Cysteamine Pregnancy and Breastfeeding Warnings

Brand names: Cystagon, Procysbi

Medically reviewed by Drugs.com. Last updated on Feb 21, 2025.

Cysteamine Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.
-According to some authorities: Use should be avoided during the first trimesters of pregnancy; use is not recommended unless clearly needed.

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

Risk summary: Based on animal data, this drug may cause fetal harm; animal studies have revealed evidence of fetotoxicity at clinically relevant doses.

Comments:
-If a pregnancy is diagnosed or planned, the treatment should be carefully reconsidered, and the patient must be advised of the possible teratogenic risks.

Studies in animals have shown reproductive toxicity, including teratogenesis and fetotoxicity at doses less than the recommended human maintenance dose. Observed teratogenic findings were cleft palate, kyphosis, heart ventricular septal defects, microcephaly, and exencephaly. There are no adequate and well controlled studies in pregnant women.

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

Cysteamine Breastfeeding Warnings

UK: Use is contraindicated.
US: Use is not recommended.

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

This drug reduced the survival of the offspring of adult rats dosed orally with 375 mg/kg/day (1.5 times the maximum recommended human dose based on body surface area).

See references

Further information

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