Gavilyte-c with lemon flavor pack Pregnancy Warnings
Use is not recommended unless clearly needed.
AU TGA pregnancy category: B1
US FDA pregnancy category: C
Animal studies have shown indirect reproductive toxicity, including reduction in fetal and placental weight, reduced fetal viability, increased limb and paw hyperflexion, and abortions at maternally toxic doses; there was no indication of teratogenicity. There are no controlled data in human pregnancy. No clinical effects are anticipated during pregnancy, as systemic exposure is negligible.
AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
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