Paroxetine causes birth defects

Article

The FDA recently issued an alert based on early findings of two new studies suggesting that paroxetine (Paxil, GlaxoSmithKline [GSK]) increases the risk for congenital malformations, particularly those of a cardiac nature, when it is taken by women during the first trimester of pregnancy.

The FDA recently issued an alert based on early findings of two new studies suggesting that paroxetine (Paxil, GlaxoSmithKline [GSK]) increases the risk for congenital malformations, particularly those of a cardiac nature, when it is taken by women during the first trimester of pregnancy.

The as-yet-unpublished epidemiology studies indicate that women who take the drug during the first 3 months of pregnancy are one and a half to two times as likely to have a baby with a heart defect as women who take other antidepressants or none at all. Most of the defects consisted of atrial and ventricular septal defects, ranging in severity from minor to requiring surgical repair.

As a result of the studies, the FDA has asked and GSK has agreed to change the pregnancy category of paroxetine from C to D, which indicates that controlled or observational studies in pregnant women have demonstrated a risk to the fetus. The manufacturer has also added information to the Warnings section of paroxetine's labeling.

Recent Videos
Elizabeth Gandee, APRN-CNP, highlights gaps in women's menopause knowledge | Image Credit: wexnermedical.osu.edu
Doula highlights how postpartum care is failing new mothers | Image Credit: linkedin.com
Nicky Herrick MD; and Anushree Agarwal, MD, MBBS, highlight their study on cardiac arrhythmias in pregnancy | Image Credit: © Igor Borodin - stock.adobe.com.
Lisa Becht, MD, FACOG, sheds light on fertility awareness | Image Credit: havingbabies.com.
First US national HPV conference highlights advances in cancer prevention | Image Credit: uchealth.com.
Mitchell Creinin, MD, reports estetrol pill eases menstrual symptoms | Image Credit: health.ucdavis.edu
1 expert is featured in this series.
Susanna Mitro, PhD, reveals ethnic disparities in uterine fibroid diagnosis | Image Credit: divisionofresearch.kaiserpermanente.org.
Shayna Mancuso, DO, highlights the real impact of menopause | Image Credit: linkedin.com.
Jihong Liu, ScD, explains how to improve perinatal outcomes in COVID patients | Image Credit: sc.edu.
Related Content
© 2025 MJH Life Sciences

All rights reserved.