Blood Pressure Home > Tribenzor and Pregnancy
The U.S. Food and Drug Administration classifies Tribenzor (olmesartan medoxomil/amlodipine/hydrochlorothiazide) as a pregnancy Category C medication during the first trimester and a Category D drug during the second and third trimesters. This means that it may not be safe for pregnant women to use this medication. Some animal studies indicated that the drug might cause several problems, such as birth defects and even death.
Can I Take Tribenzor When Pregnant?Tribenzor™ (olmesartan medoxomil/amlodipine/hydrochlorothiazide) is a prescription medication used to treat high blood pressure, known medically as hypertension. It contains three medications -- olmesartan (Benicar®), amlodipine (Norvasc®), and hydrochlorothiazide.
Tribenzor may cause harm to an unborn child, based on the results of animal studies and problems reported when pregnant women took hydrochlorothiazide and medications like olmesartan, two of the components of Tribenzor.
What Are Pregnancy Categories C and D?Tribenzor is classified as a pregnancy Category C drug when used in the first trimester. However, when used during the second or third trimesters, Tribenzor is a Category D drug.
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. Pregnancy Category C is given to medicines that have not been studied in pregnant humans, but appear 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 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 the unborn child.