Paxil During Pregnancy

The Food and Drug Administration has warned that children born to women who took the antidepressant drug Paxil while pregnant are at an increased risk of congenital heart defects and other birth defects. The agency stated that these dangers may be present regardless of whether Paxil is taken during the early or later stages of pregnancy.

The FDA’s first warning about the link between Paxil and birth defects was issued in December 2005. According to two studies, women who took Paxil during the first trimester of pregnancy were twice as likely to give birth to children with birth defects. The most commonly reported birth defects in the study were atrial septal defects (ASD) and ventral septal defects (ASD), hole in the walls that separate the chambers of the heart.

In July 2006, the FDA issued a second warning involving women who took Paxil during pregnancy. A study of women who were treated with antidepressants such as Paxil after the 20th week of pregnancy found that their children were six times more likely to develop persistent pulmonary hypertension of the newborn (PPHN), a serious and potentially fatal circulatory condition.

Based on the information that led to its warning about Paxil, the FDA has upgraded the antidepressant from a Category C to a Category D drug, meaning that it can cause danger to the fetus. Despite this stronger classification, however, neither the FDA nor GlaxoSmithKline (GSK), the drug’s manufacturer, have announced plans to issue a Paxil recall.

Hundreds of families have filed lawsuits against GSK on behalf of children who were born with congenital birth defects or other side effects of Paxil. Lawyers estimate that GSK has paid over $1 billion in settlements as of July 2010.

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