Popular Antidepressant Among Pharmaceutical Drugs With Labeling Updates

Cymbalta, a popular antidepressant medication is among the more than 90 entries of drugs with safety-related labeling changes released this month, so far, by the FDA.

FDA-approved in 2004, Cymbalta (a duloxetine delayed-release capsule) is indicated to treat Major Depressive Disorder, Generalized Anxiety Disorder, Diabetic Peripheral Neuropathic Pain, Fibromyalgia and Chronic Musculoskeletal Pain.

The drug comes with the FDA’s most serious warning, or black boxed warning, to alert people that taking this medication may increase the risk of “suicidal thoughts and behaviors” in children, adolescents and young adults.

Cymbalta is a serotonin and norepinephrine reuptake inhibitor (SNRI).

The labeling change released this month included this statement related to increased risk of bleeding:

  • “A post-marketing study showed higher incidence of postpartum hemorrhage in mothers taking duloxetine. Other bleeding events related to SSRI and SNRI use have ranged from ecchymoses, hematoma, epistaxis, and petechiae to life-threatening hemorrhages. Concomitant use of aspirin, non steroidal anti-inflammatory drugs (NSAIDs), warfarin, and other anti-coagulants may add to this risk.”

The labeling updates also encouraged healthcare providers to inform patients of key safety risks, including specific updates related to pregnant women. Cymbalta has been linked to maternal adverse reactions and fetal/neonatal adverse reactions.

Pregnant women exposed to Cymbalta were advised specifically on how to register into the Cymbalta Pregnancy Registry (a research study being managed by the drug’s manufacturer, Eli Lilly, to monitor the health of certain prescribed patients), given the serious safety concerns observed from research conducted since the drug has been on the market.

To register in the Cymbalta Pregnancy Registry, call 1-866-814-6975 or visit www.cymbaltapregnancyregistry.com.

To review the full product label for Cymbalta or to learn more about the specific labeling updates, visit https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm