Pirfenidone Pregnancy and Breastfeeding Warnings

Brand names: Esbriet

Medically reviewed by Drugs.com. Last updated on Aug 18, 2023.

Pirfenidone Pregnancy Warnings

Use should be avoided.

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

Comments:
-Data on use in pregnant patients is insufficient to inform on drug associated risks for major birth defects and miscarriage.
-Animal studies did not show teratogenicity at doses up to 3 times the maximum recommended human dose.

Fertility and embryo-fetal development studies revealed no evidence of impaired fertility or fetal harm in rats and rabbits that received oral doses up to 3 and 2 times, respectively, the maximum recommended daily dose (MRDD) in adults. However, a pre- and post-natal development study showed gestation prolongation, decreased number of live newborns, reduction in fetal viability and lower body weights in rats receiving an oral dosage approximately 3 times the MRDD in adults. Additionally, acyclic/irregular cycles were seen in rats at doses approximately equal to and higher that the MRDD in adults in the presence of maternal toxicity. There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.


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.

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Pirfenidone Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comments:
-Animal studies showed reduced body weight gain in the offspring of animals receiving 300 mg/kg/day or higher during gestation and lactation; a risk to human infants cannot be excluded.
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

See references

Further information

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