Post-marketing surveillance system for drugs in pregnancy - 15 Years experience of ENTIS

Reproductive Toxicology

Volumn 20, Issue 3, 2005, Pages 331-343

  Schaefer, Christof ^a   Hannemann, Doreen ^a   Meister, Reinhard ^b  

^a Haus 10 ^*  (Germany)

^b BEUTH UNIVERSITY OF APPLIED SCIENCES   (Germany)

Author keywords

Abnormalities, drug induced; Developmental toxicity; Human; Postmarketing surveillance; Pregnancy; Risk assessment; Teratology; Teratology Information Service

Indexed keywords

CALCIUM CHANNEL BLOCKING AGENT; COUMARIN ANTICOAGULANT; FOLIC ACID; HALOPERIDOL; HISTAMINE H2 RECEPTOR ANTAGONIST; MESALAZINE; PROTON PUMP INHIBITOR; QUINOLONE DERIVATIVE; RETINOL; SEROTONIN UPTAKE INHIBITOR; THIAMAZOLE; TRICYCLIC ANTIDEPRESSANT AGENT; UNCLASSIFIED DRUG; YELLOW FEVER VACCINE;

AUTOMATION; BIRTH RATE; CONGENITAL MALFORMATION; DATA ANALYSIS; DECISION MAKING; DIFFERENTIAL DIAGNOSIS; DRUG CONTRAINDICATION; DRUG INFORMATION; DRUG LABELING; DRUG SAFETY; ECHOCARDIOGRAPHY; EMBRYOLOGY; GESTATIONAL AGE; HAZARD ASSESSMENT; HUMAN; INFORMATION SERVICE; LICENCE; NEURAL TUBE DEFECT; ORGANIZATION; PATIENT COUNSELING; POSTMARKETING SURVEILLANCE; PREGNANCY; PRENATAL DIAGNOSIS; PRENATAL EXPOSURE; REVIEW; RISK ASSESSMENT; SPONTANEOUS ABORTION; STATISTICAL ANALYSIS; TERATOGENESIS; TERATOGENICITY; TERATOLOGY;

ABNORMALITIES, DRUG-INDUCED; ADULT; ADVERSE DRUG REACTION REPORTING SYSTEMS; EUROPE; FEMALE; FOLLOW-UP STUDIES; HUMANS; INFANT, NEWBORN; MATERNAL EXPOSURE; PREGNANCY; PREGNANCY OUTCOME; PRENATAL EXPOSURE DELAYED EFFECTS; PROSPECTIVE STUDIES; RISK ASSESSMENT;

EID: 21744438935     PISSN: 08906238     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.reprotox.2005.03.012     Document Type: Review

References (38)

1. M. Clementi, E. Di Gianantonia, and A. Ornoy Teratology information services in Europe and their contribution to the prevention of congenital anomalies Community Genet 5 2002 8 12
2. E. Eléfant, M. Boyer, P. Boyer, B. Galliot, and C. Roux Teratogenic agent information centre: fifteen years of counseling and pregnancy follow-up Teratology 46 1992 35 44
3. J.M. Garbis, E. Robert, and PW.J. Peters Experience of two teratology information services in Europe Teratology 42 1990 629 634
4. A.R. Scially, J.L. Buelke-Sam, and C.D. Chambers Communicating risks during pregnancy: a workshop on the use of data from animal developmental toxicity studies in pregnancy labels for drugs Birth Defects Res A 70 2004 7 12
5. W.S. Webster, and J.A. Freeman Is this drug safe in pregnancy? Reprod Toxicol 15 2001 619 629
6. J.C.S. Dean, H. Hailey, and S.J. Moore Long term health and neurodevelopment in children exposed to antiepileptic drugs before birth J Med Genet 39 2002 251 259
7. L.B. Holmes, E.A. Harvey, and B.A. Coull The teratogenicity of anticonvulsant drugs N Engl J Med 344 2001 1132 1138
8. E. Kaaja, R. Kaaja, and V. Hiilesmaa Major malformations in offspring of women with epilepsy Neurology 60 2003 575 579
9. G. Koren Teratogen Information Services - the clinical raison d'ètre (abstract) Reprod Toxicol 19 2004 241
10. A. Einarson, F. Ahmed, M. Gallo, T.R. Einarson, and G. Koren Reproducibility of medical information obtained via the telephone vs personal interview Vet Human Toxicol 41 1999 397 400
11. L.B. Holmes Need for inclusion and exclusion criteria for the structural abnormalities recorded in children born from exposed pregnancies Teratology 64 1999 79 82
12. M.L. Martinez-Frias, and E. Rodriguez-Pinilla The problems of using data from teratology information services (TIS) to identify putative teratogens Teratology 60 1999 54 55
13. A. Ornoy, and P. Mastroiacovo More on data from teratogen information systems (TIS) Teratology 61 2000 327 328
14. K.A. Johnson, P.A. Weber, K.L. Jones, and C.D. Chambers Selection bias in teratology information service pregnancy outcome studies Teratology 64 2001 79 82
15. K.L. Jones, D.L. Johnson, and C.D. Chambers Monitoring leflunomide (Arava) as a new potential teratogen Teratology 65 2002 200 202
16. Blettner M. How can cohort and case-control studies complement one another. Presentation, Symposium Epidemiology of Prenatal Toxicology. Annual meeting of European Network of Teratology Information Services (ENTIS). 2001.
17. R.J. Felix, K.L. Jones, K.A. Johnson, C.A. McCloskey, C.D. Chambers For the Organization of Teratology Information Services (OTIS) Collaborative Research Group Postmarketing surveillance for drug safety in pregnancy: the Organization of Teratology Information Services Project Birth Defects Res A 70 2004 944 947
18. C. Schaefer, H. Spielmann, and K. Vetter Arzneiverordnung in Schwangerschaft und Stillzeit 6th ed. 2001 Urban & Fischer München
19. C. Schaefer Drugs during pregnancy and lactation 2001 Elsevier Amsterdam p. 88
20. P. Mastrioacovo, T. Mazzone, and A. Addis High vitamin A intake in early pregnancy and major malformations: a multicenter prospective controlled study Teratology 59 1999 7 11
21. E. Di Gianantonio, C. Schaefer, and P.P. Mastroiacovo Adverse effects of prenatal methimazole exposure Teratology 64 2001 262 266
22. Weber-Schöndorfer C. Calcium blocker during 1st trimester. Presentation of preliminary results. Annual meeting of European Network of Teratology Information Services (ENTIS). 2004.
23. P.R. McElhatton, H.M. Garbis, and E. Eléfant The outcome of pregnancy in 689 women exposed to therapeutic doses of antidepressants. A collaborative study of the European Network of Teratology Information Services (ENTIS) Reprod Toxicol 10 1996 285 294
24. Garbis H, McElhatton P, et al. ENTIS collaborative study of selective serotonin reuptake inhibitors in pregnancy; in preparation.
25. Diav-Citrin O, Arnon J, Shechtman S, et al. The safety of proton pump inhibitors in pregnancy: a multicenter prospective controlled study. Aliment Pharmacol Therap; in press.
26. Diav-Citrin O, Shechtman S, Ornoy S, et al. The safety of haloperidol and penfluridol in pregnancy: a multicenter prospective controlled study. J Clin Psychiatr; in press.
27. H. Garbis, E. Elefant, and O. Diav-Citrin Pregnancy outcome after exposure to ranitidine and other H2-blockers. A collaborative study of the European Network of Teratology Information Services Reprod Toxicol 19 2005 453 458
28. Rost van Tonningen M, Schaefer C, Elefant E, et al. Pregnancy outcome after exposure to mesalazine; in preparation.
29. E. Robert, T. Vial, and C. Schaefer Exposure to yellow fever vaccine in early pregnancy Vaccine 17 1999 283 285
30. C. Schaefer, E. Amoura-Elefant, and T. Vial Pregnancy outcome after prenatal quinolone exposure Eur J Obstet Gynecol Reprod Biol 69 1996 83 89
31. D. Kleinbaum, and M. Klein Survival analysis. A self-learning text series: statistics for biology and health 2nd ed. 1997 Springer New York
32. D.R. Cox Regression models and life tables (with discussion) J Roy Statist Soc Ser B 34 1972 187 220
33. J.P. Klein, and M.L. Moeschberger Survival analysis techniques for censored and truncated data 2nd ed. 2003 Springer New York
34. ISDB (International Society of drug bulletins) EU: Berlin declaration on pharmacovigilance. Berlin, January 2005 (http://www.isdbweb.dspace.it/pag/).
35. N. Biller-Andorno, and V. Wild Arzneimittelforschung an Schwangeren Besonderer Schutz - aber kein Ausschluss aus der Forschung Dtsch Ärztebl 100 2003 C760 C762
36. G.G. Briggs, R.K. Freeman, and S.J. Yaffe Classification of drugs for teratogenic risk: an anachronistic way of counseling: a reply to Merlob and Stahl Birth Defects Res A 67 2003 207 208
37. C. Schaefer, H. Spielmann, and K. Vetter Arzneimittelforschung an Schwangeren. Liberalisierung nicht erforderlich Dtsch Ärztebl 101 2004 165 166
38. B. Källén Epidemiology of human reproduction 1988 CRC Press Boca Raton p. 185