Pioglitazone in Pregnancy and Breastfeeding
Fetal Risk Summary
Pioglitazone, a thiazolidinedione antidiabetic agent, is used as an adjunct to diet and exercise to improve glycemic control in patients with type II diabetes mellitus. It is used either alone or in combination with other antidiabetic agents (insulin, metformin, or sulfonylureas). Pioglitazone is not an insulin secretagogue, but acts to decrease insulin resistance in the periphery and in the liver (i.e., decreases insulin requirements). Thus, it requires the presence of insulin for its action. Pioglitazone undergoes extensive metabolism by hydroxylation and oxidation, and at least three of the metabolites are pharmacologically active (1).
Reproduction studies with pioglitazone have been conducted in rats and rabbits at doses up to 17 and 40 times, respectively, the maximum recommended human dose on a body surface area basis (MRHD) (1). In pregnant rats, at 10 or more times the MRHD, pioglitazone was embryotoxic as evidenced by increased postimplantation losses, delayed development, and reduced fetal weights. At 2 or more times the MRHD during late gestation and in the lactation period, delayed development was observed that was attributed to decreased body weights. Embryotoxicity was observed in rabbits dosed at 40 times the MRHD (1).
It is not known if pioglitazone or its active metabolites cross the placenta to the fetus. The molecular weight of the parent compound (about 393 for the hydrochloride salt) is low enough, however, that transfer to the fetus should be expected.
No reports describing the use of pioglitazone during human pregnancy have been located. Insulin is the treatment of choice for pregnant diabetic patients because, in general, other hypoglycemic agents do not provide adequate glycemic control. Moreover, insulin, unlike most oral agents, does not cross the placenta to the fetus, thus eliminating the additional concern that the drug therapy itself will adversely effect the fetus. Carefully prescribed insulin therapy provides better control of the mother's glucose, thereby preventing the fetal and neonatal complications that occur with this disease. High maternal glucose levels, as may occur in diabetes mellitus, are closely associated with a number of maternal and fetal adverse effects, including fetal structural anomalies if the hyperglycemia occurs early in gestation. To prevent this toxicity, most experts, including the American College of Obstetricians and Gynecologists, recommend that insulin be used for types I and II diabetes occurring during pregnancy and, if diet therapy alone is not successful, for gestational diabetes (2,3).
Breast Feeding Summary
No reports describing the use of pioglitazone during human lactation have been located. The molecular weight of pioglitazone (about 393 for the hydrochloride salt) is low enough, however, that secretion into breast milk should be expected. Pioglitazone has been detected in the milk of lactating rats (1). In addition, at least three active metabolites have been identified and these also may be transferred into milk. The effects on a nursing infant from exposure to the drug in milk are unknown.
- Product information. Actos. Takeda Pharmaceuticals America, 2000.
- American College of Obstetricians and Gynecologists. Diabetes and pregnancy. Technical Bulletin. No. 200, December 1994.
Coustan DR. Management of gestational diabetes. Clin Obstet Gynecol 1991;34:55864.
Questions and Answers
I use pioglitazone tablets., I get constipation and gas trouble, Anyone suggests remed y?, I wish to continue pioglitazone, as it controls my blood sugar well.
take a laxitive as well. and some beeno
where can i find sites with research work on pioglitazone&its side effects on the liver or kidney?,
Google - Never lets you down!
That or Wikipedia! Wikipedia does all my homework for me!
Why is there no generic form of Actos (Pioglitazone HCl)?, I see that a U.S. federal judge ruled on February 21, 2006 in favor of Takeda Pharmaceuticals North America, Inc. that a patent
covering the active ingredient of ACTOS is valid and enforceable through 2011. Yet this drug has been on the market since 1999 and has generated billions of dollars in profit but yet probably only cost them a billion dollars tops to get to market.
Why am I, under a typical insurance plan, paying $5 per pill (day) because it is a Brand name drug rather than $20 copay for generics. This is obsurd given that 30 million perscriptions have been written for this drug and that 20 million Americans have diabetes.
Does anyone know how they were able to renew this patent which is not typical? Does anyone know of a reliable foreign online pharmacy that sells Pioglitazone?
The patent wasn't extended, it was enforced. It was a lawsuit against several companies who were applying for abbreviated new drug applications. ANDA's are "application that contains information to show that the proposed product is identical in active ingredient, dosage form, strength, route of administration, labeling, quality, performance characteristics and intended use, among other things to a previously approved application (the reference listed drug (RLD). ANDAs do not contain clinical studies as required in NDAs but are required to contain information establishing bioequivalence to the RLD. In general, the bioequivalence determination allows the ANDA to rely on the agency’s finding of safety and efficacy for the RLD." (fda.gov) The court ruled that the patent stands. A patent generally last 17-20 years. You can read more about patents here...http://www4.law.cornell.edu/uscode/html/...
I think it's ridiculous too. Unfortunately that's the way it is...the drug companies get richer and we get poorer. Diabetes itself is one big business.
Pioglitazone pills?, If a normal healthy person takes pioglitazone pills just for the effect of channeling visceral fat into subcutaneous fat, would that be risky in regards to increasing risk to that healthy person to develop diabetes?
the person wont develop diabetes as such with this, but the pill is known to cause several liver related problems .Also the role of channelisn fat in said way is not a clinically documented one,, so take care doin something without medical advise.
anyone have any experience of pioglitazone hydrochloride tablets?, trade name actos it is one of the newer anti diabetic tablets on the market;my g.p. put me on them after i said that stress was driving my sugar high and asked to be signed off and of course she didn't listen;i feel bad on them and notice that weight gain is one of hte side effects;i wonder if the bad feeling is due to anythign other than too low sugar?
I was on 10mg actos and moved up to 30mg actoswithin 3 months, and taken with your diabetic medication such as metaglip, insulin, glucotrol, glucofage?, or whatever, it is supposed to make you more suseptable to your sugar lowering meds. I agree it does mess with you in some ways, but it does help me somewhat, but you may need to be put on a lower dosage (10mg or less) or taken off altogether, get a 2nd doctors opinion.
About Pioglitazone?, one of my friends is recently diagnosed to be diabetic.He receives treatment in the form of pioglitazone and glucophage.His blood sugar became controlled in 2 months of treatment.His only complaint is dizziness not accompanied with any other symptom or sign of hypoglycaemia.This complaint is not related to periods of fasting or to meals.What is the best management of this complaint taking into consideration that this patient doesn't suffer from any other disease after full systematic review.
The pioglitazone has sensitized his cells to the insulin and the metformin is limiting the release of glucose from the liver and also helping with the sensitising aspect. The risk of running normal blood glucose levels at all times, is hypoglycemia. Test the blood glucose at times of dizziness and assure yourself of the levels. Hypoglycemic symptoms are not severe in well controlled cases, but when the brain is not receiving enough glucose, you can expect only dizziness.
What is pioglitazone?,
Generic name for Actos, an oral diabetic medication.
what is pioglitazone hci & metformin hci?, this is a mediceine that has been prescribed without knowledge
it is an oral hypoglycemic agents , used in non-insulin dependent diabetes