PRAVASTATIN

Fetal Risk Summary

Pravastatin is used to lower elevated levels of cholesterol. It has the same cholesterol-lowering mechanism (i.e., inhibition of hepatic 3-hydroxy-3-methylglutaryl-coenzyme A [HMG-CoA] reductase) as some other agents in this class (e.g., see Fluvastatin, Lovastatin, and Simvastatin) and is structurally related to Lovastatin and Simvastatin.

Pravastatin was not teratogenic in rats and rabbits administered doses up to 240 times and 20 times, respectively, the human exposure based on surface area (HE) (1). Similarly, no adverse effects on fertility or reproductive performance were observed in rats with doses up to 120 times the HE (1).

No published reports describing the use of pravastatin during human pregnancy have been located. The Food and Drug Administration has received a single report of a fetal loss in a mother taking pravastatin, but further details are not available (F. Rosa, personal communication, FDA, 1995).

Because the interruption of cholesterol-lowering therapy during pregnancy should have no effect on the long-term treatment of hyperlipidemia, and because of the human data reported with another inhibitor of HMG-CoA reductase (see Lovastatin), the use of pravastatin is contraindicated during pregnancy.

Breast Feeding Summary

No reports describing the use of pravastatin during lactation have been located. The manufacturer reports that pravastatin is excreted into breast milk in small amounts (1). Because of the potential for adverse effects in the nursing infant, the drug should not be used during lactation.

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