Ziconotide Pregnancy and Breastfeeding Warnings

Brand names: Prialt

Ziconotide Pregnancy Warnings

Benefit should outweigh risk

US FDA pregnancy category: C

Comments: Animal studies with high doses suggest risk; there is a lack of data on the use of this drug in human pregnancy.

Studies in rats have revealed evidence of embryolethality at doses approximately 700-fold the expected maximum recommended human daily intrathecal dose. Pre and post-natal rat studies did not show affects in pup development or reproductive performance in doses up to 3800-fold higher than expected exposure from the maximum recommended human intrathecal daily dose. Maternal toxicity was observed. 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.

See references

Ziconotide Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comments: This drug is not recommended in nursing infants due to the potential for serious adverse reactions

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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