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Carglumic acid Pregnancy and Breastfeeding Warnings

Carglumic acid is also known as: Carbaglu

Medically reviewed on May 10, 2018

Carglumic acid Pregnancy Warnings

In animal studies dosed from 2 weeks prior to mating through organogenesis, no effects on embryo-fetal development were observed in pregnant rats receiving approximately 38 times (2000 mg/kg/day) or pregnant rabbits receiving approximately 6 times (1000 mg/kg/day) the maximum human maintenance dose. Among pregnant rats receiving oral drug from organogenesis through lactation, decreased growth of offspring was observed at 500 mg/kg/day and higher, and reduction in offspring survival during lactation was observed at 2000 mg/kg/day. Maternal toxicity described as impaired weight gain and approximately 10% mortality occurred at 2000 mg/kg/day. There are no adequate and well controlled studies in pregnant women.

AU TGA pregnancy category B1: 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 not shown evidence of an increased occurrence of fetal damage.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use is acceptable

AU TGA pregnancy category: B1
US FDA pregnancy category: C

Comments: Women with N-acetylglutamate synthase (NAGS) deficiency must remain on this drug throughout pregnancy as untreated NAGS results in irreversible neurologic damage and death.

See references

Carglumic acid Breastfeeding Warnings

Not recommended

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

Comments: An increase in mortality and impairment of body weight gain has been observed in neonatal rats nursed by mothers receiving this drug.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Carbaglu (carglumic acid)." Accredo Health Group Inc, Memphis, TN.

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Carbaglu (carglumic acid)." Accredo Health Group Inc, Memphis, TN.

Further information

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

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