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Sodium phenylbutyrate Pregnancy and Breastfeeding Warnings

Sodium phenylbutyrate is also known as: Buphenyl

Medically reviewed by Drugs.com. Last updated on Jul 6, 2021.

Sodium phenylbutyrate Pregnancy Warnings

Not recommended

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Risk Summary: Safety of this drug in human pregnancy is unknown; animal reproduction studies have not been conducted.

Comments:
-Advise women of reproductive potential to use effective contraception.
-Some authorities contraindicate use of this drug during pregnancy.

Animal studies in rats to the active metabolite phenylacetic acid during pregnancy or early postnatal life have been associated with reduced fetal brain weight, impaired performance in learning and memory tasks and neuroanatomical deficits. There are no controlled data in human pregnancy.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain 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

Sodium phenylbutyrate Breastfeeding Warnings

Rat pups administered high doses of phenylacetate (190 to 474 mg/kg) subcutaneously showed decreased proliferation and increased loss of neurons, as well as a reduction in CNS myelin. Cerebral synapse maturation was retarded and the number of functioning nerve terminals in the cerebrum was reduced, resulting in impaired brain growth.

Not recommended

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-Some authorities contraindicate use of this drug during breastfeeding due to potential risk to breastfed infant.

See references

References for pregnancy information

  1. "Product Information. Buphenyl (sodium phenylbutyrate)." Horizon Pharma USA Inc, Northbrook, IL.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. "Product Information. Buphenyl (sodium phenylbutyrate)." Horizon Pharma USA Inc, Northbrook, IL.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

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