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Debendox revisited.

D Elbourne, L Mutch, M Dauncey

    British Journal of Obstetrics and Gynaecology
    |August 1, 1985
    PubMed
    Summary
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    Two studies on Debendox (Bendectin) and oral clefts found no increased risk. These findings do not confirm previous associations between Debendox exposure in pregnancy and oral clefts in children.

    Area of Science:

    • Obstetrics and Gynecology
    • Pediatric Health
    • Teratology

    Background:

    • Previous research suggested a potential link between Debendox (Bendectin) use during pregnancy and oral clefts.
    • This association was based on findings from a study in Oxford.

    Purpose of the Study:

    • To re-examine the association between Debendox exposure in early pregnancy and the occurrence of oral clefts.
    • To validate or refute the findings of Golding et al. (1983).

    Main Methods:

    • Two independent cohort studies were conducted in Cardiff and Aberdeen.
    • Case-control methodology was employed, comparing infants with oral clefts to matched controls.
    • Exposure to Debendox was assessed based on prescription records within a specific timeframe of the last menstrual period.

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    Main Results:

    • In Cardiff, the relative risk of oral clefts for Debendox-exposed pregnancies was 0.64 (95% CI 0.12-3.34).
    • In Aberdeen, the risk for Debendox-exposed pregnancies was 0.37 (95% CI 0.09-1.47).
    • No increased risk was observed, even among women who smoked.

    Conclusions:

    • The findings from both studies do not support a link between Debendox use in early pregnancy and oral clefts.
    • These results contradict the earlier Oxford study's conclusions regarding Debendox and oral clefts.