Tekturna and Pregnancy
You should not take Tekturna (aliskiren) during pregnancy. Tekturna is classified as a pregnancy Category D medication, due to the risk of birth defects and other problems. If you are taking Tekturna and pregnancy occurs, contact your healthcare provider right away.
Tekturna and Pregnancy: An OverviewTekturna® (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 D
The U.S. Food and Drug Administration (FDA) now categorizes Tekturna 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. 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 a Category D rating 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.