Norpramin

THE SAFETY OF DESIPRAMINE 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:

There is limited and inconclusive information available on the safety of desipramine during pregnancy. 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 is desipramine?

Desipramine is a tricyclic antidepressant (TCA), and is used to treat symptoms of major depression in adults and children. Desipramine is available as a brand (Norpramin™) or generic medication. Desipramine is available as an oral tablet, and requires a prescription from your doctor. 

What is desipramine used to treat?

Desipramine is used to treat major depression. Desipramine is also used for many off-label medical conditions including diabetic neuropathy, bulimia nervosa, and irritable bowel syndrome. In children over 5 years of age, desipramine has also been used for attention deficit hyperactivity disorder (ADHD).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 for at least a 2-week period of time. Episodes of major depression will usually occur more than once during a lifetime. 

You can learn more about depression during pregnancy here. You can also learn about treatments for depression here. Moms can also experience postpartum depression after the baby is born. You can read about postpartum depression here and ways to prevent postpartum depression here.

How does desipramine work?

Desipramine works 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 working, 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 desipramine, can it harm my baby?

There is limited information on the safety of desipramine 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 maternal use during pregnancy. A tricyclic antidepressant related to desipramine is imipramine, which has been associated with birth defects in some studies following first trimester exposure; however, no definitive pattern of birth defects has been associated with this medication. 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:

A study in Michigan Medicaid participants found 1 in 31 (3.2%) newborns exposed to desipramine were born with a birth defect, showing no increase in risk compared to the general population. 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 (for example, 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). A small study found no difference in behavior or cognitive function between children who were and children who were not exposed to desipramine in utero.

Studies have looked at the risk of other complications associated with tricyclic antidepressant use during pregnancy. 

  • 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 such as desipramine near the time of labor and delivery or afterwards is associated with an increased risk of neonatal withdrawal symptoms including jaundice, irritability, jitteriness, low blood sugar, respiratory, and central nervous system issues.

The American College of Obstetricians and Gynecologists recommend that depression treatment be individualized during pregnancy. It is important to weigh the risks versus benefits of medication use during pregnancy. In women who choose to discontinue desipramine therapy during pregnancy, the medication can be restarted after delivery.      

Bottom line: There is limited safety information available on the use of desipramine during pregnancy. For the entire class of tricyclic antidepressants, there is no conclusive evidence of 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 desipramine and become pregnant, what should I do?

If you are taking desipramine 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 desipramine, can I safely breastfeed my baby?

Desipramine is excreted into breast milk. There have been no reports of adverse effects in infants exposed to desipramine while nursing. Exercise caution if administering desipramine in women breastfeeding infants. Nursing infants should be monitored for signs of adverse events. The American Academy of Pediatrics classifies tricyclic antidepressants such as desipramine as a possible concern.

Bottom line: The effects of desipramine on nursing infants is
unknown. Caution is advised when nursing babies are exposed to tricyclic antidepressants.

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

One laboratory study found desipramine use may decrease sperm motility. There have been reports of desipramine causing decreased libido as well as erectile dysfunction and testicular pain in males.

If I am taking desipramine, what should I know?

There is no conclusive evidence of an increased risk of birth defects with desipramine use during pregnancy. It is important to weigh the risks versus benefits of taking this medication during pregnancy.

The effects of desipramine on nursing infants are unknown. Caution is advised if taking desipramine while breastfeeding.

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

This report provides a summary of the available information about the use of desipramine 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 desipramine 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

Mayo Clinic: Depression (major depressive disorder)

U.S. Food and Drug Administration:  Norpramin Prescribing Information

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.