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Oxazepam Pregnancy and Breastfeeding Warnings

Oxazepam is also known as: Serax

Medically reviewed on September 28, 2016

Oxazepam Pregnancy Warnings

Several studies have suggested an increased risk of congenital malformations associated with the use of minor tranquilizers (i.e., chlordiazepoxide, diazepam, and meprobamate) during the first trimester of pregnancy. There are no adequate studies in pregnant women.

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 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.

Use should be avoided.

AU TGA pregnancy category: C

US FDA pregnancy category: Not Assigned

Comments:
-The child born to a mother taking benzodiazepines may be at risk for withdrawal symptoms.
-Benzodiazepines may cause fetal harm when administered during pregnancy.
-The patient should be warned of the potential risks to the fetus and instructed to discontinue the drug prior to becoming pregnant.

See references

Oxazepam Breastfeeding Warnings

AU: Caution is recommended.

UK: Use is not recommended.

US: The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Yes

Comments:
-Lethargy and weight loss may occur in breastfed infants.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Serax (oxazepam)." Wyeth-Ayerst Laboratories, Philadelphia, PA.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Serax (oxazepam)." Wyeth-Ayerst Laboratories, Philadelphia, PA.

Further information

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

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