Diovan 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
Diovan 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 show side effects to the fetus in animal studies, but for which no human studies in pregnant women have been done. Pregnancy Category D is given to medicines that have shown clear evidence of risk to the fetus in studies. Pregnancy Category D is a stronger warning than a pregnancy Category C classification. Despite these warnings, a pregnancy Category C or D medicine may still be given to a pregnant woman if her healthcare provider believes that its benefits outweigh the possible risks to the unborn child.
Diovan and Pregnancy: Recommendations
Because of the possible risks that Diovan poses to an unborn child, even during the first trimester of pregnancy, 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 Diovan during pregnancy before making a recommendation for your particular situation. In all but the rarest of situations, there are other options for women who are pregnant or could become pregnant.
Previous