Fenfluramine Pregnancy and Breastfeeding Warnings
Brand names: Fintepla, Pondimin
Medically reviewed by Drugs.com. Last updated on Feb 10, 2023.
Fenfluramine Pregnancy Warnings
Safety has not been established.
-Some authorities advise to avoid during pregnancy as a precautionary measure.
US FDA pregnancy category: Not assigned
Risk Summary: There are no adequate human data on the developmental risks associated with the use of this drug in pregnancy.
Comments:
-This drug can cause decreased appetite and decreased weight. If used, monitor for adequate weight gain during pregnancy.
Animal studies, throughout organogenesis (rat and rabbit) or throughout gestation (rat) resulted in adverse effects on development (fetal malformations, embryofetal and offspring mortality and growth impairment) in the presence of maternal toxicity at clinically relevant maternal plasma levels of this drug and its major active metabolite. 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.
Fenfluramine Breastfeeding Warnings
Safety has not been established
Excreted into human milk: Unknown
Excreted into animal milk: Yes (metabolites)
Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Some authorities advise against use while breastfeeding as a risk to the breastfed infant cannot be ruled out.
A lactation study in rats with radiolabeled dexfenfluramine has shown excretion of dexfenfluramine and nordexfenfluramine into rat milk.
See also
References for pregnancy information
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- (2020) "Product Information. Fintepla (fenfluramine)." Zogenix, Inc
- (2023) "Product Information. Fintepla (fenfluramine)." UCB Pharma Ltd, SUPPL-13
References for breastfeeding information
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- (2020) "Product Information. Fintepla (fenfluramine)." Zogenix, Inc
- (2023) "Product Information. Fintepla (fenfluramine)." UCB Pharma Ltd, SUPPL-13
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.