Miglitol

The Basics

What is Miglitol?

Used to treat high blood sugar levels that are caused by type 2 diabetes.

Brand names for Miglitol

Glyset

How Miglitol is classified

Hypoglycemic Agents

Miglitol During Pregnancy

Miglitol pregnancy category

Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Miglitol while pregnant

The safety of GLYSET in pregnant women has not been established. Developmental toxicology studies have been performed in rats at doses of 50, 150 and 450 mg/kg, corresponding to levels of approximately 1.5, 4, and 12 times the maximum recommended human exposure based on body surface area. In rabbits, doses of 10, 45, and 200 mg/kg corresponding to levels of approximately 0.5, 3, and 10 times the human exposure were examined. These studies revealed no evidence of fetal malformations attributable to miglitol. Doses of miglitol up to 4 and 3 times the human dose (based on body surface area), for rats and rabbits respectively, did not reveal evidence of impaired fertility or harm to the fetus. The highest doses tested in these studies, 450 mg/kg in the rat and 200 mg/kg in the rabbit promoted maternal and/or fetal toxicity. Fetotoxicity was indicated by a slight but significant reduction in fetal weight in the rat study and slight reduction in fetal weight, delayed ossification of the fetal skeleton and increase in the percentage of non-viable fetuses in the rabbit study. In the peri-postnatal study in rats, the NOAEL (No Observed Adverse Effect Level) was 100 mg/kg (corresponding to approximately four times the exposure to humans, based on body surface area). An increase in stillborn progeny was noted at the high dose (300 mg/kg) in the rat peri-postnatal study, but not at the high dose (450 mg/kg) in the delivery segment of the rat developmental toxicity study. Otherwise, there was no adverse effect on survival, growth, development, behavior, or fertility in either the rat developmental toxicity or peripostnatal studies. There are however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, miglitol should be used during pregnancy only if clearly needed.

Taking Miglitol While Breastfeeding

What are recommendations for lactation if you're taking Miglitol?

Limited data indicate that miglitol is poorly excreted into breastmilk. Because miglitol is also poorly absorbed orally, it is unlikely to adversely affect the breastfed infant.

Maternal / infant drug levels

Limited data indicate that miglitol is poorly excreted into breastmilk. Because miglitol is also poorly absorbed orally, it is unlikely to adversely affect the breastfed infant.

Possible effects of Miglitol on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Miglitol

Acarbose, Glipizide, Glyburide, Insulin, Metformin.