Health Canada: Cymbalta and the Risk of Postpartum Hemorrhage

The risk of postpartum hemorrhage has been included in the Warnings and Precautions and Patient Medication Information sections of the Canadian product monograph for Cymbalta.

Health Canada: The risk of postpartum hemorrhage has been included in the Warnings and Precautions and Patient Medication Information sections of the Canadian product monograph for Cymbalta.

  • An observational study evaluating the risks of maternal outcomes associated with exposure to duloxetine during pregnancy demonstrated an increased risk of postpartum hemorrhage for women exposed to duloxetine.
  • The risk of postpartum hemorrhage was 36/1000 (95% confidence interval: 24.8-49.4) in women exposed to duloxetine close to delivery (final 30 days of pregnancy) compared to 23/1000 (95% confidence interval: 23.1-23.4) in women who were not exposed to duloxetine during pregnancy (adjusted relative risk: 1.53 [95% confidence interval: 1.08-2.18]).
  • When treating a pregnant woman, the use of duloxetine close to labour and delivery should only be considered if the potential benefit justifies the potential risk to the fetus and the mother.

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