Dalteparin Pregnancy and Breastfeeding Warnings
Brand names: Fragmin
Medically reviewed by Drugs.com. Last updated on Nov 17, 2023.
Dalteparin Pregnancy Warnings
Animal studies have failed to reveal evidence of teratogenicity or fetotoxicity. There are no controlled data in human pregnancy. Uncontrolled human pregnancy data indicate no fetal or neonatal toxicity. Therapeutic failures have been reported in pregnant women with prosthetic heart valves on full anticoagulant doses of low molecular weight heparin.
AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.
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.
This drug should be used during pregnancy only if clearly needed.
AU TGA pregnancy category: C
US FDA pregnancy category: Not Assigned
Risk Summary: Preterm infants may experience adverse effects when this drug is used during pregnancy, but no clear association between this drug and adverse developmental outcomes has been reported.
Dalteparin Breastfeeding Warnings
AU and 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.
US: Benefit should outweigh risk.
Excreted into human milk: Yes
Comments: This drug has been used without apparent harmful effects in the nursing infant.
See also
References for pregnancy information
- Product Information. Fragmin (dalteparin). Pharmacia and Upjohn. 2001;PROD.
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- Cerner Multum, Inc. Australian Product Information.
References for breastfeeding information
- Product Information. Fragmin (dalteparin). Pharmacia and Upjohn. 2001;PROD.
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- Cerner Multum, Inc. Australian Product Information.
- United States National Library of Medicine. Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT 2013.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
