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Metformin / pioglitazone Pregnancy and Breastfeeding Warnings

Metformin / pioglitazone is also known as: ActoPlus Met, ActoPlus Met XR

Metformin / pioglitazone Pregnancy Warnings

Use is not recommended; this drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. Comments: Premenopausal anovulatory women may be at risk for pregnancy; these women should be informed of pregnancy risk. US FDA pregnancy category: C

Animal studies using pioglitazone at 10 to 40 times the maximum recommended human dose have shown increased rates of postimplantation loss, delayed development, reduced fetal weights, and delayed parturition. There are no adequate and well-controlled studies in pregnant women. Abnormal blood glucose concentrations during pregnancy are associated with a higher incidence of congenital anomalies, increased neonatal morbidity, and mortality. Most experts recommend insulin use during pregnancy to maintain blood glucose concentrations as close to normal as possible. US 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.

Metformin / pioglitazone Breastfeeding Warnings

UK: Use is contraindicated. US: 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: Yes, in small amounts (metformin); Unknown (pioglitazone) Excreted into animal milk: Yes (metformin); Yes (pioglitazone) Comments: The effects in the nursing infant are unknown.

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