Stiripentol Pregnancy and Breastfeeding Warnings

Brand names: Diacomit

Medically reviewed by Drugs.com. Last updated on Sep 19, 2022.

Stiripentol Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed and the benefit outweighs the risk to the fetus; caution is recommended.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned.

Risk summary: No adequate data available on the developmental risks associated with use of this drug in pregnant women.

Comments:
-A pregnancy exposure registry is available.
-According to some authorities: Use of adequate methods of contraception should be encouraged.

Animal studies have revealed evidence of developmental toxicity, including fetal malformations, embryofetal lethality, and embryofetal toxicity. Oral doses (up to 800 mg/kg/day) were administered to pregnant mice and rabbits during organogenesis and to rats during pregnancy and lactation. In mice, increased embryofetal mortality and decreased fetal body weights were observed at all doses and increased incidence of malformations was seen at the high dose (no evidence of maternal toxicity). In rabbits, increased embryofetal mortality was observed at the mid and high dose (associated with maternal toxicity) and decreased fetal body weights were seen at all doses. In rats, decreased pup survival, decreased pup body weights at birth (and through lactation), and deficits in pup reflex development were observed at the high dose (associated with maternal toxicity). The lowest effect dose for developmental toxicity in mice and rabbits (50 mg/kg/day) and the no-effect dose for pre- and postnatal developmental toxicity in rats (200 mg/kg/day) were less than the recommended human dose of 50 mg/kg/day on a mg/m2 basis. This drug and/or its metabolites cross the placenta in rats. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to antiepileptic drugs, the North American Antiepileptic Drug Pregnancy Registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-888-233-2334. For additional information: aedpregnancyregistry.org

In the offspring of women with epilepsy, the prevalence of malformations has been shown at 2 to 3 times greater than reported in the general population. Although other factors (e.g., the epilepsy) can contribute, available evidence suggest that this increase (to a large extent) is caused by the treatment; an increase in malformations has been seen with polytherapy. However, effective antiepileptic therapy should not be interrupted during pregnancy as exacerbation of epilepsy may be harmful to the mother and fetus.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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.

See references

Stiripentol Breastfeeding Warnings

An alternate drug may be preferred, particularly while breastfeeding newborn or preterm infants.
-According to some authorities: Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-No information is available on the use of this drug during breastfeeding.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential adverse effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
-If this drug is continued during breastfeeding, the nursing infant should be carefully monitored for potential adverse effects.

See references

Further information

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