Fenfluramine Pregnancy and Breastfeeding Warnings

Brand names: Fintepla, Pondimin

Medically reviewed by Drugs.com. Last updated on Jan 31, 2025.

Fenfluramine Pregnancy Warnings

Safety has not been established.
-Some authorities advise to avoid during pregnancy and in women of childbearing potential not using contraception.

AU TGA pregnancy category: D

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.
-No effects on human fertility up to clinical doses (104 mg/day) were noted. However, animal studies suggest that this drug may possibly affect male and female fertility.

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.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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

Fenfluramine Breastfeeding Warnings

Safety has not been established
-According to some authorities, use is contraindicated while breastfeeding.

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.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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