Trudhesa Pregnancy Warnings
Use is contraindicated
AU TGA pregnancy category: C
US FDA pregnancy category: X
Comment:
-This drug should be discontinued immediately if a pregnancy occurs; if used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazards to the fetus.
Animal studies have revealed evidence of developmental toxicity including decreased fetal body weights and/or skeletal ossification, delayed skeletal ossification, and impaired reproductive function (decreased mating indices) in the offspring. These development effects occurred at doses below those producing maternal toxicity. As this drug induces uterine contractions, it may cause premature parturition or hypertonic labor. There are no controlled data in human pregnancy.
AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.
US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
See references
Trudhesa Breastfeeding Warnings
Specific data documenting the concentration of this drug in human breast milk is lacking, but since ergot drugs are known to be excreted in human milk, it is likely this drug is present in breast milk. Potential adverse events in nursing infants may include vomiting, diarrhea, weak pulse, and unstable blood pressure. Ergot drugs are known to inhibit prolactin.
Use is contraindicated
Excreted into human milk: Unknown (probably)
Comment:
-This drug should not be used while breastfeeding due to the potential for serious adverse events in nursing infants.
See references