Zoloft

THE SAFETY OF SERTRALINE (ZOLOFT) DURING PREGNANCY OR BREASTFEEDING

The information provided below is for readers based in the United States of America. Readers outside of the United States of America should seek the information from local sources.

THIS MEDICATION CAN CAUSE HARM TO YOUR BABY:

Sertraline may be associated with increased risk to the developing baby during the third trimester of pregnancy.

What is sertraline?

Sertraline is an antidepressant known as a selective serotonin reuptake inhibitor (SSRI). 

What is sertraline is used to treat?

Sertraline is a prescription medication used to treat anxiety and depression.

How does sertraline work?

SSRIs such as sertraline increase the presence of the neurotransmitter serotonin in the brain, which can improve symptoms of depression and anxiety. 

If I am taking sertraline, can it harm my baby?

In some animal studies, doses of sertraline that were four times greater than recommended human doses led to no birth defects; however, additional animal studies showed delayed bone formation and an increased risk of stillbirths with sertraline exposure during the third trimester of pregnancy. Sertraline does cross the human placenta to reach the baby. Several large studies of women who took sertraline during pregnancy have found no difference in outcomes such as birth defects versus women not exposed to sertraline during pregnancy. Studies are mixed on whether or not sertraline exposure during the first trimester is linked to problems with skull development or heart defects. One study from 1999 found that exposure to sertraline during the third trimester increases the risk of premature birth, difficult newborn to infant transition, and need for special care. An additional study found an increased risk of autism with third trimester use of sertraline. In an interview of over 600 women, clubfoot was also been linked to second and third trimester use of sertraline.

A large review of several trials from 2006 found a significant increase in spontaneous abortions (miscarriages) in pregnancies with sertraline exposure. Sertraline exposure in the developing baby is also associated with some neurodevelopmental delay and possibly an increased risk of problems with oxygen delivery after birth. Neonatal behavioral syndrome is a possible side effect from sertraline use in late pregnancy. It is characterized by mild changes in neurologic, motor, respiratory, and gastrointestinal behaviors of the newborn that resolve within 2 weeks. Other studies have shown a link between in utero sertraline exposure and long-term neurobehavioral changes such as reduced pain response.

If I am taking sertraline and become pregnant, what should I do?

It is important that depression and anxiety therapy be individualized for each patient. The risks should be weighed against the benefits of continuing antidepressant therapy during pregnancy. Women who are attempting to conceive or become pregnant while on sertraline should speak with their doctor. Your doctor can always restart antidepressant therapy following delivery if it is discontinued during pregnancy.

If I am taking sertraline, can I safely breastfeed my baby?

Sertraline is excreted through the breast milk. An infant is exposed to 0.5% to 3% of the mother’s dose. No adverse events to the baby from sertraline exposure through breast milk have been reported, but it is unknown how exposure could affect long-term neurobehavioral development. Treatment of depression with SSRIs such as sertraline may be beneficial in some breastfeeding women. If a woman takes this medication while breastfeeding, her doctor may recommend stopping or decreasing the frequency of breastfeeding because of the unknown neurobehavioral effects. SSRIs have been associated with maternal interruption in lactation. Mothers taking sertraline and breastfeeding their babies should be monitored, and they may require breastfeeding support. If you need help with breastfeeding, please contact a lactation consultant. The American Academy of Pediatrics states that antidepressants such as sertraline pose some risk to the breastfeeding infant. If SSRIs are indicated in breastfeeding women, sertraline is usually a top choice.

If I am taking sertraline, will it be more difficult to get pregnant?

Sertraline and other SSRIs are associated with reduced sex drive and inability to orgasm, but it is unclear if this affects fertility.

If I am taking sertraline, what should I know?

It is important to speak with your doctor to determine if you should continue sertraline therapy during pregnancy. Sertraline should only be used during pregnancy if the benefits to the mother outweigh the risks to the developing baby. Exposure to sertraline during the third trimester of pregnancy may cause complications such as irritability and difficulty feeding in the newborn. The risk of birth defects is unknown. Breastfeeding mothers who are taking sertraline should monitor their baby for any adverse effects.

If I am taking any medication, what should I know?

This report provides a summary of available information about the use of SSRIs during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.

You may find Pregistry's expert report about depression here, reports about other mental health disorders here, and reports about the individual medications used to treat mental health disorders here.   Additional information can also be found in the resources below. 

For more information about sertraline during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following link:

Read the whole report
General information

It is very common for women to worry about having a miscarriage or giving birth to a child with a birth defect while they are pregnant. Many decisions that women make about their health during pregnancy are made with these concerns in mind.

For many women these concerns are very real. As many as 1 in 5 pregnancies end in a miscarriage, and 1 in 33 babies are born with a birth defect. These rates are considered the background population risk, which means they do not take into consideration anything about the health of the mom, the medications she is taking, or the family history of the mom or the baby’s dad. A number of different things can increase these risks, including taking certain medications during pregnancy.

It is known that most medications, including over-the-counter medications, taken during pregnancy do get passed on to the baby. Fortunately, most medicines are not harmful to the baby and can be safely taken during pregnancy. But there are some that are known to be harmful to a baby’s normal development and growth, especially when they are taken during certain times of the pregnancy. Because of this, it is important to talk with your doctor or midwife about any medications you are taking, ideally before you even try to get pregnant.

If a doctor other than the one caring for your pregnancy recommends that you start a new medicine while you are pregnant, it is important that you let them know you are pregnant.

If you do need to take a new medication while pregnant, it is important to discuss the possible risks the medicine may pose on your pregnancy with your doctor or midwife. They can help you understand the benefits and the risks of taking the medicine.

Ultimately, the decision to start, stop, or change medications during pregnancy is up to you to make, along with input from your doctor or midwife. If you do take medications during pregnancy, be sure to keep track of all the medications you are taking.