Document Detail

A prospective cohort study of pregnancy outcomes of women inadvertently exposed to methylephedrine in the 1st trimester of pregnancy.
MedLine Citation:
PMID:  20701502     Owner:  NLM     Status:  MEDLINE    
No information is currently available on the safety of methylephedrine, a component of various cold medications available in South Korea. With previous approval by an Institutional Review Board, 349 women inadvertently exposed to methylephedrine during the 1st trimester of pregnancy and an age- and gravidity-matched control group, were enrolled in a prospective cohort study. Study outcomes, for example gestational age at birth, birth weight and major and minor malformations were evaluated in 282 cases and 280 controls. Exposure to methylephedrine was at a gestational age of 4.0 weeks (median), at doses ranging from 52.5 to 1,575 mg/day, for a median duration of 3 (range: 1-30) days. No differences were observed between cases and controls in any of the pregnancy outcomes studied. There were 4/265 (1.5%) babies born with major malformations in the case group and 4/260 (1.5%) in the control group. In conclusion, inadvertent exposure to methylephedrine as a component of over-the counter oral cold remedies in early pregnancy was not associated with an increased rate of adverse pregnancy outcomes. Co-exposure with acetaminophen, cigarette smoking or alcohol did not appear to modify the outcomes.
H J Lee; J Y Han; J H Yook; J S Choi; H K Ahn; M Y Kim; I O Song; J H Yang; A A Nava-Ocampo
Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology     Volume:  30     ISSN:  1364-6893     ISO Abbreviation:  J Obstet Gynaecol     Publication Date:  2010  
Date Detail:
Created Date:  2010-08-12     Completed Date:  2011-01-03     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8309140     Medline TA:  J Obstet Gynaecol     Country:  England    
Other Details:
Languages:  eng     Pagination:  563-6     Citation Subset:  IM    
Korean Motherisk Program, Department of Obstetrics and Gynecology, Cheil Hospital and Women's Healthcare Center, Kwandong University College of Medicine, Seoul, Korea.
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MeSH Terms
Abnormalities, Drug-Induced / etiology
Birth Weight / drug effects*
Cohort Studies
Ephedrine / adverse effects,  analogs & derivatives*
Gestational Age
Maternal Exposure*
Pregnancy Outcome*
Pregnancy Trimester, First
Prospective Studies
Republic of Korea
Reg. No./Substance:
17605-71-9/N-methylephedrine; 299-42-3/Ephedrine

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