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Desflurane Pregnancy and Breastfeeding Warnings

Brand names: Suprane

Desflurane Pregnancy Warnings

Animal studies have revealed evidence of increased post-implantation loss, decreased weight, and maternal toxicity. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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.

This drug should be used during pregnancy only if the benefit outweighs the risk.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned.

Risk Summary: In animal reproduction studies this drug caused embryofetal toxicity (reduced viable fetuses and/or increased post-implantation loss) when administered during organogenesis. Published studies in pregnant primates demonstrate that the administration of anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity during the period of peak brain development increases neuronal apoptosis in the developing brain of the offspring when used for longer than 3 hours.

See references

Desflurane Breastfeeding Warnings

Use is not recommended.

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

Comments:
-The effects in the nursing infant are unknown.

There is no published experience with this drug during breastfeeding. Because the serum half-life in the mother is short and the drug is not expected to be absorbed by the infant, no waiting period or discarding of milk is required. Breastfeeding can be resumed as soon as the mother has recovered sufficiently from general anesthesia to nurse. When a combination of anesthetic agents is used for a procedure, follow the recommendations for the most problematic medication used during the procedure.

See references

References for pregnancy information

  1. Product Information. Suprane (desflurane). Baxter Pharmaceutical Products, Inc. 2008.

References for breastfeeding information

  1. Product Information. Suprane (desflurane). Baxter Pharmaceutical Products, Inc. 2008.
  2. United States National Library of Medicine. Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT 2013.

Further information

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