Skip to Content

Tiotropium Pregnancy and Breastfeeding Warnings

Tiotropium is also known as: Spiriva, Spiriva Respimat

Medically reviewed by Drugs.com. Last updated on Mar 15, 2019.

Tiotropium Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

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

Comments:
-The limited data available on use in pregnant women are insufficient to know this drugs risks, including the risk of fetal harm or reproductive effects.
-Poorly controlled asthma during pregnancy increases the risk of preeclampsia, premature birth, low birth weight, and small for gestational age.
-Closely monitor asthma control during pregnancy and adjust therapy as needed for optimal control.

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. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.

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

The manufacturer makes no recommendation regarding use during lactation.

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

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-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. "UK Summary of Product Characteristics." O 0
  5. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

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

Hide