Skip to Content

Amifampridine Pregnancy and Breastfeeding Warnings

Amifampridine is also known as: Firdapse, Ruzurgi

Medically reviewed by Drugs.com. Last updated on Feb 1, 2019.

Amifampridine Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk.

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:
-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.

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

Amifampridine Breastfeeding Warnings

Safety has not been established.

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

References for pregnancy information

  1. "Product Information. Firdapse (amifampridine)." Catalyst Pharmaceuticals, Inc., Coral Gables, FL.

References for breastfeeding information

  1. "Product Information. Firdapse (amifampridine)." Catalyst Pharmaceuticals, Inc., Coral Gables, FL.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide