Document Detail

Minor malformations characteristic of the retinoic acid embryopathy and other birth outcomes in children of women exposed to topical tretinoin during early pregnancy.
MedLine Citation:
PMID:  15940677     Owner:  NLM     Status:  MEDLINE    
Topical tretinoin (Retin-A) is used to treat acne and photodamaged skin. Its teratogenic potential is of concern due to its similarity to isotretinoin (Accutane), a recognized human teratogen. Through the California Teratogen Information Service and Clinical Research Program, between 1983 and 2003, 106 pregnant women with first-trimester exposure to topical tretinoin were prospectively ascertained and followed. Birth outcomes, including pregnancy loss, major structural defects, and pre- and postnatal growth were compared to 389 similarly and prospectively ascertained women with no topical tretinoin exposure during pregnancy. Because a distinct pattern of malformation had already been described for isotretinoin, we also compared exposed (n = 62) and unexposed (n = 191) infants on the prevalence of a specific subset of minor malformations selected to represent the spectrum of defects comprising the retinoic acid embyopathy. There were no significant differences between groups in the proportion of pregnancies ending in spontaneous abortion (6.6% in exposed vs. 8.5% in unexposed; P = 0.53), or infants with major structural defects (2.2% in exposed vs. 1.2% in unexposed; P = 0.62). In addition, the groups were similar in birth weight, length and head circumference, and there were no significant differences between groups in length of gestation. Furthermore, the prevalence of one or more retinoic acid-specific minor malformations did not differ significantly between groups (12.9% in exposed vs. 9.9% in unexposed; P = 0.51). First-trimester topical tretinoin exposure in this study was not associated with an increased risk of any adverse pregnancy outcome evaluated. Specifically, there was no indication that topical tretinoin is associated with an increased risk for minor malformations that are consistent with the retinoic acid embryopathy. Although it is impossible to exclude the possibility that some women/infants may be uniquely susceptible to topical tretinoin exposure, this study provides further reassurance for women who are inadvertently exposed early in pregnancy.
Kirsten D Loureiro; Kelly K Kao; Kenneth Lyons Jones; Sonia Alvarado; Carmen Chavez; Lyn Dick; Robert Felix; Diana Johnson; Christina D Chambers
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Publication Detail:
Type:  Comparative Study; Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  American journal of medical genetics. Part A     Volume:  136     ISSN:  1552-4825     ISO Abbreviation:  Am. J. Med. Genet. A     Publication Date:  2005 Jul 
Date Detail:
Created Date:  2005-06-29     Completed Date:  2005-09-14     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  101235741     Medline TA:  Am J Med Genet A     Country:  United States    
Other Details:
Languages:  eng     Pagination:  117-21     Citation Subset:  IM    
Copyright Information:
Copyright 2005 Wiley-Liss, Inc.
Graduate School of Public Health, San Diego State University, CA 92103, USA.
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MeSH Terms
Abnormalities, Drug-Induced / epidemiology,  etiology*
California / epidemiology
Cohort Studies
Gestational Age
Infant, Newborn
Keratolytic Agents / administration & dosage,  adverse effects*,  therapeutic use
Pregnancy Trimester, First
Prenatal Exposure Delayed Effects*
Prospective Studies
Tretinoin / administration & dosage,  adverse effects*,  therapeutic use
Reg. No./Substance:
0/Keratolytic Agents; 302-79-4/Tretinoin

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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