^a,e  

^a ERASMUS MEDICAL CENTER   (Netherlands)

^b MEDICINES EVALUATION BOARD   (Netherlands)

^c GROENE HART HOSPITAL   (Netherlands)

^d PHARMO INSTITUTE FOR DRUG OUTCOMES RESEARCH   (Netherlands)

^e Drug Safety Unit   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ISOTRETINOIN; DERMATOLOGICAL AGENT;

ADULT; ADVERSE OUTCOME; ARTICLE; COHORT ANALYSIS; ENVIRONMENTAL EXPOSURE; FEMALE; FETUS DEATH; FETUS OUTCOME; GESTATION PERIOD; HUMAN; MAJOR CLINICAL STUDY; MALE; MATERNAL AGE; NETHERLANDS; NEWBORN; OUTCOME ASSESSMENT; PREGNANCY; PREGNANCY OUTCOME; PREGNANT WOMAN; PRENATAL DRUG EXPOSURE; ABNORMALITIES, DRUG-INDUCED; YOUNG ADULT;

ABNORMALITIES, DRUG-INDUCED; ADULT; DERMATOLOGIC AGENTS; FEMALE; FETAL DEATH; HUMANS; INFANT, NEWBORN; ISOTRETINOIN; NETHERLANDS; PREGNANCY; YOUNG ADULT;

EID: 84911946747     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2014-005602     Document Type: Article

References (28)

1. European Medicines Agency (EMA). Annex I of the Summary information on a referral opinion following an arbitration pursant to article 29 of directive 2001/83/EC for isotretinoin. 2003. http://www.ema.europa.eu/docs/en-GB/document-library/Referrals-document/Isotretinoin-29/WC500010881.pdf (accessed 2 May 2013).
2. Rosa FW. Teratogenicity of isotretinoin. Lancet 1983;2:513.
3. Lammer EJ, Chen DT, Hoar RM, et al. Retinoic acid embryopathy. N Engl J Med 1985;313:837-41.
4. Abroms L, Maibach E, Lyon-Daniel K, et al. What is the best approach to reducing birth defects associated with isotretinoin? PLoS Med 2006;3:e483.
5. Schaefer C, Meister R, Weber-Schoendorfer C. Isotretinoin exposure and pregnancy outcome: an observational study of the Berlin Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy. Arch Gynecol Obstet 2010;281:221-7.
6. Autret-Leca E, Kreft-Jais C, Elefant E, et al. Isotretinoin exposure during pregnancy: assessment of spontaneous reports in France. Drug Saf 2010;33:659-65.
7. Crijns I, Straus S, Luteijn M, et al. Implementation of the harmonized EU isotretinoin Pregnancy Prevention Programme: a questionnaire survey among European regulatory agencies. Drug Saf 2012;35:27-32.
8. Teichert M, Visser LE, Dufour M, 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.
9. Crijns HJ, van Rein N, Gispen-de Wied CC, et al. Prescriptive contraceptive use among isotretinoin users in the Netherlands in comparison with non-users: a drug utilisation study. Pharmacoepidemiol Drug Saf 2012;21:1060-6.
10. Herings RM, Bakker A, Stricker BH, et al. Pharmaco-morbidity linkage: a feasibility study comparing morbidity in two pharmacy based exposure cohorts. J Epidemiol Community Health 1992;46:136-40.
11. WHO Collaborating Centre for Drug Statistics Methodology. Anatomical Therapeutic Chemical (ATC) index with Defined Daily Doses (DDDs). http://www.whocc.no/atc-ddd-index/(accessed 4 Oct 2013).
12. Stichting Perinatale Registratie Nederland. Grote Lijnen 10 jaar Perinatale Registratie Nederland. Utrecht: Stichting Perinatale Registratie Nederland, 2011.
13. Houweling LM, Bezemer ID, Penning-van Beest FJ, et al. First year of life medication use and hospital admission rates: premature compared with term infants. J Pediatr 2013;163:61-6.e1.
14. Crijns I, Mantel-Teeuwisse A, Bloemberg R, et al. Healthcare professional surveys to investigate the implementation of the isotretinoin Pregnancy Prevention Programme: a descriptive study. Expert Opin Drug Saf 2013;12:29-38.
15. Berard A, Azoulay L, Koren G, et al. Isotretinoin, pregnancies, abortions and birth defects: a population-based perspective. Br J Clin Pharmacol 2007;63:196-205.
16. Bensouda-Grimaldi L, Jonville-Bera AP, Mouret E, et al. Isotretinoin: compliance with recommendations in childbearing women. Ann Dermatol Venereol 2005;132:415-23.
17. Pinheiro SP, Kang EM, Kim CY, et al. Concomitant use of isotretinoin and contraceptives before and after iPledge in the United States. Pharmacoepidemiol Drug Saf 2013;22:1251-7.
18. Shin J, Cheetham TC, Wong L, 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.
19. Stichting Perinatale Registratie Nederland. Grote Lijnen 1999-2012. Urecht: Stichting Perinatale Registratie Nederland, 2013.
20. Roaccutane Summary of Product Characteristics. http://db.cbg-meb.nl/IB-teksten/h10305.pdf (accessed 3 Jan 2014).
21. Smeets JGE, Grooten SJJ, Bruinsma M, et al. NHG-standard acne. Huisarts Wet 2007;50:259-68.
22. Implementatie Bijzonder Kenmerk: 'Let op zwangerschaps preventieprogramma' in Z-index. 2009. https://www.z-index.nl/g-standaard/beschrijvingen/functioneel/wijzigingen/mb/bijzondere-kenmerken/IR%20BK%20Zwangerschapspreventiepro gramma%20V-1-1-1.pdf (accessed 3 Mar 2014).
23. College ter Beoordeling van Geneesmiddelen/Medicines Evaluation Board (CBG/MEB). Zwangerschapspreventie programmas (ZPP). http://www.cbg-meb.nl/CBG/nl/humane-geneesmiddelen/geneesmiddelenbew/zwangerschapspreventieprogramma/default.htm (accessed 3 Mar 2014).
24. Commissie Farmaceutische Hulp. Isotretinoïne: waarschuwingen en voorzorgen. Farmacotherapeutisch kompas. College van Zorgverzekeringen, 2007.
25. Crijns HJ, Straus SM, Gispen-de Wied C, et al. Compliance with pregnancy prevention programmes of isotretinoin in Europe: a systematic review. Br J Dermatol 2011;164:238-44.
26. Fledderus S. Zwangerschapspreventie bij teratogene middelen faalt. Medisch Contact 2012;48:2692.
27. Manders KC, de Vries LC, Roumen FJ. Pregnancy after isotretinoin use. Ned Tijdschr Geneeskd 2013;157:A6567.
28. Crijns HJ. Teratogene middelen: zwangerschapspreventie kan beter. 2012. http://www.pw.nl/nieuws/nieuwsberichten/2012/teratogenemiddelen-zwangerschapspreventie-kan-beter (accessed 3 Mar 2014).