Pentetate calcium trisodium Pregnancy and Breastfeeding Warnings
Brand names: AN-DTPA
Pentetate calcium trisodium Pregnancy Warnings
This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.
US FDA pregnancy category: C
Comments:
-Chelation in pregnant women should be done with pentetate zinc trisodium, if available, unless there is high internal radiocontamination.
-This drug depletes zinc, which is essential for fetal development.
-Because this product is more effective than pentetate zinc trisodium in the first 24 hours after internal contamination, a single dose - with zinc containing vitamin or mineral supplements - may be appropriate.
Animal studies showed embryotoxicity and teratogenicity; gross malformations and fetal mortality increased with dose, with higher susceptibility in early and mid gestation. 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.
Pentetate calcium trisodium Breastfeeding Warnings
Safety has not been established.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-Radiocontaminants are excreted in breast milk.
-Women with known or suspected radioactive contamination should not breast feed.
-Precautions should be taken when discarding breast milk.
See also
References for pregnancy information
- Product Information. Pentetate Calcium Trisodium (pentetate calcium trisodium). Akorn Inc. 2005.
References for breastfeeding information
- Product Information. Pentetate Calcium Trisodium (pentetate calcium trisodium). Akorn Inc. 2005.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.