Liraglutide Pregnancy and Breastfeeding Warnings
Liraglutide Pregnancy Warnings
Type 2 Diabetes Mellitus: Use is not recommended. AU TGA pregnancy category: C US FDA pregnancy category: C Comments: If pregnancy occurs or if a patient wishes to become pregnant, this drug should be withdrawn; consider a treatment switch to insulin. Weight Management: Use is contraindicated US FDA pregnancy category: X Comments: This drug is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm.
Animal data have revealed evidence of increased embryofetal death and fetal abnormalities (including minor fetal skeletal abnormalities, retarded fetal weight, and visceral abnormalities). There are no controlled data in human pregnancy. AU TGA pregnancy category B3: 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 shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits. 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.
Liraglutide Breastfeeding Warnings
In animal studies, this drug was excreted into rat milk at concentrations of approximately 50% of maternal plasma concentrations. Postnatal weight gain was reduced in the offspring of rats treated with this drug during gestation and lactation. This finding may be attributed to reduced maternal food consumption.
Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes The effects in the nursing infant are unknown.
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