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| Research article summary (published 7 Mar 1994): |
Neurodevelopment of children exposed in utero to phenytoin and carbamazepine monotherapy.
Full Abstract
OBJECTIVE--To compare pregnancy outcome prospectively after phenytoin and carbamazepine monotherapy with outcome in matched mother-child pairs exposed to nonteratogens to evaluate the relative fetal safety of these drugs. DESIGN--A prospective, controlled, and blinded observational study. PATIENTS--Thirty-six mother-child pairs exposed to carbamazepine monotherapy and 34 pairs exposed to phenytoin monotherapy, all prospectively studied, were compared with mother-child pairs exposed to nonteratogens. The controls were matched for maternal age, time of consultation, obstetric history, and socioeconomic status. MAIN OUTCOME MEASURE--The primary end point of interest was the children's global IQ measured by either the Bayley or the McCarthy scale according to their ages. SETTING--A teratology consultation program and two neurology services in Toronto, Ontario. RESULTS--Children exposed to phenytoin in utero had a mean (+/- SD) global IQ 10 points lower (95% confidence interval, 4.9 to 15.8 points) than their matched controls (113.4 +/- 13.1 and 103.1 +/- 25.1; P = .038). The Reynell language development scores followed a similar trend, with children exposed to phenytoin scoring significantly lower than their controls. Phenytoin-exposed children had a global IQ of 84 or less significantly more often than the control group (P < .01). Children exposed in utero to carbamazepine did not differ from their controls on any of the neurobehavioral tests. CONCLUSIONS--Our study suggests a clinically important negative effect of phenytoin on neurobehavioral development, independent of maternal or environmental factors, causing a substantial number of children to achieve a lower score than expected on cognitive tests. No similar effects could be shown after gestational use of carbamazepine.
Author information
Author/s: Scolnik, D (D); Nulman, I (I); Rovet, J (J); Gladstone, D (D); Czuchta, D (D); Gardner, H A (HA); Gladstone, R (R); Ashby, P (P); Weksberg, R (R); Einarson, T (T);
Affiliation: Motherisk Program, Hospital for Sick Children, Toronto, Ontario, Canada.
Journal and publication information
Publication Type: Journal Article; Research Support, Non-U.S. Gov't
Journal: JAMA : the journal of the American Medical Association (JAMA), published in UNITED STATES. (Language: eng)
Reference: 1994-Mar; vol 271 (issue 10) : pp 767-70
Dates: Created 1994/03/30; Completed 1994/03/30; Revised 2006/11/15;
PMID: 7509419, status: MEDLINE (last retrieval date: 2/18/2009, IMS Date: )
Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.
Comments and Corrections
CommentIn: JAMA. 1994 Sep 21;272(11):850-1. (PMID: 7521402)
CommentIn: JAMA. 1994 Sep 21;272(11):850; author reply 851. (PMID: 7521401)
ErratumIn: JAMA 1994 Jun 8;271(22):1745.
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