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Clobazam Pregnancy and Breastfeeding Warnings

Clobazam is also known as: Onfi, Sympazan

Medically reviewed on Aug 6, 2018

Clobazam Pregnancy Warnings

Data from animal studies have indicated possible adverse developmental effects (long-term effects on neurobehavioral and immunological function). There are no controlled data in human pregnancy.

To monitor maternal-fetal outcome of pregnant women exposed to antiepileptic drugs, the North American Antiepileptic Drug (NAAED) 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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
-Some experts recommend: 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.

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

Comments:
-If this drug is prescribed to a woman of childbearing potential, she should be warned to contact her physician regarding discontinuation if she intends to become pregnant or is pregnant.
-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.
-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.
-Some experts recommend: Use is contraindicated.

Excreted into human milk: Yes

Comments:
-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. "Australian Product Information." O 0
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." 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.

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