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Tiotropium Pregnancy and Breastfeeding Warnings

Tiotropium is also known as: Spiriva, Spiriva Respimat

Medically reviewed on Mar 2, 2017

Tiotropium Pregnancy Warnings

Use should be avoided.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned

Comments: The safety and effectiveness have not been studied during labor and delivery.

Animal studies showed no structural abnormalities when doses 8 and 790 times the maximum recommended human dose were administered during organogenesis; animal models showed increased fetal resorption, litter loss, and decreased numbers of live pups and pup weights, as well as a delay in pup sexual maturation at doses 40 times and 430 times the maximum recommended human dose, as well as maternal toxicity. There are no controlled data in human pregnancy. The limited human data are insufficient to inform a drug-associated risk of adverse pregnancy outcomes.

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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Tiotropium Breastfeeding Warnings

Use is not recommended unless the benefit to mother outweighs the potential risk to the infant.


Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-The effects on the nursing infant and milk production are unknown.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this drug against any potential adverse events on the child from this drug or the mother's underlying condition.
-Lactating rats given 10 mg/kg tiotropium IV had higher concentrations of tiotropium and/or its metabolites in milk than in plasma; due to species specific differences in lactation physiology, the clinical relevance of this is unclear.

See references

References for pregnancy information

  1. "Product Information. Spiriva Respimat (tiotropium)." Boehringer Ingelheim (Canada) Ltd, Burlington, IA.
  2. "Product Information. Spiriva (tiotropium)." Boehringer Ingelheim, Ridgefield, CT.
  3. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregancy. Available from: URL: http://www.tga.gov.au/docs/pdf/medpreg.pdf." ([1999]):
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Spiriva (tiotropium)." Boehringer Ingelheim, Ridgefield, CT.
  4. "Product Information. Spiriva Respimat (tiotropium)." Boehringer Ingelheim (Canada) Ltd, Burlington, IA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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