THIS MEDICATION CAN CAUSE HARM TO YOUR BABY:
Certain tricyclic antidepressants such as clomipramine may be associated with an increased risk of harming developing babies. Tricyclic antidepressants are associated with an increased risk of neonatal withdrawal symptoms. Caution is advised if continuing this medication during pregnancy or while nursing a baby.
What are tricyclic antidepressants?
Tricyclic antidepressants (TCAs) are medications used to treat symptoms of major depression as well as many other conditions off-label. Types of tricyclic antidepressants that are available include amitriptyline, nortriptyline (Pamelor), amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), maprotiline (Teva-Maprotiline), protriptyline, and trimipramine (Surmontil). To use any of the available tricyclic antidepressants, you must have a prescription from your doctor.
What are tricyclic antidepressants used to treat?
Tricyclic antidepressants are used to treat major depression, headache, fibromyalgia, neuropathic pain, and sleep disorders. The safety of tricyclic antidepressants during pregnancy has not been studied as much as other antidepressant medications such as selective serotonin reuptake inhibitors (SSRIs).
What is major depression?
Major depression is a type of mood disorder causing feelings of sadness, hopelessness, decreased energy, irritability, and/or loss of interest in daily activities daily for at least a 2-week period of time. Episodes of major depression will usually occur more than once during a lifetime.
How do tricyclic antidepressants work?
Tricyclic antidepressants work by increasing the presence of the neurotransmitters serotonin and norepinephrine in the brain. Tricyclic antidepressants are most effective when started at a low dose that is slowly increased until an effective dose is achieved. In order to ensure that a dose of tricyclic antidepressant is effective, it must be taken for 6 to 12 weeks before its effectiveness can be evaluated. Tricyclic antidepressants are usually taken once daily at bedtime (to avoid drowsiness), but can be divided into multiple smaller doses to be taken throughout the day.
If I am taking a tricyclic antidepressant, can it harm my baby?
There is limited information on the safety of tricyclic antidepressant use during pregnancy. As a class of medications, tricyclic antidepressants have not been conclusively proven to be associated with an increased risk of birth defects. However, certain tricyclic antidepressants such as clomipramine may pose an increased risk of birth defects with use during pregnancy. It is important to consider the risks and benefits of this medication before taking it during pregnancy and to also consider the risks of untreated major depression or other conditions requiring tricyclic antidepressant use.
Evidence:
Comparative studies of women who took tricyclic antidepressants during pregnancy versus women who did not show similar risks of birth defects, particularly heart defects, between both types of women. One large national registry study compared 1,600 women who took a tricyclic antidepressant (ex. clomipramine) during pregnancy to women who did not (n=1,000,000), finding women who took clomipramine had an increased risk of birth defects, specifically, heart defects, compared to the women in the control group. The Quebec Pregnancy Cohort study included 18,000 pregnant women with first trimester exposure to antidepressants. Tricyclic antidepressant exposure was associated with an increased risk of facial and digestive birth defects. The Swedish Medical Birth Register study found that tricyclic antidepressants were associated with an increased risk of birth defects and persistent pulmonary hypertension of the newborn (PPHN).
Various studies have looked at the risk of other complications associated with tricyclic antidepressant use during pregnancy and found:
- Miscarriage: a large national registry study found no increased risk
- Preeclampsia: at least 2 studies found an increased risk during the 2nd and 3rd trimesters
- Postpartum hemorrhage: a national study failed to prove a significant increase in risk during the 2nd and 3rd trimesters; however, antidepressants are associated with an increased risk of bleeding
- Preterm birth: a review of several studies found no increased risk
- Neurobehavioral development (ex. ADHD): studies have found no increased risk
Tricyclic antidepressants are commonly associated with neonatal complications. The use of tricyclic antidepressants near the time of labor and delivery or afterwards is associated with an increased risk of neonatal withdrawal symptoms including jaundice, low blood sugar, respiratory, and central nervous system issues.
Bottom line: There is limited safety information available on the use of tricyclic antidepressants during pregnancy. For the entire class of tricyclic antidepressants, there is no conclusive evidence of an increased risk of birth defects. However, certain tricyclic antidepressants such as clomipramine may be associated with an increased risk of birth defects. It is important to weigh the risks versus benefits of taking this medication during pregnancy.
If I am taking a tricyclic antidepressant and become pregnant, what should I do?
If you are taking a tricyclic antidepressant and become pregnant, you should contact your doctor immediately. Your doctor will determine if your medication is medically necessary, or if it should be discontinued until after the birth of your baby.
If I am taking a tricyclic antidepressant, can I safely breastfeed my baby?
The effects of tricyclic antidepressants on nursing infants is unknown. Exercise caution if administering tricyclic antidepressants to women who are breastfeeding infants. The American Academy of Pediatrics classifies tricyclic antidepressants such as nortriptyline, doxepin, and amitriptyline as a possible concern.
Bottom line: The effects of tricyclic antidepressants on nursing infants is unknown. Caution is advised when nursing babies are exposed to tricyclic antidepressants.
If I am taking a tricyclic antidepressant, will it be more difficult to get pregnant?
The effects of tricyclic antidepressants on fertility is unknown.
If I am taking a tricyclic antidepressant, what should I know?
For the entire class of tricyclic antidepressants, there is no conclusive evidence of an increased risk of birth defects. However, certain tricyclic antidepressants such as clomipramine may be associated with an increased risk of birth defects. It is important to weigh the risks versus benefits of taking this medication during pregnancy.
The effects of tricyclic antidepressants on nursing infants are unknown. Caution is advised if taking tricyclic antidepressants while breastfeeding.
If I am taking any medication, what should I know?
This report provides a summary of available information about the use of tricyclic antidepressants during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.
You may find Pregistry's expert reports about mental health disorders and the individual medications used to treat mental health disorders here. Additional information can also be found in the resources below.
For more information about tricyclic antidepressants during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following links:
National Institute of Mental Health: Depression Basics
US Food and Drug Administration: Clomipramine Prescribing Information
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.