Paxil, (paroxetine), manufactured by GlaxoSmithKline, is a drug approved for the treatment of depression. Paxil is in a category of drugs known as selective serotonin reuptake inhibitors (SSRI’s).
Taking Paxil during pregnancy can lead to the development of heart defects and diseases in the embryo. Congenital heart disease has been linked to SSRI usage during the first trimester of pregnancy. A congenital defect is any medical condition that is present at birth.
Persistent Pulmonary Hypertension of the Newborn (PPHN) is a deadly cardiopulmonary disorder characterized by persistent elevated blood pressure in the lungs after birth causing the newborn to suffer hypoxia once outside the womb. While PPHN does exist in newborns who are not exposed to SSRIs during pregnancy, the occurrence rate for those newborns who are exposed to SSRIs during pregnancy has been shown to be over six times greater than those who are not.
On December 8, 2005, the FDA announced that it would require a label change to Paxil to include a warning indicating Paxil has been associated with an increased risk of certain types of birth defects. Two studies revealed that Paxil doubled the risk of cardiac malformations and other types of congenital defects and that women who took Paxil were twice as likely to have a baby with a heart defect as women in the general population On the same date the FDA issued an alert advising that taking Paxil during the first three months of pregnancy increases the risk for birth defects particularly heart defects.
On June 28, 2007, two additional studies were published in the New England Journal of Medicine that discussed first trimester use of SSRIs increasing the risk of certain types of congenital defects.
Williams Cuker Berezofsky is currently handling cases involving Paxil usage and congenital heart and cardiopulmonary injury. If you think you may have a case please contact us.