Did you take PAXIL during your pregnancy?

Paxil, a drug in the class of anti-depressants known as selective serotonin reuptake inhibitors (SSRIs), has been linked to birth defects -- in particular, heart defects. SSRIs are prescribed for the treatment of depression and anxiety disorders. Manufactured by Glaxo-Smith Kline, Paxil (paroxetine) was released in 1992 and has become one of the most widely sold antidepressants ever.

In one of the studies, the risk of heart defects in babies whose mothers had taken Paxil early in pregnancy was about 2 percent, compared to a 1 percent risk in the whole population. In the other study, the risk of heart defects in babies whose mothers had taken Paxil in the first three months of pregnancy was 1.5 percent, compared to 1 percent in babies whose mothers had taken other antidepressants in the first three months of pregnancy. FDA has asked the manufacturer, Glaxo Smith Kline (GSK), to change the pregnancy category from C to D, a stronger warning. Category D means that studies in pregnant women (controlled or observational) have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risks to the fetus. Based on results of the preliminary data, GSK updated the drug's labeling in September 2005 to add data from one study. As additional data have become available, the label has now been changed to reflect the latest data from the two studies and to change the pregnancy category.

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