Triclabendazole Pregnancy and Breastfeeding Warnings

Brand names: Egaten

Triclabendazole Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned.

Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk.

Animal studies have failed to reveal evidence of embryofetal toxicity except associated with maternal toxicity. No malformations were seen in rats and rabbits at doses up to 200 mg/kg/day and 20 mg/kg/day, respectively (about 1.6 times and 0.3 times the maximum recommended human dose based on body surface area comparison, respectively); no increase in malformation or other abnormalities was noted at any dose level in either species. Maternal toxicity was observed at doses at least 100 mg/kg/day (rats) and 10 mg/kg/day (rabbits); associated lower fetus weights and delayed ossification were considered indicative of delayed physiological growth secondary to maternal toxicity. 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.

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Triclabendazole Breastfeeding Warnings

Benefit should outweigh risk.

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

Comments:
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.

See references

Further information

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

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