Resmetirom Pregnancy and Breastfeeding Warnings

Brand names: Rezdiffra

Medically reviewed by Drugs.com. Last updated on Apr 15, 2024.

Resmetirom Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: There are no data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-There are risks to the mother and fetus related to underlying noncirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis in pregnancy.
-A pregnancy exposure registry is available.

Animal studies have revealed evidence of adverse effects on embryofetal development. Dose-related increases in post-implantation loss and decreases in viable fetuses and fetal weight were observed when this drug was administered to pregnant rabbits at maternally toxic doses during the period of organogenesis (i.e., 3.5 times the maximum recommended human dose [MRHD] based on AUC). Treatment doses of 37 times the MRHD in female rats showed a decrease in pup birthweight and an increased incidence of stillbirths and postnatal mortality; effects were associated with suppression of maternal thyroid hormones. No adverse developmental effects were observed at lower dose levels in pregnant animals. The metabolite of this drug, MGL-3623, was tested for its effects on embryofetal development and no adverse outcomes were observed. There are no controlled data in human pregnancy.

There are risks to the mother and fetus related to underlying maternal NASH with liver fibrosis, such as increased risks of gestational diabetes, hypertensive complications, preterm birth, and postpartum hemorrhage.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves. For additional information visit Madrigal Pharmaceuticals at https://www.madrigalpharma.com/contact/

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

Resmetirom Breastfeeding Warnings

Safety has not been established.

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

Comments:
-There is no information on the presence of this drug in human milk, the effects on milk production, or the effects on the breastfed infant.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug, as well as any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.

See references

Further information

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