Diovan HCT and Pregnancy

Pregnant women are usually recommended not to take Diovan HCT. During any trimester of pregnancy, Diovan HCT can cause temporary or permanent problems to an unborn child. Among the complications seen with fetuses or newborns exposed to Diovan HCT during pregnancy are deformities of the head and face, developmental problems with the nervous or cardiovascular systems, and even loss of life. If you're taking Diovan HCT and pregnancy occurs (or if you are thinking of becoming pregnant), let your healthcare provider know.

 

Is Diovan HCT Safe During Pregnancy? -- An Overview

Taking Diovan HCT® (valsartan and hydrochlorothiazide) during pregnancy is usually not recommended. This is because during pregnancy, Diovan HCT can cause temporary or permanent problems, including death, to the unborn child.
 

Diovan HCT and Pregnancy Categories C and D

The U.S. Food and Drug Administration (FDA) categorizes Diovan 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 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 show side effects to the fetus in animal studies, but for which 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 the studies. Pregnancy Category D is a stronger warning than a pregnancy Category C classification. 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.
 

What Is the Risk of Using Diovan HCT During Pregnancy?

Some of the complications sometimes seen in fetuses or newborns exposed to Diovan 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.
     
(Diovan 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;