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Clobazam Pregnancy and Breastfeeding Warnings

Clobazam is also known as: Onfi, Sympazan

Medically reviewed by Drugs.com. Last updated on Jan 5, 2021.

Clobazam 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.

To monitor maternal-fetal outcome of pregnant women exposed to antiepileptic drugs, the North American Antiepileptic Drug (AED) Pregnancy Registry has been established. Healthcare providers are encouraged to prospectively register patients. For additional information: http://www.aedpregnancyregistry.org/

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.

This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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

Risk summary: This drug may increase the risk of fetal malformations and/or withdrawal symptoms.

Comments:
-Some authorities state that use is contraindicated in the first trimester. Use is not recommended unless clearly needed in the second and third trimesters; however, other experts recommend that use is contraindicated throughout pregnancy.
-If this drug is prescribed to patients of childbearing potential, patients should be warned to contact their physician regarding discontinuation if they intend to become pregnant or are pregnant.
-Some authorities recommend that use of adequate methods of contraception should be encouraged in patients of childbearing potential.
-This drug crosses the placenta and may cause hypotonia, reduced respiratory function, respiratory depression (including respiratory distress and apnea), hypothermia, and feeding difficulties ("floppy infant syndrome") in the newborn. Continuous treatment during pregnancy and administration of high doses in connection with delivery should be avoided. Withdrawal symptoms in newborn infants have been reported.
-If use of this drug is required during pregnancy, patients should be given the lowest effective dose for the shortest possible time. Infants exposed to this drug in utero should be monitored appropriately in the postnatal period.
-A pregnancy exposure registry is available.

See references

Clobazam Breastfeeding Warnings

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

Comments:
-Some authorities state that use is contraindicated.
-Neonates are more susceptible to the toxic effects of benzodiazepines.
-Short-term use is not believed to cause adverse events in breastfed infants, especially those over 2 months of age.
-Long-term administration may cause drowsiness and feeding difficulties in the infant; breastfed infants should be monitored for sedation and poor sucking.

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. Onfi (clobazam)." Lundbeck Inc, Deerfield, IL.
  4. "Product Information. Frisium (clobazam)." Sanofi-Aventis, Laval, IN.

References for breastfeeding information

  1. "Product Information. Frisium (clobazam)." Sanofi-Aventis, Laval, IN.
  2. 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 -]):
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. "Product Information. Onfi (clobazam)." Lundbeck Inc, Deerfield, IL.

Further information

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