Berdazimer topical Pregnancy and Breastfeeding Warnings
Brand names: Zelsuvmi
Berdazimer topical Pregnancy Warnings
Safety has not been established during pregnancy.
US FDA pregnancy category: Not assigned
Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk.
Animal studies have not been reported with the topical use of this drug. Oral administration in rats and rabbits during pregnancy showed increased skeletal and visceral malformations and severe maternal toxicity. 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.
Berdazimer topical Breastfeeding Warnings
Safety has not been established.
Excreted into human milk: Unknown
Excreted into animal milk: Unknown
Comments:
-The effects in the nursing infant are unknown.
-No information is available on the clinical use of this drug during breastfeeding.
-The developmental and health benefits of breastfeeding should be considered, as well as the mother's clinical need for this drug.
See also
References for pregnancy information
- (2024) "Product Information. Zelsuvmi (berdazimer topical)." Ligand Pharmaceuticals
References for breastfeeding information
- (2024) "Product Information. Zelsuvmi (berdazimer topical)." Ligand Pharmaceuticals
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
