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June 10, 2003

Family Planning, Pills for Diabetes

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Question from Houston, Texas, USA:

My doctor prescribed Actos to help increase my fertility, and I recently discovered I am pregnant (about five and a half weeks). My physician says I must continue taking the Actos throughout my pregnancy, but I am very concerned about the effects on the developing fetus, and I understand that the chance for a miscarriage is decreased by remaining on it. Do the benefits of preventing miscarriage outweigh the possible effects on the baby? Is this safe?

Answer:

From: DTeam Staff

There are some studies with small numbers of women diagnosed with Polycystic Ovary Syndrome who have used an entirely different diabetes pill, Glucophage [metformin], to increase ovulation by decreasing insulin resistance and have continued its use during pregnancy to reduce the incidence of miscarriage. There have not been any reported fetal effects, but, as I stated these are reports on only a few patients.

I am not aware of any data on Actos [pioglitazone]. Therefore, I cannot recommend its use in this fashion. I would suggest speaking to your doctor about using a more standard approach.

OWJ

[Editor’s comment: The US label for Actos states: “Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. ACTOS should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because current information strongly suggests that abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital anomalies, as well as increased neonatal morbidity and mortality, most experts recommend that insulin be used during pregnancy to maintain blood glucose levels as close to normal as possible.”

Actos does not have an approved indication except for use in type 2 diabetes.

WWQ]