Roflumilast Pregnancy and Breastfeeding Warnings

Brand names: Daliresp

Medically reviewed by Drugs.com. Last updated on Apr 1, 2024.

Roflumilast Pregnancy Warnings

Animal studies done during organogenesis showed no fetal structural abnormalities, but at 10 times the maximum human dose post-implantation losses increased, and at doses 16 to 49 times the maximum human dose induced stillbirth and decreased pup viability. Post-natal development was adversely affected at 49 times the maximum human dose. 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.

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

Comments:
-This drug disrupted the labor and delivery process in animal studies.
-Do not use this drug during labor and delivery.

See references

Roflumilast Breastfeeding Warnings

Use is not recommended.

Excreted into human milk: Data not available
Excreted into animal milk: Yes

Comments:
-Excretion into human milk is probable.
-Animals given 1 mg/kg of this drug orally had breastmilk concentrations of active drug or its metabolites of 0.32 mcg/gram after 8 hours.

See references

Further information

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