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General Pregnancy Information
Caffeine-ergotamine has been assigned to pregnancy category X by the FDA. There are no studies on the placental transfer or teratogenicity of the combined product caffeine-ergotamine. Caffeine has been reported to cross the placenta and to be teratogenic in animals. Ergotamine crosses the placenta in small amounts but has not appeared to be embryotoxic in this quantity. However, prolonged vasoconstriction of the uterine vessels and/or increased myocardial tone leading to reduced myometrial and placental blood flow may have contributed to fetal growth retardation observed in animals. There are no controlled data in human pregnancy. Caffeine-ergotamine use is considered contraindicated during pregnancy.
The FDA-assigned pregnancy categories as used in the Drug Formulary
are as follows:
Category A
Adequate and well-controlled studies have failed to demonstrate a risk
to the fetus in the first trimester of pregnancy (and there is no evidence
of risk in later trimesters).
Category B
Animal reproduction studies have failed to demonstrate a risk to the
fetus and there are no adequate and well-controlled studies in pregnant
women.
Category C
Animal reproduction studies have shown an adverse effect on the fetus
and there are no adequate and well-controlled studies in humans, but
potential benefits may warrant use of the drug in pregnant women
despite potential risks.
Category D
There is positive evidence of human fetal risk based on adverse
reaction data from investigational or marketing experience or studies
in humans, but potential benefits may warrant use of the drug in
pregnant women despite potential risks.
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.
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