Actos and Pregnancy
There are many possible side effects that can occur during treatment with Actos, and pregnancy complications are a potential risk. During studies of pregnant animals, Actos was shown to cause miscarriages and slow the growth of fetuses. The U.S. Food and Drug Administration has classified Actos as a pregnancy Category C medicine, which means it should be prescribed only if a healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.
For women who are pregnant, Actos® (pioglitazone hydrochloride) may not be safe. This is based on animal studies that looked at the effects of Actos during pregnancy.
The U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medicines that have not been studied in pregnant humans but do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Actos was given a pregnancy Category C rating based on studies in pregnant animals. Large doses of Actos given to pregnant rats increased the risk of miscarriages and slowed the growth of the fetal rats. Actos did not increase the risk of birth defects.
It is important to note that animals do not always respond to medicines the same way that humans do. Therefore, a pregnancy Category C medicine may be given to pregnant women if the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.