Lotensin HCT and Pregnancy

There are some situations where taking Lotensin HCT is not recommended, and pregnancy is one of them. The FDA has determined that taking Lotensin HCT during any trimester of pregnancy poses health risks to the fetus. Some complications seen with fetuses or newborns exposed to Lotensin HCT during pregnancy include developmental problems with the cardiovascular or nervous systems, deformities of the head or face, and loss of life.

 

Is Lotensin HCT Safe During Pregnancy?

For people who are pregnant, Lotensin HCT® (benazepril hydrochloride and hydrochlorothiazide) is not recommended. This is because during pregnancy, Lotensin HCT can lead to temporary or permanent problems, including death, in the unborn child.
 

Lotensin HCT and Pregnancy Category D

The U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Lotensin HCT is considered a pregnancy Category D medicine by the FDA. Pregnancy Category D is given to medicines that have shown clear evidence of risk to the fetus in studies. A pregnancy Category 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 Lotensin HCT During Pregnancy?

Prior to 2006, there was a common belief among healthcare providers that problems with Lotensin HCT 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, be an increased risk to the fetus if it is exposed to Lotensin HCT during the first trimester.
 
Some of the complications seen with fetuses or newborns exposed to Lotensin 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
  • Jaundice (yellowing of the skin and whites of the eyes)
  • Deformities of the head and face
  • Death.
     
(Lotensin 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;