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Bupivacaine liposome Pregnancy and Breastfeeding Warnings

Brand names: Exparel

Medically reviewed by Drugs.com. Last updated on Apr 15, 2024.

Bupivacaine liposome Pregnancy Warnings

Use is not recommended

US FDA pregnancy category: Not assigned.

Risk summary: This drug is not recommended during pregnancy and in women of childbearing potential not using contraception.

Animal studies have revealed evidence of embryofoetal death and decreased pup survival when administered subcutaneously to pregnant rats and rabbits. 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.

See references

Bupivacaine liposome Breastfeeding Warnings

Benefit should outweigh risk.

Excreted into human milk: Yes

Comments:
-There is no information on the effects of this drug in the breastfed infant or on milk production.
-The health benefits of breastfeeding should be considered along with the mother's need for treatment, and any adverse events from this drug both for mother and infant.
-According to some authorities, a decision should be made to discontinue breastfeeding or to discontinue or abstain from treatment with this drug.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. (2011) "Product Information. Exparel (BUPivacaine liposome)." Pacira Pharmaceuticals Inc

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. (2011) "Product Information. Exparel (BUPivacaine liposome)." Pacira Pharmaceuticals Inc

Further information

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