Epinephrine ophthalmic Pregnancy and Breastfeeding Warnings

Brand names: Epifrin, Epinal, Eppy/N, Glaucon

Epinephrine ophthalmic Pregnancy Warnings

Epinephrine has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of teratogenicity when epinephrine was given in doses approximately 25 times the usual recommended human dose (on a per kg basis). There are no reports of teratogenicity in humans. There are no controlled data from human pregnancy. Epinephrine ophthalmic is only recommended for use during pregnancy when benefit outweighs risk.

Because epinephrine is an endogenous catecholamine its relationship to adverse pregnancy outcomes is difficult to determine. Moreover, it is usually only used in dire situations that may otherwise portend fetal risk, such as shock, allergic reactions, and severe bronchial asthma.

Epinephrine crosses the human placenta and may, in high concentrations, cause both maternal and fetal glycogenolysis and elevated blood glucose concentrations. Animal data indicate that epinephrine may cause decreased placental blood flow, increasing the risk of fetal hypoxemia. There has been an interesting debate in the medical literature as to whether endogenous epinephrine and other vasoactive substances play an etiologic role in placental insufficiency, preeclampsia or toxemia of pregnancy.

Data from the Collaborative Perinatal Project (CPP), in which 50,282 mother-child pairs were retrospectively examined, reveal a survival- and race-standardized relative risk for any malformation associated with epinephrine and any sympathomimetic agent of 1.99 and 1.30, respectively. These data are based on an incidence of 22 malformed children from 189 cases (of the 50,282 pairs) where there was first trimester exposures to epinephrine. These data reveal evidence of an association between the use of epinephrine and congenital malformations, although underlying diseases were not accounted for in the analysis.

Data from the Michigan Medicaid Birth Defects Study (MMBDS) reveal no evidence of an association between the use of epinephrine and congenital malformations (written communication, Franz Rosa, MD, Food and Drug Administration, 1994). The MMBDS is a retrospective study of 229,101 deliveries between 1985 and 1992. Of the 229,101 deliveries, 35 were exposed to epinephrine during the first trimester. No defects were observed.

Epinephrine has been extensively and safely used to prolong the analgesic effect of epidurally administered local anesthetics during human pregnancy.

In vitro data have shown that epinephrine increases placental lactate production and increases placental glycogenolysis. While some in vitro data have shown that epinephrine stimulates the spontaneous contractile activity of the nonpregnant uterus, in vivo data have shown that the drug may inhibit uterine contractions and prolong the first stage of labor.

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