Thiola ec Pregnancy Warnings
Use is not recommended.
US FDA pregnancy category: Not assigned.
Risk Summary: Available data with this drug have not identified a risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes.
Comments:
-High doses of this drug in animal studies has been shown to interfere with maintenance of pregnancy and viability of the fetus.
-Adequate methods of contraception should be encouraged.
-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.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-Renal stones in pregnancy may increase the risk of adverse pregnancy outcomes, such as preterm birth and low birth weight.
No findings of fetal malformations could be attributed to this drug in reproduction studies in mice and rats at doses up to 2 times the highest recommended human dose. There are no controlled data in human pregnancy.
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.
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Thiola ec Breastfeeding Warnings
Use is not recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Unknown
Comments:
-The effects in the nursing infant are unknown.
-This drug may suppress milk production.
-Because of the potential for serious adverse reactions, including nephrotic syndrome, breastfeeding is not recommended during therapy with this drug.
See references
