Avapro and Pregnancy
Potential risks to a fetus are associated with Avapro, and pregnancy Category C and D classifications have been given to the drug. Pregnancy Category C means that side effects on a fetus were present in animal studies. Pregnancy Category D means there is clear evidence of risk to a fetus in human studies. Fetal complications associated with Avapro and pregnancy include kidney failure, facial deformities, developmental problems, and loss of life.
For people who are pregnant, Avapro® (irbesartan) is usually not recommended. This is because during pregnancy, Avapro can cause temporary or permanent problems for the unborn child, including death.
Prior to 2006, the belief among healthcare providers was that problems with Avapro and pregnancy were generally seen when the drug was taken during the second or third trimester of pregnancy. However, that changed when a study by researchers at Vanderbilt University was published in the June 2006 edition of the New England Journal of Medicine. This study showed that there may, in fact, also be an increased risk to the fetus if it is exposed to drugs like Avapro during the first trimester. Whether the risk to the fetus is as great in the first trimester as in the second or third trimester is not known.
Some of the complications seen with fetuses or newborns exposed to Avapro during pregnancy include:
- Low blood pressure (hypotension)
- Developmental problems with the nervous system
- Developmental problems with the cardiovascular system (this includes the heart and/or blood vessels)
- Developmental problems with the lungs
- Kidney failure
- Deformities of the head and face
- Loss of life.