Vivelle-Dot and Pregnancy
If you are using Vivelle-Dot and pregnancy occurs, you should contact your healthcare provider immediately. Although unintentionally using the medication during pregnancy is not likely to cause serious problems, you must still discuss the potential risks with your healthcare provider. There is no legitimate medical reason for a pregnant woman to use Vivelle-Dot.
Pregnant women should never use Vivelle-Dot® (estradiol patch). It is important to understand that estrogens (such as Vivelle-Dot) are not effective for preventing miscarriages or other problems in pregnancy and that there is no accepted medical reason for pregnant women to use Vivelle-Dot.
The U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category X is given to medications that should not be used during pregnancy, usually due to serious problems that could occur (such as birth defects or miscarriages).
Although Vivelle-Dot is a Category X medication, it does not appear to increase the risk of birth defects or other problems. However, because there is no accepted, legitimate medical reason for pregnant women to use Vivelle-Dot, and because the risks are not fully understood, it should not be used during pregnancy.
Vivelle-Dot is not approved for any use in pregnant women. If you unintentionally used Vivelle-Dot for a while before you realized you were pregnant, it will probably not cause any problems (although you should discuss this with your healthcare provider). If you think you may be pregnant, you should contact your healthcare provider for further instructions.