Miglustat Pregnancy and Breastfeeding Warnings

Miglustat is also known as: Zavesca

Miglustat Pregnancy Warnings

Animal studies have revealed evidence of fetal harm, maternal death, and impaired fertility by adversely affecting spermatogenesis and sperm parameters. There are no controlled data in human pregnancy. In 7 healthy men, no effect on sperm level, motility, or morphology was observed. Increased risk of spontaneous abortion in women with type 1 Gaucher disease, especially if disease symptoms are not treated and controlled before conception and during pregnancy. Type 1 Gaucher disease symptoms may worsen or new symptoms may develop due to pregnancy. Such symptoms may lead to adverse pregnancy outcomes. FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

FDA pregnancy category: C Miglustat should be used during pregnancy only if the benefit outweighs the risk to the fetus. Comments: Maternal and embryo/fetal risk due to the mother's underlying condition should be considered.

Miglustat Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Data not available

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