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Riluzole Pregnancy and Breastfeeding Warnings

Riluzole is also known as: Rilutek

Riluzole Pregnancy Warnings

Riluzole has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of embryotoxicity. There are no controlled data in human pregnancy. Riluzole should only be given during pregnancy when benefit outweighs risk.

Animal embryotoxicity has been observed at 2.6 and 11.5 times the recommended maximum human daily dose on a mg/m2 basis. Maternal toxicity was also noted at these doses. Decreased implantations, increased intrauterine death, decreased viability and decreased growth occurred in animal studies at 1.5 times the recommended daily dose on a mg/m2 basis. Impairment of fertility has been noted in animal studies in both the male and the female of the species at 1.5 times the recommended daily dose on a mg/m2 basis.

Riluzole Breastfeeding Warnings

There are no data on the excretion of riluzole into human milk.

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