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Colesevelam Pregnancy and Breastfeeding Warnings

Colesevelam is also known as: Welchol

Medically reviewed by Drugs.com. Last updated on Jun 25, 2019.

Colesevelam Pregnancy Warnings

Animal studies have failed to reveal evidence of fetal harm. There have been infrequent reports of pregnancy in the postmarketing period and a causal association with congenital anomalies has not been established. There are no controlled data in human pregnancy.

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.

Benefit should outweigh risk

US FDA pregnancy category: Not assigned

Risk Summary: Maternal use is not expected to result in fetal exposure, however, there are limited data on the use of this drug in pregnancy to inform a drug-associated risk of major congenital malformations or miscarriage.

Comments:
-This drug may decrease the absorption of fat soluble vitamins; if a women becomes pregnant while taking this drug, she should be advised of the lack of known clinical benefit with continued use during pregnancy.
-Females of reproductive potential should be

See references

Colesevelam Breastfeeding Warnings

Use is considered acceptable

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

Comments:
-This drug is a nonabsorbable resin and is not expected to be excreted into human milk because it is not absorbed systemically from the gastrointestinal tract.

See references

References for pregnancy information

  1. "Product Information. Welchol (colesevelam)" Daiichi Sankyo, Inc., Parsippany, NJ.
  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. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  3. "Product Information. Welchol (colesevelam)" Daiichi Sankyo, Inc., Parsippany, NJ.

Further information

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

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