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 adequately in pregnant women, it may increase the risk for health problems in the unborn child. The FDA considers labetalol a pregnancy Category C medicine; however, a healthcare provider still may prescribe it if he or she believes that the benefits outweigh the risks.
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 might not be safe for use during pregnancy, although the full risks are currently unknown.
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.
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 adequately 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.