The tissues into which sibutramine usually gets distributed (primarily the liver and kidney) have been unaffected by pregnancy. Relatively low transfer to the fetus has been reported.

Sibutramine has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of maternal toxicity, cardiovascular anomalies, broad short snout, short rounded pinnae, short tail, and shorter thickened long bones in the limbs. There are no adequate controlled data in human pregnancy. The use of sibutramine is considered contraindicated during pregnancy. It is recommended that women of child bearing potential use adequate contraception while on sibutramine therapy. Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy.

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There are no data on the excretion of sibutramine into human milk. Sibutramine is considered contraindicated during breast-feeding by the manufacturer. Patients should be advised to notify their physician if they are breast-feeding.

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