Avalide and Pregnancy

The blood pressure drug Avalide (irbesartan/HCTZ) is classified as a pregnancy Category D medication. This means that taking it during pregnancy may be harmful to the unborn child. Some of the problems Avalide may cause in the newborn include low blood pressure, skull deformity, and kidney problems.

Can Pregnant Women Take Avalide?

Avalide® (irbesartan/HCTZ) is a prescription medication used in the treatment of hypertension (high blood pressure). It combines two drugs, irbesartan and hydrochlorothiazide (or HCTZ for short), into one pill. Taking Avalide during pregnancy may be harmful to the unborn child.
 

What Is Pregnancy Category D?

The U.
 S. Food and Drug Administration (FDA) categorizes Avalide as a pregnancy Category D medicine for all trimesters (previously, it was a Category C medicine for the first trimester and a 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 have not been adequately studied in pregnant humans but did appear to cause harm to the fetus in animal studies.
 
In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
 
Pregnancy Category D is a classification given to medicines that have been shown to present a risk to the fetus in studies of pregnant women, but may still offer benefits that outweigh the risks the drug presents. A pregnancy Category D medicine may still be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh the possible risks to her unborn child.
 
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Written by/reviewed by: Susan Lakey, PharmD, MPH
Last reviewed by: Kristi Monson, PharmD
 
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