Thiogamma I.V. Use In Pregnancy & Lactation

In accordance with the general principles of pharmacotherapy, medicines should be used during pregnancy and lactation only after careful consideration of the benefit/risk ratio. Animal studies are insufficient with respect to reproductive toxicity.
Pregnancy: Animal studies have not demonstrated teratogenic effects associated with thioctic acid. However, fetal risk in human cannot be ruled out. The available evidence is inconclusive or is inadequate for determining fetal risk of the product when used in pregnant women or women of childbearing potential. There are no adequate studies in humans. It is not known whether thioctic acid crosses the placenta and if it is responsible for any fetal adverse effects.
Breastfeeding: It is unknown whether thioctic acid is excreted in human breast milk. Breastfeeding women should start treatment with thioctic acid only after careful determination of the indication by a physician even though the reproductive toxicological studies have not resulted in any evidence regarding the effect on fertility, early embryonal development and showed no embryotoxic properties.
The effects on the nursing infant from exposure to the drug in breast milk are unknown. The use of thioctic acid while breast feeding is not recommended.
Fertility: It is unknown whether thioctic acid has an effect on fertility.