Qelbree Pregnancy Warnings
Animal data has shown oral administration of this drug to pregnant rats and mice during pregnancy and lactation caused maternal toxicities and deaths at doses approximately 2 and 1 times the maximum recommended human dose based on mg/m2, respectively. Offspring toxicities were observed at these maternally toxic doses. 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 decision and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
Not recommended unless the benefits outweigh the potential risk to the mother
US FDA pregnancy category: Not assigned
Risk Summary: Available data from case series in pregnant women taking this drug are insufficient to determine a drug-associated risk of major birth defects, miscarriage or adverse maternal outcomes; animal data suggests this drug may cause maternal harm.
Comments:
-This drug should be discontinued when pregnancy is recognized unless the benefits of therapy outweigh the potential risk to the mother.
-There is a pregnancy registry that monitors pregnancy outcomes in women exposed to this drug during pregnancy; healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at www.womensmentalhealth.org/preg.
See references
Qelbree Breastfeeding Warnings
There are no data on the presence of this drug in human. According to the manufacturer's product labeling, it is likely this drug is excreted into rat milk and therefore, may be present in human milk.
Benefit should outweigh risk
Excreted into human milk: Unknown
Excreted into animal milk: Unknown (likely)
Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.
See references
