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Topiramate use in pregnancy and the birth prevalence of oral clefts
Pharmacoepidemiology and drug safety, 2014-10, Vol.23 (10), p.1017-1025
Mines, Daniel
Tennis, Patricia
Curkendall, Suellen M.
Li, De-Kun
Peterson, Craig
Andrews, Elizabeth B.
Calingaert, Brian
Chen, Hong
Deshpande, Gaurav
Esposito, Daina B.
Everage, Nicholas
Holick, Crystal N.
Meyer, Nicole M.
Nkhoma, Ella T.
Quinn, Sherry
Rothman, Kenneth J.
Chan, K. Arnold
2014
Details
Autor(en) / Beteiligte
Mines, Daniel
Tennis, Patricia
Curkendall, Suellen M.
Li, De-Kun
Peterson, Craig
Andrews, Elizabeth B.
Calingaert, Brian
Chen, Hong
Deshpande, Gaurav
Esposito, Daina B.
Everage, Nicholas
Holick, Crystal N.
Meyer, Nicole M.
Nkhoma, Ella T.
Quinn, Sherry
Rothman, Kenneth J.
Chan, K. Arnold
Titel
Topiramate use in pregnancy and the birth prevalence of oral clefts
Ist Teil von
Pharmacoepidemiology and drug safety, 2014-10, Vol.23 (10), p.1017-1025
Ort / Verlag
Chichester: Blackwell Publishing Ltd
Erscheinungsjahr
2014
Link zum Volltext
Quelle
Wiley-Blackwell Journals
Beschreibungen/Notizen
ABSTRACT Purpose First marketed in the USA in 1996, topiramate (TPM) is an antiepileptic drug later approved for migraine prophylaxis, and in 2012 for weight loss in combination with phentermine. Some studies indicate an elevated prevalence of oral cleft (OC) in infants exposed to TPM in utero. We evaluated the association between TPM use in early pregnancy and the risk of OC. Methods This retrospective cohort study used 1997–2011 automated data from four sources: HealthCore and OptumInsight (commercial insurance claims), Truven Health (Medicaid claims), and Kaiser Permanente Northern California Region (electronic medical records). We compared the prevalence of OCs in infants of women exposed to TPM in the first trimester (TPM cohort) with the prevalence in infants of women formerly exposed to TPM or other antiepileptic drugs (formerly exposed [FE] cohort) and infants of women with similar medical profiles (SMPs) to the TPM cohort that were not exposed to TPM (SMP cohort). To control for confounding, we used stratification and standardization for individual variables and propensity score deciles. Results The birth prevalence of OCs was 0.36% (7/1945) in the TPM cohort, 0.14% (20/13 512) in the FE cohort, and 0.07% (9/13 614) in the SMP cohort. Standardized by site, the prevalence ratio (PR) for TPM versus FE was 2.5 (95% CI: 1.0–6.0) and for TPM versus SMP was 5.4 (95% CI: 2.0–14.6). Adjustment for covariates one at a time or by propensity score yielded similar results. Conclusion Consistent with other recent epidemiologic research, first‐trimester TPM exposure was associated with an elevated birth prevalence of OC. Copyright © 2014 John Wiley & Sons, Ltd.
Sprache
Englisch
Identifikatoren
ISSN: 1053-8569
eISSN: 1099-1557
DOI: 10.1002/pds.3612
Titel-ID: cdi_proquest_miscellaneous_1612990313
Format
–
Schlagworte
abnormalities
,
Biological and medical sciences
,
California - epidemiology
,
cleft lip
,
Cleft Lip - chemically induced
,
Cleft Lip - epidemiology
,
cleft palate
,
Cleft Palate - chemically induced
,
Cleft Palate - epidemiology
,
Clinical trial. Drug monitoring
,
Cohort Studies
,
Databases, Factual
,
delayed effects
,
drug induced
,
Electronic Health Records
,
Female
,
Fructose - administration & dosage
,
Fructose - adverse effects
,
Fructose - analogs & derivatives
,
Fructose - therapeutic use
,
General pharmacology
,
Humans
,
Infant, Newborn
,
Medical sciences
,
oral cleft
,
pharmacoepidemiology
,
Pharmacology. Drug treatments
,
Pregnancy
,
prenatal exposure
,
Prenatal Exposure Delayed Effects - chemically induced
,
Prenatal Exposure Delayed Effects - epidemiology
,
Prevalence
,
Retrospective Studies
,
topiramate
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