Safety of medications prescribed before and during early pregnancy in a cohort of 81 975 mothers from the UK general practice research database

Pharmacoepidemiology and Drug Safety

Volumn 15, Issue 8, 2006, Pages 555-564

  Hardy, Janet R ^a   Leaderer, Brian P ^b   Holford, Theodore R ^b   Hall, Gillian C ^c   Bracken, Michael B ^b,d  

^a UNIVERSITY OF MASSACHUSETTS MEDICAL SCHOOL   (United States)

^b YALE UNIVERSITY   (United States)

^c Yale University School of Medicine ^*

^d YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Cohort studies; Drug prescriptions; Factual databases; Medical record linkage; Pregnancy; Pregnancy trimester first

Indexed keywords

ALGINIC ACID; ANALGESIC AGENT; ANTACID AGENT; ANTHELMINTIC AGENT; ANTIDEPRESSANT AGENT; ANTIEMETIC AGENT; ANTIFUNGAL AGENT; ANTIHISTAMINIC AGENT; ANTIINFECTIVE AGENT; ANTIINFLAMMATORY AGENT; ANXIOLYTIC AGENT; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; BRONCHODILATING AGENT; CONTRACEPTIVE AGENT; DECONGESTIVE AGENT; DIMETICONE; DIURETIC AGENT; FOLIC ACID; HYPNOTIC AGENT; HYPOPHYSIS HORMONE; IRON; NARCOTIC ANALGESIC AGENT; NONSTEROID ANTIINFLAMMATORY AGENT; ORAL CONTRACEPTIVE AGENT; OXYBUTYNIN; PROGESTERONE; SPASMOLYTIC AGENT; STEROID; UNINDEXED DRUG; VACCINE;

ADULT; ALGORITHM; ARTICLE; AUTOMATION; COHORT ANALYSIS; CONTROLLED STUDY; DATA BASE; DRUG CLASSIFICATION; DRUG CONTRAINDICATION; DRUG SAFETY; DRUG USE; FEMALE; FIRST TRIMESTER PREGNANCY; FOOD AND DRUG ADMINISTRATION; GENERAL PRACTICE; HUMAN; MAJOR CLINICAL STUDY; MEDICAL RECORD; MEDICAL RESEARCH; METHODOLOGY; PRENATAL SCREENING; PRESCRIPTION; PRIORITY JOURNAL; RISK ASSESSMENT; UNITED KINGDOM;

ADULT; DATABASES, FACTUAL; DRUG PRESCRIPTIONS; DRUG THERAPY; DRUG UTILIZATION; FEMALE; GREAT BRITAIN; HUMANS; MEDICAL RECORDS SYSTEMS, COMPUTERIZED; MOTHERS; PREGNANCY; PRESCRIPTIONS, DRUG; TERATOGENS;

EID: 33748349628     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.1269     Document Type: Article

References (32)

1. Brewer T, Colditz GA. Postmarketing surveillance and adverse drug reactions: current perspectives and future needs. JAMA 1999; 281: 824-829.
2. Lagoy CT, Joshi N, Cragan JD, Rasmussen SA. Medication use during pregnancy and lactation: an urgent call for public health action. J Womens Health 2005; 14: 104-109.
3. Shields K, Wiholm B, Hostelley L, et al. Monitoring outcomes of pregnancy following drug exposure. Drug Saf 2004; 27: 353-368.
4. Koren G, Pastuszak A. Ito S. Drugs in pregnancy. N Engl J Med 1998; 338: 1128-1137.
5. Doering PL, Boothby LA, Cheok M. Review of pregnancy labeling of prescription drugs: is the current system adequate to inform of risks?. Am J Obstet Gynecol 2002; 187: 333-339.
6. Rubin P. Fortnightly review: drug treatment during pregnancy. Br Med J 1998; 317: 1503-1506.
7. Stevenson RE. Human Malformations and Related Anomalies. Oxford University Press: New York, 1993.
8. Bracken MB. Chapter 18: Methodologic issues in the epidemiologic investigation of drug-induced congenital malformations. In Perinatal Epidemiology (1st edn), Bracken M, (ed.). Oxford University Press: New York, NY, 1984; 423-449.
9. Office for National Statistics. Key health statistics from General Practice 1998: analyses of morbidity and treatment data, including time trends, England and Wales. Office of National Statistics: London, 1998; 1-175.
10. Wood L, Coulson R. Revitalizing the General Practice Research Database: plans, challenges, and opportunities. Pharmacoepidemiol Drug Saf 2001; 10: 379-383.
11. Lawson DH, Sherman V, Hollowell J. The General Practice Research Database [Commentary]. Q J Med 1998; 91: 445-452.
12. Hollowell J. The General Practice Research Database: quality of morbidity data. Popul Trends 1997; 87: 36-40.
13. Office for National Statistics. The General Practice Research Database: information for researchers. Office for National Statistics: London, 1996; 1-21.
14. Walley T, Mantgani A. The UK General Practice Research Database. Lancet 1997; 350: 1097-1099.
15. Wood L, Martinez C. The General Practice Research Database: role in pharmacovigilance. Drug Saf 2004; 27: 871-881.
16. Hardy JR, Holford TR, Hall GC, Bracken MB. Strategies for identifying pregnancies in the automated medical records of the General Practice Research Database. Pharmacoepidemiol Drug Saf 2004; 13: 749-824.
17. British National Formulary. The British National Formulary 49 Online 2004, http://www.bnf.org, (December 2004).
18. Garcia-Rodriquez LA, Gutthann SP. Use of the UK General Practice Research Database for pharmacoepidemiology. Br J Clin Pharmacol 1998; 45: 419-425.
19. Food and Drug Administration. Pregnancy labeling. FDA Drug Bull 1979; 23-24.
20. Food and Drug Administration. FDA categories for drug use in pregnancy. Fed Regist 1980; 44: 37434-37467.
21. Schatz M. Asthma during pregnancy: interrelationships and management. Ann Allergy 1992; 68: 123-133.
22. Larimore WL. Medications used in pregnancy and lactation. 1st ed. Medscape 1998, http://www.medscape.com (December 1999).
23. FASS. Classification of medical products for use during pregnancy and lactation: The Swedish system. LINFO, Drug Information Ltd: Stockholm, 1993.
24. Australian Drug Evaluation Committee. Medicines in Pregnancy Working Party: Australian categorisation of drugs. (4th ed.) Australian Government: Department of Health and Ageing, 1989.
25. De Santis M, Straface G, Carducci B, et al. Risk of drug-induced congenital defects. Eur J Obstet Gynecol Reprod Biol 2004; 117: 10-19.
26. Oates-Whitehead RM, Haas DM, Carrier JAK. Progestogen for preventing miscarriage. Cochrane Database Syst Rev 2003; 4: CD003511.
27. 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: 245-253.
28. Andrade SE, Gurwitz JH, Davis RL, et al. Prescription drug use in pregnancy. Am J Obstet Gynecol 2004; 191: 298-407.
29. Cooper WO, Hickson GB, Ray W. Prescriptions for contraindicated category X drugs in pregnancy among women enrolled in TennCare. Paediatr Perinat Epidemiol 2004; 18: 106-111.
30. Olesen C, Sorensen HT, de Jong-van den Berg L, et al. Prescribing during pregnancy and lactation with reference to the Swedish classification system. A population-based study among Danish women. Acta Obstet Gynecol Scand 1999; 78: 686-692.
31. Lacroix I, Damase-Michel C, Lapeyre-Mestre M, Montastruc JL. Prescription of drugs during pregnancy in France. Lancet 2000; 356: 1735-1736.
32. Riley EH, Fuentes-Afflick E, Jackson RA, et al. Correlates of prescription drug use during pregnancy. J Womens Health 2005; 14: 401-409.