The Basics

What is Pioglitazone?

Used to treat type 2 diabetes.

Brand names for Pioglitazone

Actos

How Pioglitazone is classified

Hypoglycemic Agents, Thiazolidinediones

Pioglitazone During Pregnancy

Pioglitazone pregnancy category

Category CNote 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 Pioglitazone while pregnant

Pioglitazone was not teratogenic in rats at oral doses up to80 mg/kg or in rabbits given up to 160 mg/kg during organogenesis (approximately 17and 40 times the maximum recommended human oral dose based on mg/m2,respectively). Delayed parturition and embryotoxicity (as evidenced by inceasedpostimplantation losses, delayed development and reduced fetal weights) wereobserved in rats at oral doses of 40 mg/kg/day and above (approximately 10 times themaximum recommended human oral dose based on mg/m2). No functional orbehavioral toxicity was observed in offspring of rats. In rabbits, embryotoxicity wasobserved at an oral dose of 160 mg/kg (approximately 40 times the maximumrecommended human oral dose based on mg/m2). Delayed postnatal development,attributed to decreased body weight, was observed in offspring of rats at oral doses of10 mg/kg and above during late gestation and lactation periods (approximately 2 timesthe maximum recommended human oral dose based on mg/m2).There are no adequate and well-controlled studies in pregnant women. ACTOS shouldbe used during pregnancy only if the potential benefits justifies the potential risk to thefetus.Because current information strongly suggests that abnormal blood glucose levelsduring pregnancy are associated with a higher incidence of congenital anomalies, aswell as increased neonatal morbidity and mortality, most experts recommend that insulin be used during pregnancy to maintain blood glucose levels as close to normal aspossible.

Taking Pioglitazone While Breastfeeding

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

No information is available on the clinical use of pioglitazone during breastfeeding. Pioglitazone is over 99% protein bound in plasma, so it is unlikely to pass into breastmilk in clinically important amounts. However, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Maternal / infant drug levels

No information is available on the clinical use of pioglitazone during breastfeeding. Pioglitazone is over 99% protein bound in plasma, so it is unlikely to pass into breastmilk in clinically important amounts. However, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Possible effects of Pioglitazone on milk supply

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

Possible alternatives to Pioglitazone

Acarbose, Glipizide, Glyburide, Insulin, Metformin, Miglitol.

List of References

Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/None listed

Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.

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