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Caffeine / ergotamine Pregnancy and Breastfeeding Warnings

Caffeine / ergotamine is also known as: Cafatine, Cafergot, Cafetrate, Ercaf, Migergot, Wigraine

Caffeine / ergotamine Pregnancy Warnings

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

Caffeine / ergotamine Breastfeeding Warnings

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

References for pregnancy information

  1. Verloes A, Emonts P, Dubois M, Rigo J, Senterre J "Paraplegia and arthrogryposis multiplex of the lower extremities after intrauterine exposure to ergotamine." J Med Genet 27 (1990): 213-4
  2. Mills JL, Holmes LB, Aarons JH, Simpson JL, Brown ZA, Jovanovic-Peterson LG, Conley MR, Graubard BI, Knopp RH, Metzger BE "Moderate caffeine use and the risk of spontaneous abortion and intrauterine growth retardation [see comments." JAMA 269 (1993): 593-7
  3. Eskenazi B "Caffeine during pregnancy: grounds for concern? [editorial; comment]." JAMA 270 (1993): 2973-4
  4. "Product Information. Bellergal-S (ergotamine)." Sandoz Pharmaceuticals Corporation, East Hanover, NJ.
  5. Joesoef MR, Beral V, Rolfs RT, Aral SO, Cramer DW "Are caffeinated beverages risk factors for delayed conception? [see comments." Lancet 335 (1990): 136-7
  6. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  7. "Product Information. Cafergot (ergotamine)." Sandoz Pharmaceuticals Corporation, East Hanover, NJ.

References for breastfeeding information

  1. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
  2. Roberts RJ, Blumer JL, Gorman RL, et al "American Academy of Pediatrics Committee on Drugs: Transfer of drugs and other chemicals into human milk." Pediatrics 84 (1989): 924-36
  3. "Product Information. Cafergot (ergotamine)." Sandoz Pharmaceuticals Corporation, East Hanover, NJ.
  4. "Product Information. Bellergal-S (ergotamine)." Sandoz Pharmaceuticals Corporation, East Hanover, NJ.
  5. Berlin CM Jr, Denson HM, Daniel CH, Ward RM "Disposition of dietary caffeine in milk, saliva, and plasma of lactating women." Pediatrics 73 (1984): 59-63
  6. Rose JE, Behm FM "Psychophysiological interactions between caffeine and nicotine." Pharmacol Biochem Behav 38 (1991): 333-7

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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