FDA ALERT : Zoloft Drug Alert – Persistent Pulmonary Hypertension of the Newborn (PPHN) Side Effects Risk

The drug alert set out below was issued by the U.S. Food and Drug Administration (FDA) in July 2006. It was last updated on July 23, 2010. This FDA alert is intended to provide post market (after FDA approval) safety information about Zoloft (setraline) to patients, doctors and healthcare professionals. The Zoloft drug safety issues described in this FDA alert have been addressed in the labeling of Zoloft (setraline).

PPHN stands for Persistent Pulmonary Hypertension of the Newborn, a life-threatening condition that develops soon after and infant is born. Pulmonary means related to the lung. Hypertension means high blood pressure. The pressure in the blood vessels to the lungs of a baby with PPHN is so high that bloodflow into the lungs is restricted and the amount of oxygen that gets into the bloodstream is limited. As a result, other organs in the body do not get enough oxygen to function properly. A baby with PPHN has breathing problems soon after birth. A baby with PPHN suffers high blood pressure to the lungs that prevents enough oxygen from getting into the bloodstream. PPHN may result in heart failure, brain hemorrhage, seizures, kidney failure and multiple organ damage. The most severe cases of PPHN often result in death.

You may be entitled to financial compensation. If you or a loved one took Zoloft (setraline) during pregnancy and your baby suffered Persistent Pulmonary Hypertenstion of the Newborn (PPHN), you may have a right to recover financial compensation. Get a free no-obligation consultation with a Zoloft PPHN lawsuit attorney. Submit the attorney contact form on this page or call us at toll-free. 800-845-6913

FDA ALERT [7/2006]: Increased Risk of Neonatal Persistent Pulmonary Hypertension

A recently published case-control study has shown that infants born to mothers who took selective serotonin reuptake inhibitors (SSRIs) after the 20th week of pregnancy were 6 times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy (see SSRI drug names at the bottom of this sheet). The background risk of a woman giving birth to an infant affected by PPHN in the general population is estimated to be about 1 to 2 infants per 1000 live births. Neonatal PPHN is associated with significant morbidity and mortality. The FDA is updating the prescribing information for all SSRIs with this new information. The FDA is also accruing data from additional sources pertaining to the potential association between SSRIs and neonatal PPHN. The FDA will provide additional information when it becomes available. In the interim, the FDA recommends that physicians carefully consider and discuss with patients the potential risks and benefits of SSRI treatment throughout pregnancy, including late pregnancy.

This information reflects FDA’s current analysis of data available to FDA concerning these drugs. FDA intends to update this sheet when additional information or analyses become available.


To report any unexpected adverse or serious events associated with the use of this drug, please contact the FDA MedWatch program using the contact information at the bottom of this page. 

Considerations

Physicians should consider the benefits and risks of treating pregnant women with SSRIs, alternative treatments, or no treatment late in pregnancy.

Data Summary

A retrospective case-control study published on February 9, 2006, in the New England Journal of Medicine assessed the risk for persistent pulmonary hypertension of the newborn (PPHN) following exposure to SSRIs during pregnancy. 377 women whose infants were born with PPHN and 836 women whose infants were healthy were enrolled in the study in four United States metropolitan areas between 1998 and 2003. The study showed that infants born to mothers who took SSRIs after the completion of the 20th week of gestation were 6 times more likely to have PPHN than infants who were not exposed to antidepressants during pregnancy. 14 infants with PPHN and 6 healthy control infants had been exposed to an SSRI after the 20th week of gestation. There were too few cases of PPHN with each individual SSRI to compare risks for PPHN with individual SSRIs. The study did not find an association between exposure to SSRIs during the first 20 weeks of gestation and PPHN.

Exposure to non-SSRI antidepressants did not appear to be associated with an increased risk of PPHN, although the number of infants with exposure to non-SSRI antidepressants was too small to permit a reliable risk estimate or comparison with the risk observed for SSRIs.

In weighing the risks and benefits of treatment with SSRIs and other antidepressants during pregnancy for individual patients, physicians should also note the recent publication of a prospective longitudinal study of 201 pregnant women with a history of major depression in the February 1, 2006, issue of JAMA. In this study, women who discontinued antidepressant medication during pregnancy had a higher risk of relapse of major depression during pregnancy (68%) than women who maintained antidepressant medication throughout pregnancy (26%).

SSRI Drug Names

  • Celexa (citalopram)
  • Fluvoxamine
  • Lexapro (escitalopram)
  • Paxil (paroxetine)
  • Prozac (fluoxetine)
  • Symbyax (olanzepine/fluoxetine)
  • Zoloft (sertraline)

Zoloft Septal Heart Defect Lawsuit Attorneys

The use of selective serotonin reuptake inhibitor (SSRI) antidepressants such as Zoloft during pregnancy has been found to increase the risk of an infant suffering Persistent Pulmonary Hypertension of the Newborn (PPHN).

Zoloft lawsuit attorneys represent families and children affected by Zoloft PPHN on their claims recover financial compensation for personal injury and wrongful death damages.

If you or a loved one may have a Zoloft PPHN lawsuit case or a claim to a Zoloft PPHN settlement, contact us today for a free no-obligation consultation with a Zoloft birth defects lawyer. Submit the attorney contact request form on this page or call us toll-free. 800-845-6913