Paxil® Use during Pregnancy

Following a study that found a slightly increased risk of birth defects in children whose mothers used Paxil® during the first three months of pregnancy, the makers of the drug added a warning to the antidepressant's label. GlaxoSmithKline, the manufacturer of Paxil®, also sent advisory letters to physicians in September of 2005, alerting them about the possible risk of birth defects associated with Paxil® use.

Increased Risk of Birth Defects

In a study requested by the FDA and conducted by GlaxoSmithKline, evidence of a heightened risk of birth defects was found. The study included 3,581 pregnant women who were using antidepressants and it found that 4 percent of babies exposed to Paxil® during the first trimester of pregnancy were born with birth defects. This is slightly higher than the rate of birth defects found in the general population (3 percent).

According to the findings of another study, the rate of heart defects in babies exposed to Paxil® during the first three months of pregnancy is about 2 percent. The rate of heart malformations in the general population is about 1 percent. Most of the cardiac defects linked to Paxil® use involve holes in the atrial and ventricular chambers of the heart. While some of the heart defects have repaired themselves on their own, some required surgical operation and medical care.

In response to these studies, the FDA requested that GlaxoSmithKline strengthen Paxil®'s warning labels, advising consumers about the potential dangers Paxil® use can pose during pregnancy.

What to Do if Your Baby Was Harmed as a Result of Paxil® Use

If you used Paxil® during pregnancy and your baby suffered birth defects, it is important to contact an attorney well versed in defective drug litigation as soon as possible. You may be entitled to compensation for medical bills, emotional distress, and lost wages. Contact a Paxil® lawyer for a case evaluation.

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