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Tiotropium Pregnancy and Breastfeeding Warnings

Tiotropium is also known as: Spiriva, Spiriva Respimat

Tiotropium Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B1 US FDA pregnancy category: C Comments: The safety and effectiveness have not been studied during labor and delivery.

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant doses. There is a very limited amount of data regarding the use of tiotropium in pregnant women. 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.

Tiotropium Breastfeeding Warnings

US: Caution is recommended. AU, UK: 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 Comments: The effects in the nursing infant are unknown.

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