Benicar HCT and Pregnancy

Studies on Benicar HCT and pregnancy have led the drug to be classified a pregnancy Category C medicine for the first trimester and a pregnancy Category D medicine for the second and third trimesters. The drug is usually not recommended for pregnant women because it can cause developmental problems in a fetus or even death. If you are taking Benicar HCT and pregnancy occurs, your healthcare provider may prescribe a different medication.

 

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.
     
(Benicar HCT and Pregnancy Continued: Page 2)
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;