According to two recent studies, women who take Paxil within the first three months of pregnancy are about one and a half to two times more likely to have a baby with a heart defect as women taking other antidepressants, or no antidepressants at all.
GlaxoSmithKline, which makes Paxil, has complied with the US Food and Drug Administration’s request to change the label’s pregnancy category from C to the stronger warning of D, thereby notifying patients that studies in pregnant women have shown a risk to the fetus (FDA Public Health Advisory, 8 December 2005).