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A case-control study evaluating associations between several common non-cardiac malformations and multiple antiemetic drugs reported an association between maternal use of ondansetron and isolated cleft palatereported adjusted OR2.3795CI1.184.76Howeverthis association could be a chance findinggiven the large number of drugs-birth defect comparisons in this studyIt is unknown whether ondansetron exposure in utero in the cases of cleft palate occurred during the time of palate formationthe palate is formed between the 6 th and 9 th weeks of pregnancyor whether mothers of infants with cleft palate used other medications or had other risk factors for cleft palate in the offspringIn additionno cases of isolated cleft palate were identified in the aforementioned 2 large retrospective cohort studiesAt this timethere is no clear evidence that ondansetron exposure in early pregnancy can cause cleft palate.

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