Brisdelle and Pregnancy
As a pregnancy Category X medication, Brisdelle (paroxetine mesylate capsules) should not be used by women who are expecting. There is no accepted medical reason for a pregnant woman to use this product, as it is only approved for use in women going through menopause. Taking this medicine while pregnant may cause serious problems, such as birth defects and withdrawal symptoms.
Brisdelle™ (paroxetine mesylate capsules) is a prescription medication approved to treat women who are experiencing hot flashes due to menopause. The medication has been given a pregnancy Category X classification, which means it should not be taken by women who are pregnant.
The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category X is given to medicines that show problems to the fetus in animal studies or in human use of the medication. With this category, the potential risks clearly outweigh the potential benefits.
Taking paroxetine (the active ingredient in Brisdelle) during the first trimester of pregnancy appears to increase the risk for birth defects overall, but especially heart problems. Some studies have shown that paroxetine use during pregnancy can as much as double the risk for heart problems in the developing fetus, especially septal defects. Septal defects occur when there is a hole in the wall of the heart.
Although the overall risk for heart problems is relatively low, Brisdelle may increase the risk from about 1 percent to about 2 percent.