Trandate and Pregnancy

Trandate and pregnancy have not been studied together in humans, but in some studies of pregnant animals, the medicine appeared to have an adverse effect on fetuses. Therefore, the Food and Drug Administration (FDA) has classified Trandate as a pregnancy Category C medicine, which means that there may be an increased risk to the fetus if Trandate is used during pregnancy. A doctor may prescribe Trandate for a pregnant woman if he or she believes that its benefits outweigh the possible risks to the unborn child.

 

Is Trandate Safe In Pregnancy? -- An Overview

Whether or not your healthcare provider recommends taking Trandate® (labetalol hydrochloride) while you are pregnant will depend on your particular situation. Trandate is considered a pregnancy Category C medicine by the U.S. Food and Drug Administration (FDA), which means that Trandate has not been studied in pregnant women. However, when Trandate was studied in pregnant animals, it appeared to have an adverse effect on fetuses. This means that there may be an increased risk to the fetus if Trandate is used during pregnancy. In your situation, your healthcare provider will consider the risk of Trandate, the risk of not treating your condition, and alternative treatment options before making his or her recommendation.
 

Trandate and Pregnancy Category C

The 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 refers to medicines that have not been studied in pregnant humans but show side effects to the fetus during animal studies. These side effects can either be temporary (such as a slowed heart rate at birth) or, in some cases, permanent (birth defects). Also, medicines that have not been studied in any pregnant women or animals automatically are given a pregnancy Category C rating.
 
A healthcare provider may still prescribe a pregnancy Category C medicine for a pregnant woman if he or she believes that the benefits to the woman outweigh the possible risks to the unborn child. For example, untreated high blood pressure during pregnancy carries its own set of significant risks to both the mother and the fetus (see Preeclampsia). In situations like this, a healthcare provider may prescribe a pregnancy Category C medicine if the benefit of treating high blood pressure in pregnancy outweighs the risk of the medicine.
 
(Trandate 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;