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.
Contact Us:
Davis & Feder P.A. is now handling claims for babies born with an antidepressant
birth defect. Davis & Feder P.A. 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 1-866-857-8500
