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Norepinephrine Pregnancy and Breastfeeding Warnings

Norepinephrine is also known as: Levophed, Levophed Bitartrate

Norepinephrine Pregnancy Warnings

Because norepinephrine (NE) 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. Some experts do not advocate the use of NE during pregnancy except in life-threatening situations. In the case of hypotension associated with anesthesia during pregnancy, some experts recommend ephedrine. In other situations in which a vasopressor is needed to treat life-threatening hypotension, a more effective agent such as dopamine is considered the drug of choice. NE crosses and is metabolized by the human placenta. In vitro data have shown that 12% of a radiolabeled dose of NE appears in the fetal blood. Data regarding a similar compound, epinephrine, have shown that, in high concentrations, the drug can cause both maternal and fetal glycogenolysis and elevated blood glucose concentrations. An increased frequency of uterine contractions has been associated with NE. 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 catecholamines play an etiologic role in placental insufficiency, preeclampsia or toxemia of pregnancy. Two retrospective studies are available regarding epinephrine. Data from the Collaborative Perinatal Project (CPP) revealed an overall hospital-standardized relative risk for any malformation associated with epinephrine of 1.71. The CPP retrospectively reviewed 189 cases of first trimester exposure to epinephrine among 50,282 mother-child pairs, and found an incidence of malformations of 22 of 189. When the entire gestational period was studied, 11 malformed children were observed (9.85 were expected) from 508 users of epinephrine. The standardized relative risk of malformations associated with the use of epinephrine used anytime during pregnancy was 1.12. 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. The second study, the Michigan Medicaid Birth Defects Study (MMBDS) revealed no evidence of an association between the use of epinephrine and congenital malformations (written communications, Franz Rosa, 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.

Norepinephrine has been assigned to pregnancy category C by the FDA. Neither animal reproduction studies nor controlled human pregnancy studies are available. Norepinephrine should only be given during pregnancy when benefit outweighs risk.

Norepinephrine Breastfeeding Warnings

There are no data on the excretion of norepinephrine into human milk. A similar compound, epinephrine is known to be excreted into human milk. Because of the potential for serious adverse effects in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

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