The FDA has issued a MedWatch Alert based on the results of studies that show a significant link between taking Paxil (paroxetine) during the first trimester of pregnancy and birth defects.
Preliminary analyses from two recent unpublished epidemiological studies have shown that paroxetine use in the first trimester of pregnancy is associated with an increased risk of specific types of congenital malformations. In a study based on Swedish national registry data, infants exposed to paroxetine in early pregnancy had an approximately two-fold increased risk for cardiac defects compared to the entire national registry population, about 2% in paroxetine-exposed infants vs. 1% in the total population. The majority of cardiac defects in paroxetine-exposed infants were atrial and ventricular septal defects.
In a separate study using a United States (U.S.) insurance claims database, infants of women who received paroxetine in the first trimester had a 1.5-fold increased risk of cardiovascular malformations compared to infants of women who received other antidepressants in the first trimester, 1.5% in the paroxetine-exposed infants vs. 1% in infants exposed to other antidepressants. The majority of the cardiovascular defects observed in this study were ventricular septal defects.
Exposure to paroxetine in the first trimester was also associated with an approximately two-fold higher risk for overall congenital malformations (including cardiovascular malformations) compared to exposure to other antidepressants in the first trimester, about 4% vs. 2% prevalence of all congenital malformations. Separate analyses were not done for any specific malformations other than cardiovascular malformations.
The new information sheet supplied with the drug says the following.
Early results of new studies show that paroxetine increases the risk of birth defects, particularly heart defects, when women take it during the first three months of pregnancy. Paroxetine should usually not be taken during pregnancy, but for some women who have already been taking paroxetine, the benefits of continuing paroxetine may be greater than the potential risk to the baby. Women taking paroxetine who are pregnant, think they may be pregnant, or plan to become pregnant should talk to their physicians about the potential risks of taking paroxetine during pregnancy.
The early results of two studies showed that women who took paroxetine (Paxil) during the first three months of pregnancy were about one and a half to two times as likely to have a baby with a heart defect as women who received other antidepressants, and women in the general population. Most of the heart defects in these studies were not life-threatening, and happened mainly in the inside walls of the heart muscle where repairs can be done if needed (atrial and ventricular septal defects). Sometimes these septal defects resolve without treatment. In one of the studies, the risk of heart defects in babies whose mothers had taken paroxetine early in pregnancy was 2%, compared to a 1% risk in the whole population. In the other 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 who took paroxetine in the first three months of pregnancy were about twice as likely to have a baby with any birth defect as women who took other antidepressants.
Note that important statement above: Paroxetine should usually not be taken during pregnancy. No one suffering with depression and trying to cope with the multiple side-effects of pharmaceutical drugs should risk exposure to the impact of this adverse effect which would only serve to significantly worsen their condition. If you know someone for whom this new information from the FDA is relevant, please pass it on and ask them to consult their prescriber. Better yet, also recommend a naturopathic doctor.
