Oseni and Pregnancy
It is unknown whether it is safe for women to take Oseni (alogliptin and pioglitazone) during pregnancy. Animal studies on this medication showed that the individual components increased the risk for miscarriage, low fetal weights, and delayed development. If you are pregnant or thinking of becoming pregnant, talk to your healthcare provider about whether Oseni is right for you.
Oseni® (alogliptin and pioglitazone) is a medication that contains two prescription diabetes medications: pioglitazone (Actos®) and alogliptin (Nesina®). Oseni may not be safe for use during pregnancy; however, the full risks are unknown.
The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Oseni is classified as a pregnancy Category C medicine.
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.
Oseni has not been studied in pregnant women. In animal studies, pioglitazone, one of the active ingredients in it, did not appear to increase the risk for birth defects when given to pregnant rats and rabbits, even in large doses. The drug did, however, increase the risk for miscarriage in the pregnant rats. It also caused delayed development and lowered the body weight of the fetal rats.
Alogliptin, the other active ingredient in Oseni, did not cause birth defects or other problems when given to pregnant rats and rabbits, even at very high doses. When the combination of alogliptin and pioglitazone was given to pregnant rats, it added slightly to the delayed development and reduced fetal weight observed with pioglitazone alone.
It is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.
If you have diabetes and are pregnant or thinking of becoming pregnant, you should work closely with your healthcare provider to ensure your blood sugar levels are well controlled. Poor blood glucose control during pregnancy can harm you and your baby. This includes the early period of pregnancy, before many women know they are pregnant.