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Lisdexamfetamine Pregnancy and Breastfeeding Warnings

Lisdexamfetamine is also known as: Vyvanse

Lisdexamfetamine Pregnancy Warnings

Lisdexamfetamine has been assigned to category C by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Lisdexamfetamine is only recommended for use during pregnancy when benefit outweighs risk.

Animal reproduction studies of lisdexamfetamine dimesylate have not been performed. Studies have been performed with the active metabolite of lisdexamfetamine, d-amphetamine, either alone or in combination with l-amphetamine. Animal studies with dextroamphetamine have revealed evidence of embryotoxicity and teratogenicity. In addition, there has been one report of a case of severe congenital bony deformity, tracheoesophageal fistula, and anal atresia (vater association) in a baby born to a woman using dextroamphetamine with lovastatin during the first trimester of pregnancy. Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight. These infants may experience symptoms of withdrawal including dysphoria, agitation, weakness, and exhaustion. One study on the affects of methamphetamine abuse on pregnancy outcome reported that body weight, length, and head circumference were significantly decreased in neonates born to mothers who abused methamphetamines during pregnancy. The study also noted that the frequency of congenital anomalies was not significantly increased.

Lisdexamfetamine Breastfeeding Warnings

Amphetamines are excreted into human milk. According to the manufacturer, breast-feeding is not recommended during administration of lisdexamfetamine.

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