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Retinoic acid embryopathy.

E J Lammer, D T Chen, R M Hoar

    The New England Journal of Medicine
    |October 3, 1985
    PubMed
    Summary
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    Isotretinoin, a vitamin A derivative, poses significant teratogenic risks in human pregnancies, causing major malformations. This study highlights the crucial need for awareness regarding isotretinoin

    Area of Science:

    • Teratology
    • Developmental Biology
    • Clinical Pharmacology

    Background:

    • Retinoic acid, a vitamin A analogue, is a known teratogen in animals.
    • Clinical case reports suggest potential human teratogenicity.
    • Isotretinoin is prescribed for severe cystic acne.

    Purpose of the Study:

    • To investigate the human teratogenicity of isotretinoin.
    • To determine the risk of major malformations following fetal exposure.
    • To characterize the pattern of malformations associated with isotretinoin exposure.

    Main Methods:

    • Retrospective and prospective study of 154 human pregnancies with fetal isotretinoin exposure.
    • Analysis of pregnancy outcomes, including elective abortions, spontaneous abortions, and infant malformations.

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  • Calculation of relative risk for major malformations.

    • Main Results:

    • Exposure to isotretinoin was associated with a high relative risk (25.6) for major malformations.
    • 21 out of 154 infants exposed to isotretinoin had major malformations.
    • A characteristic pattern of malformations was observed, affecting craniofacial, cardiac, thymic, and central nervous system structures.

    Conclusions:

    • Isotretinoin is a human teratogen, associated with a distinct pattern of major malformations.
    • The findings support animal study data on retinoid teratogenesis.
    • Potential mechanism involves impaired cephalic neural-crest cell activity.