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Miglitol Pregnancy and Breastfeeding Warnings

Miglitol is also known as: Glyset

Miglitol Pregnancy Warnings

FDA pregnancy category: B Use of miglitol is not recommended unless clearly needed.

Fetotoxicity was indicated by a slight but significant reduction in fetal weight in rats given 450 mg/kg, and a slight reduction in fetal weight, delayed ossification of the fetal skeleton, and an increase in the percentage of nonviable fetuses in rabbits given 200 mg/kg (12 and 10 times the maximum recommended human dose based on body surface area, respectively). These studies revealed no evidence of fetal malformations. There are no controlled data in human pregnancy. FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Miglitol Breastfeeding Warnings

Following a 100 mg maternal dose, total excretion into milk accounted for 0.02% with an estimated exposure of 0.4% of the maternal dose to the nursing infant.

Use of miglitol is not recommended. Excreted into human milk: Yes Excreted into animal milk: Unknown The effects in the nursing infant are unknown.

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