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Clobazam Pregnancy and Breastfeeding Warnings

Clobazam is also known as: Onfi

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. US: To provide information regarding the effects of in utero exposure, physicians are advised to recommend that pregnant patients taking this drug enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves or their caregiver. Information on the registry can also be found at the website 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.

AU: Contraindicated. UK: Contraindicated in the first trimester. Use is not recommended unless clearly needed in the second and third trimesters. US: 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: 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.

Clobazam Breastfeeding Warnings

AU, UK: Use is contraindicated. US: 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: -This drug may cause drowsiness and feeding difficulties in the infant. -Neonates are more susceptible to the toxic effects of benzodiazepines.

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