Paxil Use in Early Pregnancy May Cause Birth Defects

Yael Waknine


September 28, 2005

Sept. 28, 2005 — The U.S. Food and Drug Administration (FDA) and GlaxoSmithKline have warned healthcare professionals via letter regarding the potential risk of major congenital malformations in infants born to women taking paroxetine (Paxil, Paxil CR) during the first trimester of pregnancy, according to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting system.

The warning is based on preliminary data from a retrospective company study suggesting an increase in the risk of overall congenital malformations for paroxetine compared with other antidepressants (odds ratio [OR], 2.2; 95% confidence interval [CI], 1.34 - 3.63).

The malformations paralleled those observed in the general population and were most commonly cardiovascular in nature (OR, 2.08; 95% CI, 1.03 - 4.23); 10 of 14 infants with cardiovascular malformations had ventricular septal defects.

The company notes that the causal role of paroxetine remains unclear because these and other recently published results contradict findings from previous large epidemiologic studies such as the Swedish Medical Birth Registry, which reported no increased risk for overall major malformations in 708 infants born to women with paroxetine exposure in early pregnancy.

Healthcare professionals are advised to discuss these findings with their patients and to carefully weigh the potential risks and benefits of paroxetine therapy in pregnant women. Paroxetine should only be used in pregnancy if the potential benefit justifies the potential risks to the fetus.

Additional information regarding these and other clinical trial results may be obtained by contacting the company's customer response center at 1-888-825-5249 or visiting the company clinical trial registry Web site at

Paroxetine tablets are indicated for the treatment of major depressive, obsessive-compulsive, social anxiety, generalized anxiety, posttraumatic stress, and panic disorders. Paroxetine controlled-release tablets are indicated for the treatment of major depressive, social anxiety, premenstrual dysphoric, and panic disorders.

Adverse events related to the use of paroxetine should be reported to GlaxoSmithKline at 1-888-825-5249. Alternatively, this information may be communicated to the FDA's MedWatch program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

Reviewed by Gary D. Vogin, MD


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