Pravastatin
Risk Factor: XM
Class: ANTILIPEMIC AGENTS
Contents of this page:
Fetal Risk Summary
Breast Feeding Summary
References
Questions and Answers
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.
References
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Product information. Pravachol. Bristol-Myers Squibb, 2000.
Questions and Answers
How long should you be off the cholesterol lowering medicine Pravastatin before trying to get pregnant?
In 89% of the prospectively followed pregnancies, drug treatment was initiated prior to pregnancy and was discontinued at some point in the first trimester when pregnancy was identified. As safety in pregnant women has not been established and there is no apparent benefit to therapy with Pravastatin during pregnancy (see CONTRAINDICATIONS), treatment should be immediately discontinued as soon as pregnancy is recognized. Pravastatin sodium should be administered to women of child-bearing potential only when such patients are highly unlikely to conceive and have been informed of the potential hazard
You should check with your doctor, because this is a very serious question. : )
