Tekturna and Pregnancy

You should not take Tekturna (aliskiren) during pregnancy. Tekturna is classified as a pregnancy Category C medication during the first trimester (as it can cause birth defects) and as a pregnancy Category D medication during the second and third trimesters (as it can cause fetal death, skull problems, and severe kidney problems). If you are taking Tekturna and pregnancy occurs, contact your healthcare provider right away.

 

Tekturna and Pregnancy: An Overview

Tekturna® (aliskiren hemifumarate) is a prescription medication approved to treat high blood pressure (hypertension). Pregnant women should not take Tekturna, due to potential problems that were seen with medications similar to it.
 

Tekturna and Pregnancy Category C or D

Tekturna is classified as a pregnancy Category C medication in the
 first trimester and as a Category D medication when used in the second or third trimester. The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Category C and D are defined as follows:
 
  • Pregnancy Category C -- Medications that have not been studied in pregnant humans but that have been shown to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
     
  • Pregnancy Category D -- Medications that have been shown to present a risk to the fetus in studies of pregnant women but that 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 the unborn child.
     
Tekturna was given these classifications based on problems seen with other related blood pressure medications. Because of the problems these medications caused during pregnancy, Tekturna has not been studied in any pregnant women.
 
(Tekturna 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;