Women face difficult choices when deciding whether or not to continue psychiatric medications during pregnancy.  For many years, we have typically recommended the older antidepressants, including the selective serotonin reuptake inhibitors or SSRIs such as fluoxetine (Prozac), citalopram (Celexa), and sertraline (Zoloft), because we had the most robust data on reproductive safety data for these medications.

As time has moved along, we have seen more women taking some of these newer (but not so new anymore) antidepressants, and this increase in use has contributed to an increased body of knowledge regarding reproductive safety.  

Duloxetine (brand name Cymbalta) is increasingly used as a first line treatment for women with major depression, especially if there is comorbid fibromyalgia or neuropathic pain.  Duloxetine is also effective for the treatment of anxiety disorders which are common among women of reproductive age. Given its efficacy for a broad range of psychiatric disorders, its use has grown considerably since it was released in 2004.

We last reported on the use of duloxetine during pregnancy in 2015.  Since that time, no new reports have been published regarding the reproductive safety of duloxetine.  However, we have a fair amount of data on the use of duloxetine during pregnancy, coming from pooled data collected in large cohort studies.

Using the PRISMA guideline for systematic reviews, the authors performed a systematic search for the risk of major congenital malformations after first-trimester exposure to duloxetine. Eight cohort studies were identified, including a total of 668 infants exposed to duloxetine.

Researchers analyzed data from 668 duloxetine-exposed infants and observed 16 major malformations (2.33%), resulting in a relative risk estimate of 0.80 (95% confidence interval of 0.46-1.29).  The researchers did not have a specific unexposed control group but they estimated relative risk using a reference value of 3% for the prevalence of major malformations in the general population.

Based on these data, duloxetine exposure during the first trimester does not appear to increase risk of major malformations.  However, the number of duloxetine exposures is om the small side (668) compared to the thousands of exposures we have for some of the older SSRIs.  With regard to the use of duloxetine during pregnancy, it comes down to personal preference and an estimation of risk for illness recurrence in the setting of a medication switch.   Some women may choose to switch to another medication, feeling more comfortable to use a medication that has been around for a longer time. Others may not want to make any changes because they are well and acknowledge that switching to a different medication may increase their risk for relapse.  

The Bottom Line:  We have more information, and that is a good thing.  However, making decisions regarding the use of medication during pregnancy is never easy.  

For women currently taking or planning to take antidepressants (and other medications) during pregnancy, consider participating in the National Pregnancy Registry for Psychiatric Medications.  

The National Pregnancy Registry for Psychiatric Medications is dedicated to evaluating the safety of psychiatric medications such as antidepressants, ADHD medications, and atypical antipsychotics that many women take during pregnancy to treat a wide range of mood, anxiety, executive function, or psychiatric disorders. The goal of this Registry is to gather information on the safety of these medications during pregnancy, as current data is limited.

Ruta Nonacs, MD PhD

Lassen D, Ennis ZN, Damkier P.  First-trimester pregnancy exposure to venlafaxine or duloxetine and risk of major congenital malformations: a systematic review.  Basic Clin Pharmacol Toxicol. 2015 Oct 5.

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