Benicar HCT and Pregnancy: An Overview
For people who are pregnant, Benicar HCT®
(olmesartan medoxomil hydrochlorothiazide
) is usually not recommended. This is because during pregnancy, the drug can cause temporary or permanent problems for the unborn child, including death.
Benicar HCT and Pregnancy Categories C and D
The U.S. Food and Drug Administration (FDA) categorizes Benicar
HCT as a pregnancy Category C medicine for the first trimester
and a pregnancy Category D medicine for the second and third trimesters
The FDA uses a 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 show side effects to the fetus in animal studies but no human studies in pregnant women have been done. Pregnancy Category D is given to medicines that have shown clear evidence of risk to the fetus in human studies. Pregnancy Category D is a stronger warning than a pregnancy Category C medicine. Despite these warnings, a pregnancy Category C or D medicine may still be given to a pregnant woman if her healthcare provider believes that its benefits outweigh the possible risks to the unborn child.
Benicar HCT and Pregnancy: What Is the Risk?
Some of the complications seen with fetuses or newborns exposed to Benicar HCT 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
- Jaundice (yellowing of the skin or the whites of the eyes)
- Loss of life.