Is the Antidepressant Zoloft Safe During Pregnancy?

Reviewed by Terri Forehand RN
Woman consulting her OB about antidepressants

Women who are pregnant or considering pregnancy are anxious to ensure that their baby is not exposed to unhealthy foods or unsafe medications. According to an article published in the American Journal of Obstetrics & Gynecology (AJOG), increasing numbers of women take Zoloft (Sertraline HCL) or other antidepressants during pregnancy, as part of their treatment regimen for depression or other mood disorders. Therefore, the safety of these drugs in pregnancy is an important consideration for many women.

Make an Informed Decision

If you are being treated for a mood disorder, it is a good idea for you to discuss your Zoloft prescription with your partner and doctor before you get pregnant. Review all your other medications as well. This will allow you to make treatment decisions without the added stresses and emotions of pregnancy.

As with any other medication you may be taking, the decision to continue Zoloft during your pregnancy is a difficult one to make. Every drug carries some degree of risk to the developing fetus. The magnitude of the risk and safety of Zoloft and its family of antidepressant drugs during pregnancy is uncertain and requires further study. You and your doctor must carefully weigh the risks of exposing your fetus to Zoloft against the risks to you of discontinuing the drug.

Risks to the Fetus of Exposure to Zoloft

Zoloft belongs to a group of antidepressant drugs called Selective Serotonin Reuptake Inhibitors (SSRIs). Sertraline HCL was first used in the UK under the brand name, Lustral in 1990 before it was approved for use in the U.S. in 1991 as brand name Zoloft. It is most commonly used to treat depression but it is also used to treat other mood disorders.

The current knowledge of the risks of SSRIs to the developing fetus is unclear because the available studies give conflicting results and conclusions. There is also no information on the dose of the SSRI and risks to the fetus. Because of these uncertainties, be cautious.

Possible Increased PPHN Risk

The risk of greatest concern from a few studies is that of Persistent Pulmonary Hypertension (PPHN) in the newborn. This disease is rare in unexposed newborns, but the risk might increase if your baby is exposed to SSRIs during your pregnancy. There are no definitive, well-designed studies that prove the risk of PPHN or other ill effects in babies exposed to SSRIs. However, because PPHN in an infant can be catastrophic and lead to death, caution is needed if you are taking Zoloft or another SSRI.

What Happens with PPHN

Babies with PPHN have high pressures in the blood vessels in their lungs. This restricts the flow of blood from the baby's heart through the lungs. Therefore the baby's blood cannot adequately replenish oxygen. This leads to poor oxygen circulation and the baby can get sick very quickly after birth. PPHN can lead to failure of many organs and death.

U.S. FDA Recommendation

In 2006, the U.S. Food and Drug Administration (FDA) issued an initial drug alert on the use of SSRIs in pregnancy due to a possible link between their usage and PPHN. This alert was based on a 2006 study published in the New England Journal of Medicine (NEJM). The study showed:

  • Increased risk of PPHN in newborn babies whose mothers took Zoloft or other SSRIs during pregnancy
  • Babies exposed to SSRIs appeared to be six times more at risk for PPHN than unexposed babies
  • This increased risk of PPHN appears to occur in babies exposed during the second half of pregnancy (after the 20th week)

Based on this limited study, the FDA concluded there was not enough evidence to recommend discontinuing SSRIs during pregnancy. They advised discussion between doctors and their patients, as well as the need for further study.

In 2011 the FDA issued a follow-up alert based on the results of conflicting new studies. They concluded that the association between SSRIs and PPHN was still unclear and that doctors could continue to treat depression during pregnancy and report adverse events. Some of the follow-up studies showed an increased risk of PPHN and others do not.

A further study published in the British Medical Journal (BMJ) in 2014 showed more evidence that babies exposed to SSRIs in the second half of pregnancy had an increased risk for PPHN. As of June of 2014, the FDA has not changed its recommendations in response to this study.

Other Abnormalities Reported in Newborns

Other abnormalities reported in babies exposed to Zoloft or other SSRIs in pregnancy include low birth weight, premature delivery, other heart defects, cleft lip and palate, and anencephaly (brain fails to develop). As with PPHN, the degree of association and risk is unclear.

Newborns exposed to SSRIs during pregnancy may also display symptoms of drug withdrawal, such as irritability, after delivery. The data on the effect of maternal depression itself on neonatal outcome is also unclear.

Risks to the Mother of Stopping Zoloft

Pregnancy is a time of fluctuating emotions so symptoms of depression or other mood disorders may worsen. If you are taking Zoloft for depression and stop taking it because you are pregnant, or are considering pregnancy, your symptoms may return in full force.

A 2006 study published in the Journal of the American Medical Association (JAMA), concluded that women who stopped their antidepressants during pregnancy were at greater risk for return of their depression symptoms than those who stayed on their medication. You might also find that your symptoms of depression worsen in the postpartum period and increase your risks of neglecting or harming your newborn during this time.

It is important not to stop Zoloft abruptly on your own because you may have side effects or experience worsening of your depression or other mood disorder. Substituting another antidepressant may also worsen symptoms of depression. Because of the complexity and uncertainties involved it is important that you ask your doctor to guide you to make decisions that are best for you and your baby.

Alternatives to Zoloft in Pregnancy

Zoloft was developed as a potential safer and better tolerated antidepressant with fewer side effects than Prozac and other older SSRIs. The women in the studies mentioned took different SSRIs and there were not enough patients on each one to draw any conclusions about the risks to the fetus from a specific SSRI. Therefore it is impossible to recommend one over the other.

Depending on the severity of your depression you and your doctor might decide that you are safe to stop Zoloft before or after you get pregnant. If you decide to stop you might benefit from psychotherapy and supportive group therapy through the pregnancy. This is a decision you and your doctor should make together. Exercise is also a known mood elevator so explore the safety and benefit of it to your individual situation with your doctor. Make certain you eat healthy foods and drink enough healthy fluids.

Avoid over-the-counter herbal or so-called natural medicines. These are not of any proven benefit and can be even more harmful for your baby than Zoloft.

Consider Your Baby and Yourself

It is best to take as few medications as possible during pregnancy. However if you are taking a necessary medication the struggle between protecting your baby and treating your medical problem adequately can be challenging. Armed with as much information as possible, you can have a meaningful discussion with your doctor.

Ask your doctor a lot of questions so you can understand all the issues being considered. It is a good thing to make sure your partner is present so he can hear the discussion first hand and ask his own questions and help you make the best decision. Feel free to get a second opinion if you are uncertain of the information or the decisions and you need further clarification.

Take all the necessary steps ahead of time to keep you and your baby healthy and safe during and after pregnancy. Also be aware that Zoloft is secreted in breast milk, so that is another area of concern.

Additional Information on Zoloft

For more information on Zoloft you can read the Medication Guide on the FDA website. Other helpful information is available through a National Institutes of Health (NIH) report that sorts through the collection of studies on the use of SSRIs in pregnancy and reach a consensus opinion. It is written jointly by the American Psychiatric Association (APA) and the American College of Obstetricians and Gynecologists (ACOG). It is a very technical bulletin but is full of information to discuss with your doctor.

If you are taking Zoloft and you or your baby have an adverse side effect or outcome you can report this to the FDA Drug Adverse Event Reporting Program online or call 1-800-332-1088.

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