Firdapse Pregnancy Warnings
This drug should be used during pregnancy only if the benefit outweighs the risk.
-According to some authorities: This drug should not be used during pregnancy.
US FDA pregnancy category: Not assigned.
Risk Summary: In animal studies, administration of this drug during pregnancy resulted in developmental toxicity (increase in stillbirths and pup deaths, reduced pup weight, and delayed sexual development) at doses associated with maternal plasma drug levels lower than therapeutic drug levels.
Comments:
-A pregnancy exposure registry is available.
-Adequate methods of contraception should be encouraged.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
Animal studies have revealed evidence of embryotoxicity. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.
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 by visiting the study website www.firdapsepregnancystudy.com.
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
Firdapse Breastfeeding Warnings
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the benefit of breast feeding for the child and the benefit of therapy for the mother.
Excreted into human milk: Unknown
Excreted into animal milk: Yes (reaching levels similar to those in maternal plasma)
Comments:
-The effects in the nursing infant are unknown.
-In animal studies, administration of this drug during lactation resulted in developmental toxicity at doses associated with maternal plasma drug levels lower than therapeutic drug levels.
See references
