Zestoretic and Pregnancy Categories C and D
Because the results of the study explained above have not been confirmed, the U.S. Food and Drug Administration (FDA) categorizes
Zestoretic as a pregnancy Category C medicine for the
first trimester and a pregnancy Category D medicine for the second and
third trimesters.
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 women but do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals automatically are given a pregnancy Category C rating.
Pregnancy Category D is given to medicines that have shown clear evidence of risk to the fetus in studies. It is a stronger warning than for pregnancy Category C medicines. Despite these warnings, a healthcare provider may still prescribe a pregnancy Category C or D medicine for a pregnant woman -- as long as the healthcare provider believes that the benefits to the woman outweigh the possible risks to the unborn child.
Recommendations for Using Zestoretic During Pregnancy
Because of the possible risks that Zestoretic poses to an unborn child even during the first trimester of pregnancy, you should be sure to let your healthcare provider know if you are pregnant or thinking of becoming pregnant. Your healthcare provider will consider both the benefits and risks of using Zestoretic during pregnancy before making a recommendation for your particular situation. In all but the rarest of situations, there are other treatment options for women who are pregnant or could become pregnant.