Pregnancy and Cymbalta/duloxetine

Most women who are pregnant want to do everything right for their baby, such as eating right, exercising regularly, and getting good prenatal care. But if you’re one of the many women who find themselves on an antidepressant and newly pregnant, you might be asking yourself a lot of questions.  

It’s common for doctors to tell women who are pregnant to stop taking drugs like antidepressants during pregnancy. This leaves many moms-to-be conflicted about how to stop their antidepressants without dealing with withdrawal effects from a rapid taper.

In an ideal world, one would safely taper off all antidepressants prior to attempting to get pregnant, but we don’t live in an ideal world.  With this in mind, we have compiled a list of the most updated articles for you to read to educate yourself on the pros, cons, and what-ifs of taking an antidepressant while pregnant.

If you are pregnant, due to the high risk of debilitating withdrawal, it might be wise to start your gradual taper immediately

It is essential to tell your doctor or obstetrician exactly what prescription and non-prescription medications you are taking, including any supplements.  It is encouraged to use a drug interaction checker to check all drugs for any adverse drug interactions.

Here are some links with information about pregnancy and antidepressants, including thoughts from the ever-compassionate Adam Urato, M.D.

Antidepressants and Pregnancy:  Who Says They Are Safe?  By Adam Urato M.D.

Chemicals Have Consequences—Antidepressants and Pregnancy: An Interview With Adam Urato, MD by James Moore
It’s a fantastic podcast! Adam Urato, MD, joins us to discuss what we do and don’t know about the effects of antidepressants on babies and mothers and the importance of counselling in order to aid families in making important decisions about pharmaceutical drug use.

Antidepressants and Pregnancy: Tips from an Expert – Weighing Your Risk by Lauren Osborne M.D

Health Risks to Babies When Antidepressants Used During Pregnancy   A new study in Psychological Medicine finds that babies born to mothers taking antidepressants were more than six times as likely to have neonatal withdrawal syndrome—including breathing problems, irritability/agitation, tremors, feeding problems, and seizures—than those born to mothers taking other types of drugs. More than 80% of the reported symptoms were classified as serious.

Mother To Baby Fact Sheet regarding Cymbalta

Levinson‐Castiel R, Merlob P, Linder N, Sirota L, Klinger G. Neonatal abstinence syndrome after in utero exposure to selective serotonin reuptake inhibitors in term infants. Arch Pediatr Adolesc Med 2006; 160: 173–6.  Conclusions: Neonatal abstinence syndrome occurs in 30% of neonates exposed to SSRIs in utero. These neonates should be monitored for at least 48 hours after birth. The long-term effects of prolonged exposure to SSRIs, particularly in neonates who develop severe symptoms, have yet to be determined.

Antidepressants, Infection Linked to Neurodevelopmental Disorders  Researchers Kristine Zengeler and John Lukens, PhD, have found that antidepressant use during pregnancy may combine with inflammation to up the risk of neurodevelopmental disorders.

Study Links Prenatal Antipsychotic Exposure to Developmental Delays and ADHD   “Our meta-analysis showed a significant association between prenatal exposure to antipsychotics and an increased risk of adverse outcomes in the child related to attention deficit hyperactivity disorder, social-emotional-mental development, and motor delay. Although we believe that the current data are insufficient to conclude that antipsychotics in the perinatal period cause increased morbidity, these results highlight that women receiving antipsychotic drugs in the perinatal period represent a population at higher risk for adverse outcomes for their children.”  (April 2, 2024)

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Cymbalta Package Insert

The most recent pharmaceutical insert for Cymbalta is dated August 2023.  The FDA keeps all updated data points on Cymbalta and they can be accessed here. 

These are a few key points regarding pregnancy and use of Cymbalta from the FDA:

• Pregnancy: Third-trimester use may increase the risk for symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, tremor, irritability) in the neonate (see insert 8.1)
• A post-marketing study showed a higher incidence of postpartum hemorrhage in mothers taking CYMBALTA. Other bleeding events related to SSRI and SNRI use have ranged from ecchymoses, hematomas, epistaxis, and petechiae to life-threatening hemorrhages. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, and other anti-coagulants may add to this risk.
• There is a pregnancy exposure registry that monitors the pregnancy outcomes in women exposed to antidepressants, including CYMBALTA, during pregnancy. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Antidepressants at 1-866-961-2388 or online at https://womensmentalhealth.org/research/pregnancyregistry/.
• Data from a postmarketing retrospective cohort study indicate that the use of duloxetine in the month before delivery may be associated with an increased risk of postpartum hemorrhage. Data from published literature and from a postmarketing retrospective cohort study have not identified a clear drug-associated risk of major birth defects or other adverse developmental outcomes (see Data). There are risks associated with untreated depression and fibromyalgia in pregnancy, and with exposure to SNRIs and SSRIs, including CYMBALTA, during pregnancy (see Clinical Considerations).
• The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
• Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants. This finding is from a prospective, longitudinal study that followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum.
• Pregnant women with fibromyalgia are at increased risk for adverse maternal and infant outcomes, including preterm premature rupture of membranes, preterm birth, small for gestational age, intrauterine growth restriction, placental disruption, and venous thrombosis. It is not known if these adverse maternal and fetal outcomes are a direct result of fibromyalgia or other comorbid factors.
• Maternal Adverse Reactions
  Use of CYMBALTA in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions (5.5)].
• Fetal/Neonatal Adverse Reaction
  • Neonates exposed to CYMBALTA and other SNRIs or SSRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These findings are consistent with either a direct toxic effect of the SNRIs or SSRIs or, possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see Warnings and Precautions (5.4)].
• Patient Counseling Information: Pregnancy
  • Advise women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with CYMBALTA.
  • Advise pregnant women or patients who intend to become pregnant that CYMBALTA may increase the risk of neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding.
  • Advise pregnant women that there is a risk of relapse with discontinuation of antidepressants.
  • Advise patients that a pregnancy exposure registry monitors pregnancy outcomes in women exposed to CYMBALTA during pregnancy [see Use in Specific Populations (8.1)].
  • Lactation ― Advise breastfeeding women using CYMBALTA to monitor infants for sedation, poor feeding and poor weight gain and to seek medical care if they notice these.

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Lived Experience Comments from Cymbalta Hurts Worse members:

“My daughter was on 30mg all through and now has a very chatty 2 year old. If you decide to stay on this drug throughout your pregnancy, print out a list of all drugs that interact. I am glad I did when we went to see the anesthetist, as there were some drugs that could be given if needed that interacted.” Cymbalta Hurts Worse Member

“Also, I cannot stress enough: it is really important that they know you are taking this drug – make them listen.”  Cymbalta Hurts Worse Member 

“I was worried sick, which is why I am a member of Cymbalta Hurts Worse and heard from a lot of mums when I asked about it.” Cymbalta Hurts Worse Member 

“The Drs wanted to change to another drug, but after researching, my daughter refused. I was relieved she stayed on Cymbalta, although the baby can get withdrawals. They will have to watch the baby. My grandson was ok, no reactions at all, but I do feel that may not be the case for everyone”.  Cymbalta Hurts Worse Member