In September of 2005, the Food and Drug Administration (FDA) issued a warning regarding possible birth defects associated with the use of Paxil if taken during the first trimester of pregnancy. This warning was based on two studies. The first study found a 2% risk of heart defects in babies born to mothers who took Paxil early in their pregnancy compared to a 1% risk in the general population. The second study found a 1.5% risk of heart defects in babies whose mothers took Paxil in the first three months of pregnancy compared with 1% in babies whose mothers took other antidepressants in the first three months.


Most of the cardiac birth defects found in the study were either atrial or ventricular septal defects. One of the more serious conditions associated with the use of anti-depressants in the first trimester is a condition known as persistent pulmonary hypertension of the newborn (PPHN). This is a condition that affects blood flow to the lungs and can even cause death.


In December of 2005, the FDA instructed GlaxoSmithKline, the manufacturer of Paxil, to reclassify the drug from a Class C drug to a Class D drug. A Class D drug carries a stronger warning. Other reports have indicated that SSRIs, the category of anti-depressants that includes Paxil, Zoloft, Prozac and Lexapro may cause newborns to have withdrawal symptoms. Other antidepressants classified as SSRIs include Luvox and Celexa.


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Davis & Crump is now handling claims for babies born with an antidepressant birth defect. Davis & Crump is experienced in pharmaceutical product liability cases and settlements. If you took antidepressants while pregnant and your baby was born with a birth defect, contact us at 1-800-277-0300 or send us an email at info@daviscrump.com.