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Diazepam Pregnancy and Breastfeeding Warnings

Diazepam is also known as: Diastat, Diastat AcuDial, Diastat Pediatric, Diazepam Intensol, Dizac, Valium, Valrelease, Zetran

Diazepam Pregnancy Warnings

Animal models have revealed evidence of teratogenicity, decreased number of pregnancies, lower surviving offspring numbers, and long-term changes in cellular immune responses, brain neurochemistry, and behavior. Cleft palate, central nervous system malformations/encephalopathy, and permanent functional disturbances occurred in animal models at maternally toxic doses. Neonatal flaccidity, respiratory/feeding difficulties, and hypothermia have been reported in humans. Use during the first and third trimesters may be associated with an increased risk of teratogenicity and withdrawal symptoms in the newborn, respectively. Human data and animal models have revealed evidence of possible genotoxicity. Aneuploidy was induced in men at doses of 10 mg/m2/day. To monitor maternal-fetal outcome of pregnant women exposed to antiepileptic drugs, an Antiepileptic Drug (AED) Pregnancy Registry has been established. Healthcare providers are encouraged to prospectively register patients. For additional information: 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.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. 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 single 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.

See references

Diazepam Breastfeeding Warnings

The milk to plasma ratio ranged between 0.2 and 2.7. This drug may accumulate in breastfed infants, especially with repeated dosing or with acute use of rectal gel formulations.

Use is not recommended and 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: Yes Comment: Sedation, weight loss, and feeding difficulties have occurred in nursing infants.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Valium (diazepam)." Roche Laboratories, Nutley, NJ.
  4. "Product Information. Diastat (diazepam)." Athena Neurosciences Inc, South San Francisco, CA.
  5. "Product Information. Dizac (diazepam)." Ohmeda Pharmaceutical Products Division, Liberty Corner, NJ.

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):
  2. "Product Information. Diastat (diazepam)." Athena Neurosciences Inc, South San Francisco, CA.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Valium (diazepam)." Roche Laboratories, Nutley, NJ.
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  6. "Product Information. Dizac (diazepam)." Ohmeda Pharmaceutical Products Division, Liberty Corner, NJ.

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