Use is contraindicated

AU TGA pregnancy category: C
FDA pregnancy category: X

Comments:
-Ergotamine may cause fetal harm; if used during pregnancy or pregnancy occurs while taking this drug, the patient should be apprised of the potential hazards to the fetus.

There are no studies on the placental transfer or teratogenicity of the combine products in this drug. Caffeine is known to cross the placenta and has been shown to be teratogenic in animals. Ergotamine crosses the placenta in small amounts, although not enough to be embryotoxic. Prolonged vasoconstriction of uterine vessels and/or increased myometrial tone may lead to reduced myometrial and placental blood flow which may have account for the fetal growth retardation that has been observed in animal studies. This drug should not be used during labor and delivery due to its oxytocic effect which is maximal in the third trimester. There are no controlled studies 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

Ergotamine is excreted in human breast milk and may cause vomiting, diarrhea, weak pulse, and unstable blood pressure in a nursing infant. Ergot drugs are known to inhibit prolactin although there are no reports of decreased lactation. Mothers with high caffeine intakes have had infants with fussiness, jitteriness, and poor sleep patterns. Some experts feel limiting maternal caffeine intake to 300 mg/day may be a safe level for a nursing infant.

A decision should be made to discontinue breast-feeding or discontinue the drug, considering the importance of the drug to the mother.

Excreted into human milk: Yes (ergotamine); Yes (caffeine)

Comment: This drug should not be used while breastfeeding due to the potential for serious adverse events in nursing infants

See references