Paxil And Babies

Long-time readers of this blog know that GlaxoSmithKline lost the trial in which we were privileged to serve as co-trial counsel, its first loss for the death of an adult over its drug.  Now that it has lost its trial in the case of a baby damaged by Paxil (paroxetine), GSK would like us to doubt that verdict should stand.  However, scientific and medical studies support the jury’s decision.  These studies have shown that Paxil puts infants at increased risk for cardiac malformations and pulmonary hypertension.

A Swedish study showed that infants in the womb who were exposed to paroxetine during pregnancy had a 2% increased risk of heart malformations.  These defects can occur in two ways.  The first is ventricular septal defects (VSD).  The second category is atrial septal defects (ASD).  Some of these were so severe that they required surgical repair.

A United States study included 5,956 infants of mothers who had taken antidepressants during the first three months of pregnancy.  It found a 50% increase in the risk for heart malformations in infants whose mothers took Paxil compared to other antidepressants.  This study, like the Swedish study, showed the injuries included cardiovascular defects  and other major congenital malformations.

In any study, there should be a reasonably large group of people.  Two more case-control studies used separate databases.  Each one studied more than 9,000 birth defect cases and more than 4,000 controls.  These two additional studies found that fetal exposure to Paxil during the first trimester caused a two to three times increase in right ventricular outflow tract obstructions.

This entry was posted on Monday, December 7th, 2009 at 12:33 am and is filed under Paxil News. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.