FENOLDOPAM

Fetal Risk Summary

An IV infusion of fenoldopam mesylate, a dopamine D1-like receptor agonist, is indicated for the short-term (up to 48 hours), rapid onset management of severe hypertension. It is a vasodilator, affecting coronary, renal, mesenteric, and peripheral arteries in animals.

Reproduction studies have been conducted in rats and rabbits with oral doses up to 200 mg/kg/day and 25 mg/kg/day, respectively (1). Although maternal toxicity was evident at the highest doses, no evidence of impaired fertility or fetal harm were observed.

It is not known if fenoldopam mesylate crosses the human placenta. The molecular weight (about 402) is low enough, however, that transfer to the fetus should be expected.

The absence of human pregnancy experience prevents an assessment of the fetal risk from exposure to fenoldopam mesylate, but the animal data is reassuring. Because it is used for the emergency reduction of severe hypertension, the maternal benefit probably outweighs the unknown fetal risk. However, rapid reduction of maternal blood pressure may compromise the placental perfusion resulting in fetal hypoxia and subsequent bradycardia. Fetal death is a potential consequence of this effect. Fetal heart rate monitoring, therefore, is recommended during IV infusions of fenoldopam.

Breast Feeding Summary

No reports describing the use of fenoldopam mesylate in human lactation have been located. The molecular weight (about 402), however, suggests that excretion into breast milk probably occurs. The effect of this exposure on a nursing infant are unknown. Fenoldopam mesylate is excreted into the milk of lactating rats (1). Because of the nature of the indication, opportunities for use of this drug during breast feeding are probably very rare.

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