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Midazolam Pregnancy and Breastfeeding Warnings

Midazolam is also known as: Versed

Medically reviewed on November 29, 2016

Midazolam Pregnancy Warnings

This drug is only recommended for use during pregnancy when there are no alternatives and the benefit outweighs the risk.

AU TGA pregnancy category: C
US FDA pregnancy category: D

Comments:
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Neonates exposed to this drug in the last weeks of pregnancy or in high doses during labor and delivery should be monitored for irregularities in fetal heart rate, hypotonia, poor sucking, hypothermia, and moderate respiratory depression.
-If used during pregnancy, monitor the newborn for acute withdrawal syndrome symptoms during the postnatal period.

Human studies suggest that benzodiazepine-associated teratogenicity and congenital malformations could occur with use. There are no data on exposed pregnancies during the first 2 trimesters, and use during the third trimester could affect brain development.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Midazolam Breastfeeding Warnings

In a small study (n=5), breastfed infants, whose mothers were given a single, 2 mg IV dose were predicted to receive 0.06% of a maternal weight-adjusted dose.

Caution is recommended.

Excreted into human milk: Yes

Comments:
-This drug has been used acutely without apparent harmful effects in the nursing infant.
-Some experts recommend waiting at least 4 hours after a single IV dose to breastfeed.
-The American Academy of Pediatrics states that this is a drug "whose effect on nursing infants is unknown but may be of concern" with prolonged exposure.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Versed (midazolam)." Roche Laboratories, Nutley, NJ.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  4. "Product Information. Versed (midazolam)." Roche Laboratories, Nutley, NJ.

Further information

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

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