Monomethyl fumarate Pregnancy and Breastfeeding Warnings

Brand names: Bafiertam

Medically reviewed by Drugs.com. Last updated on Nov 7, 2023.

Monomethyl fumarate Pregnancy Warnings

Use should be avoided.

US FDA pregnancy category: Not assigned.

Risk Summary: Animal studies revealed adverse effects on offspring survival, growth, sexual maturation, and neurobehavioral function when this drug was administered during pregnancy at clinically relevant doses.

Comments:
-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-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 increased lethality, persistent reductions in body weight, delayed sexual maturation (male and female pups), reduced testicular weight, neurobehavioral impairment, and maternal toxicity. 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

Monomethyl fumarate Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comments:
-The effects in the nursing infant are unknown.

See references

Further information

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

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