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

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

Comments:
-According to some authorities use during pregnancy is inadvisable due to the absence of data regarding this drug crossing the placental barrier.

Animal studies showed teratogenicity and fetotoxicity when given during organogenesis at subcutaneous doses from 410 to 1640 mg/kg/day. Maternal toxicity and death occurred at 720 mg/kg/day or higher given during organogenesis, as well as pups with impaired reflexes. 510 mg/kg/day was the highest dose tolerated in pregnant rats. There are no controlled data in human pregnancy.


AU Exempt: Medications exempted from pregnancy classification are not absolutely safe for use in pregnancy in all circumstances. Some exempted medicines, for example the complementary medicine, St John's Wort, may interact with other medicines and induce unexpected adverse effects in the mother and/or fetus.

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

Use is not recommended.

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

Comments:
-The low molecular weight (about 182) suggests this drug will appear in milk.
-Use of this drug implies heavy metal poisoning; many heavy metals are excreted in human milk and could lead to toxicity in the child.

See references