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Linaclotide Pregnancy and Breastfeeding Warnings

Linaclotide is also known as: Linzess

Medically reviewed on September 19, 2017

Linaclotide Pregnancy Warnings

Animal studies have revealed adverse fetal effects only with maternal toxicity and at doses much higher than the maximum recommended human dose. There are no controlled data in human pregnancy.

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.

Use should be avoided unless the benefit outweighs the risk to the fetus.

US FDA pregnancy category: C

See references

Linaclotide Breastfeeding Warnings

US: Caution is recommended.
UK: Use is not recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments: The effects in the nursing infant are unknown.

The drug and its active metabolite are not measurable in plasma following administration of the recommended clinical doses.

See references

References for pregnancy information

  1. "Product Information. Linzess (linaclotide)." Forest Pharmaceuticals, St. Louis, MO.
  2. 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. "Product Information. Linzess (linaclotide)." Forest Pharmaceuticals, St. Louis, MO.

Further information

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

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