Document Detail

Teratogenic risk with etretinate and acitretin treatment.
MedLine Citation:
PMID:  8075435     Owner:  NLM     Status:  MEDLINE    
Etretinate (Tigason, Tegison) and its active metabolite acitretin (Neotigason, Soriatane) are known teratogens. Pregnancy should be avoided during treatment and until 2 years after treatment discontinuation. The question is discussed whether a dose or a blood concentration of the drug below which there is no teratogenic risk can be determined. Animal experimental and human pharmacokinetic data are reviewed. An evaluation of the outcomes of pregnancies which occurred in mothers exposed to etretinate or acitretin was performed. A threshold dose in human therapy below which there is no risk of congenital malformation cannot be determined based on animal experimental data. With regard to pharmacokinetics, there are currently no data suggesting that blood levels of the drug below the detection limit of 2 ng/ml are associated with a teratogenic risk. The most useful information is given by reports in women who were exposed to either retinoid before or during pregnancy. The data indicate that the risk of spontaneous abortion or congenital malformation is high when the drug is administered during the first trimester of pregnancy. After treatment discontinuation, the risk is low since the number of abnormalities seems not to exceed those observed in a general population. There are currently no available data which suggest that the pregnancy warnings are inappropriate in terms of duration of contraception.
J M Geiger; M Baudin; J H Saurat
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Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  Dermatology (Basel, Switzerland)     Volume:  189     ISSN:  1018-8665     ISO Abbreviation:  Dermatology (Basel)     Publication Date:  1994  
Date Detail:
Created Date:  1994-10-04     Completed Date:  1994-10-04     Revised Date:  2005-11-16    
Medline Journal Info:
Nlm Unique ID:  9203244     Medline TA:  Dermatology     Country:  SWITZERLAND    
Other Details:
Languages:  eng     Pagination:  109-16     Citation Subset:  IM    
Roche International Clinical Research Center, Strasbourg, France.
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MeSH Terms
Abnormalities, Drug-Induced / blood,  etiology*,  prevention & control
Acitretin / adverse effects*,  pharmacokinetics,  therapeutic use
Contraceptives, Oral / administration & dosage*
Dose-Response Relationship, Drug
Etretinate / adverse effects*,  pharmacokinetics,  therapeutic use
Fetal Diseases / blood,  chemically induced*,  prevention & control
Infant, Newborn
Maternal-Fetal Exchange
Pregnancy Outcome
Prenatal Exposure Delayed Effects*
Reproducibility of Results
Risk Factors
Reg. No./Substance:
0/Contraceptives, Oral; 54350-48-0/Etretinate; 55079-83-9/Acitretin

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

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