The manufacturer, glaxosmithkline gsk , did not test if zofran is safe during pregnancy, nor ask for approval to use in pregnant women.
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No overall differences in safety or effectiveness were observed between subjects 65 years of age and older and younger subjectsA reduction in clearance and increase in elimination half-life were seen in patients older than 75 years compared with younger subjectssee CLINICAL PHARMACOLOGYTherewere an insufficient number of patients older than 75 years of age and older in the clinical trials to permit safety or efficacy conclusions in this age-groupOther reported clinical experience has not identified differences in responses between the . elderly and younger patientsbut greater sensitivity of some older individuals cannot be ruled outNo dosage adjustment is needed in elderly patients.
Methodological limitations of the epidemiology studies preclude a reliable evaluation of the potential risk of adverse fetal outcomes with the use of ondansetron in pregnancy.
In embryo-fetal development studies in rats and rabbitspregnant animals received oral doses of ondansetron up to 15 mg/kg/day and 30 mg/kg/dayrespectivelyduring the period of organogenesisWith the exception of a slight decrease in maternal body weight gain in the rabbitsthere were no significant effects of ondansetron on the maternal animals or the development of the offspringAt doses of 15 mg/kg/day in rats and 30 mg/kg/day in rabbitsthe maternal exposure margin was approximately 6 and 24 times the maximum recommended human oral dose of 24 mg/dayrespectivelybased on body surface area.
Two large retrospective cohort studies of ondansetron use in pregnancy have been publishedIn one study with 1,349 infants born to women who reported the use of ondansetron or received an ondansetron prescription in the first trimesterno increased risk for major congenital malformations was seen in aggregate analysisIn this same studyhowevera sub-analysis for specific malformations reported an association between ondansetron exposure and cardiovascular defectodds ratioOR1.6295CI1.042.14and cardiac septal defectOR 2.0595CI1.193.28The second study examined 1970 women who received ondansetron prescription during pregnancy and reported no association between ondansetron exposure and major congenital malformationsmiscarriage or stillbirthand infants of low-birth weight or small for gestational ageImportant methodological limitations with these studies include the uncertainty of whether women who filled a prescription actually took the medicationthe concomitant use of other medications or treatmentsand other unadjusted confounders that may account for the study findings.
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