Celontin Pregnancy Warnings
Benefit should outweigh risk
US FDA pregnancy category: Not assigned
Risk Summary: There are no available data with this drug in pregnant women to inform a drug-associated risk for major birth defects and miscarriage; anticonvulsant drugs are associated with an elevated incidence of birth defects.
Comments:
-The North American Antiepileptic Drug (NAAED) Pregnancy Registry monitors pregnancy outcomes in women exposed to antiepileptic drugs including this drug; women should be encouraged to enroll by calling toll-free 1-888-233-2334 or visiting the website, http://www.aedpregnancyregistry.org/
Data regarding use of this drug during pregnancy is limited. As with all anticonvulsant drugs, use should not be discontinued when the drug is administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life. In cases where the severity and frequency of seizures are such that stopping the medication does not pose a serious threat, discontinuation may be considered, however, it cannot be said with certainty that even minor seizures don't pose some risk to the developing fetus. There are no controlled data in human pregnancy.
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.
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Celontin Breastfeeding Warnings
Benefit should outweigh risk
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.
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