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Ziconotide Pregnancy and Breastfeeding Warnings

Ziconotide is also known as: Prialt

Ziconotide Pregnancy Warnings

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.

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.

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

References for pregnancy information

  1. "Product Information. Prialt (ziconotide)." Elan Pharmaceutical/Athena Neurosciences Inc, South San Francisco, CA.

References for breastfeeding information

  1. "Product Information. Prialt (ziconotide)." Elan Pharmaceutical/Athena Neurosciences Inc, South San Francisco, CA.

Further information

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

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