Paxil in the First Trimester
Women who use the antidepressant Paxil during the first trimester of pregnancy may be more likely to give birth to a child with congenital heart defects or other forms of birth defects. The Food and Drug Administration has advised doctors not to prescribe Paxil to women during the first trimester.
According to a 2005 warning issued by the FDA, women who took Paxil during the first trimester of pregnancy were twice as likely to give birth to a child with heart defects. The agency stated that the most commonly reported heart defects among this group were atrial septal defects (ASD) and ventricular septal defects (VSD), or holes in the walls of the chambers of the heart.
Based on these findings, the FDA told the manufacturer of Paxil to strengthen the drug’s warning label, moving it into the FDA’s Pregnancy Category D. Drugs that are classified as Category D have a proven risk of causing birth defects. Although this is the strongest classification short of pulling a drug from the market, the FDA has not announced any plans to issue a Paxil recall.
According to a 2007 study published in the New England Journal of Medicine, the use of Paxil during the first three months of pregnancy increases a baby’s risk of being born with heart defects. Women who used Paxil during the first trimester were three times more likely to give birth to a child with right ventricular outflow tract obstruction defects, including pulmonary valve atresia, pulmonary valve stenosis and Ebstein’s anomaly.
In addition to the increased risk of heart defects, the use of Paxil during the early stage of pregnancy could also increase the risk of other birth defects. Researchers found that women who used Paxil in the first trimester were more likely to give birth to a child with craniosynostosis, neural-tube defects, spina bifida, anencephaly, clubfoot and omphalocele.
If you or a loved one used Paxil while pregnant and gave birth to a child with heart defects or other birth defects, you may qualify to file a lawsuit. For a free legal consultation, contact the lawyers at Hissey Kientz, LLP by calling toll-free at 1-866-275-4454, or by filling out the free contact form located on this page.