Duloxetine During Pregnancy

Depression is the most frequently diagnosed mental health condition and can be triggered or worsened by the change in hormones during pregnancy. Duloxetine, or more frequently called Cymbalta, is a medication used to treat both depression and anxiety.

As depression is diagnosed more commonly in women, particularly during pregnancy, it is common to question if it is safe to take duloxetine during pregnancy. If you are struggling with depression, it is important to talk to your health care provider about options for managing your care.

Duloxetine During Pregnancy

  • Brand name: Cymbalta
  • Manufacturer: Eli Lilly

Therapeutic Effect:

Cymbalta is used to treat or manage the following:

  • Major depressive disorder
  • Generalized anxiety disorder – Generalized Anxiety Disorder is defined by the DSM-IV as excessive anxiety and worry on more days than not, for at least 6 months.
  • Neuropathic pain associated with diabetic peripheral neuropathy
  • Fibromyalgia

Pregnancy Safety Rating: Category C

Pregnancy Recommendation: Human data suggest there may be risk in the third trimester.

Duloxetine Side Effects:

  • Rare (4%-2%): Blurred vision, anxiety, decreased libido, erectile dysfunction, delayed or failed ejaculation, anorgasmia, hot flashes.

Pregnancy/Lactation Considerations: Duloxetine may have negative effects on the newborn, such as feeding challenges, continual crying, irritability, and hyperreflexia. It is unknown if this medication is distributed in breast milk. Breastfeeding is not recommended for mothers taking duloxetine.

Pregnancy Summaries:

The following summary is cited directly from Briggs, Freeman, & Yaffe.

Briggs, Freeman, & Yaffe – Duloxetine causes developmental toxicity in animals (growth restriction in rats and rabbits; behavior deficits and death in rats) at doses of 60 mg/day based on BSA (MRHD). No structural anomalies were observed in these species. The human data for duloxetine are limited and incomplete.

However, the pharmacologic action of duloxetine is similar to that of venlafaxine and selective serotonin reuptake inhibitors (SSRIs). SSRIs and venlafaxine have been associated with developmental toxicities, including spontaneous abortions, low birth weight, prematurity, neonatal serotonin syndrome, neonatal behavioral syndrome (withdrawal), possible sustained abnormal neurobehavior beyond the neonatal period, respiratory distress, and persistent pulmonary hypertension of the newborn (PPHN).

Some of these symptoms are thought to be consistent with a direct toxic effect, drug discontinuance syndrome, or a serotonin syndrome. If duloxetine is used in pregnancy, health care professionals are encouraged to call the toll-free number (800-670-6126) for information about patient enrollment in the Motherisk study.

Next Steps:

The American Pregnancy Association does not prescribe medication, nor do we serve as a consult for medication use during pregnancy.  It is imperative that you discuss the use of any medication during pregnancy with your health care provider.

The purpose of this document is to provide you with information to support discussions with your health care provider.

Sources:

Hudgson, Barbara and Kizior, Robert, Saunders Nursing Drug Handbook 2012, Elsevier, St. Louis, MO. ISBN: 978-1-4377-2334-2.

Briggs, Gerald, Freeman, Roger and Yaffe, Sumner, Drugs in Pregnancy and Lactation, 9th Ed., Wolters Kluwer/Lippincott Williams & Wilkins, Philadelphia, PA. ISBN: 978-1-60831-708-0, 2011.

Physicians’ Desk Reference (PDR), PDR Network, LLC, Motvale, NJ 07645 ISBN: 978-1-56363-780-3