Labetalol and Pregnancy

In some animal studies involving labetalol and pregnancy, the drug appeared to have an adverse effect on fetuses. Although labetalol has not been studied in pregnant women, it is thought that it may increase the risk for health problems in the unborn child. The Food and Drug Administration (FDA) considers labetalol to be a pregnancy Category C medicine; however, a healthcare provider still may prescribe labetalol to a woman who is pregnant if he or she believes that the benefits outweigh the risks.

 

Is Labetalol Safe for Women Who Are Pregnant?

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

Labetalol 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 is given 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). The FDA also automatically gives a pregnancy Category C rating to medicines that have not been studied in any pregnant women or animals.
 
A healthcare provider can still prescribe a pregnancy Category C medicine to a pregnant woman if he or she believes that the benefits to the pregnant 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.
 
(Labetalol 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;