SSRI Use in Pregnancy Linked to Risk for Pulmonary Hypertension in Newborns

Yael Waknine

Disclosures

July 20, 2006

July 20, 2006 — The US Food and Drug Administration (FDA) has warned healthcare professionals of new findings regarding the potential risks associated with both discontinuation and continuation of antidepressant therapy during pregnancy.

The warning was based on 2 studies performed in women receiving selective serotonin reuptake inhibitors (SSRIs) or other drugs (in a few cases), according to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program.

Data from the first study revealed that women who discontinued antidepressant therapy were 5 times more likely to have a relapse during pregnancy compared with those who continued treatment.

Results of the second study suggested that there may be a rare risk associated with SSRIs during pregnancy; continued use of antidepressants past the 20th week of pregnancy was linked to a 6-fold increase in the risk for persistent pulmonary hypertension (PPHN) in newborns.

PPHN, which typically occurs in 1 or 2 per 1000 births, often involves severe respiratory failure that requires immediate treatment.

Although the study was too small to compare individual drugs and the risk has thus far not been investigated by other studies, the FDA notes that the potential risk adds to growing concerns regarding use of SSRIs during pregnancy.

Newborn adverse events previously reported in association with continued use include irritability, difficulty feeding, and rare cases of difficulty breathing. In addition, use of paroxetine HCl (Paxil, made by GlaxoSmithKline) during the first trimester has been epidemiologically linked to an increased risk for cardiac birth defects.

The FDA advises that women receiving antidepressant therapy who are pregnant or thinking about becoming pregnant consult with their healthcare professional prior to discontinuing or continuing antidepressant therapy; such a decision should only be made after careful individualized consideration of the risks and benefits associated with treatment. Patients who elect to discontinue therapy should be closely monitored for depression relapse.

Additional studies are being conducted regarding the potential risk for PPHN associated with use of SSRIs during pregnancy. As findings become available, corresponding safety labeling revisions will be made for citalopram HBr (Celexa, made by Forest Laboratories, Inc); fluvoxamine (previously marketed as Luvox by Solvay Pharmaceuticals, Inc, and now available in generic formulations); escitalopram oxalate (Lexapro, made by Forest Laboratories, Inc); paroxetine HCl (Paxil, made by GlaxoSmithKline), fluoxetine HCl (Prozac, made by Eli Lilly and Company); olanzapine/fluoxetine (Symbyax, made by Eli Lilly); and sertraline HCl (Zoloft, made by Pfizer, Inc).

Healthcare professionals are encouraged to report SSRI-related adverse events to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

Reviewed by Gary D. Vogin, MD

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