Pregnant women
The first results of new studies show that paroxetine increases the risk of birth defects, especially heart defects, when women take it during the first three months of pregnancy. Paroxetine should not normally be taken during pregnancy, but for some women who have already taken paroxetine, the benefits of continuing paroxetine may be greater than the potential risk to the baby. Women taking paroxetine pregnant, I believe that she may be pregnant or plan to become pregnant should talk with their doctors about the potential risks of taking paroxetine during pregnancy.
The first results from two studies showed that women who took the paroxetine (Paxil) during the first three months of pregnancy were one and average twice the likely having a baby with a heart defect as women who received other antidepressants and women in the general population. Most of the defects of the heart in these studies were not fatal and occurred mainly within the walls of the heart muscle where repairs can be made if it is necessary (defects, atrial and Ventricular septal). Sometimes these septal defects resolve without treatment. In one study, the risk of heart defects in babies whose mothers had taken early paroxetine in pregnancy was 2%, compared to a risk of 1% in the population as a whole. In another study, the risk of heart defects in babies whose mothers had taken paroxetine in the first three months of pregnancy was 1.5%, compared to 1% in babies whose mothers had taken other antidepressants in the first three months of pregnancy. This study also showed that women taking paroxetine in the first three months of pregnancy were approximately twice as likely to have a baby with a birth defect as women who took other antidepressants.
The FDA is in the process of collecting additional data to better understand these comments.
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