Cymbalta and Pregnancy: An Overview
Cymbalta® (
duloxetine hydrochloride) is a pregnancy Category C medicine, meaning that Cymbalta may not be safe for use in pregnant women.
Cymbalta and Pregnancy Category C
The U.
S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medicines that show side effects to the fetus in animal studies, but no human studies in pregnant women have been done. A pregnancy Category C medicine may still be given to pregnant women if the healthcare provider believes that the benefits to the pregnant woman outweigh the possible risks to the unborn child.
In animal studies, when rabbits were given Cymbalta during early pregnancy, the baby rabbits weighed less. When rats were given Cymbalta during pregnancy and breastfeeding, the baby rats weighed less and were less likely to survive. In humans, there have been reports of problems in newborn babies born to mothers who were taking medications similar to Cymbalta. These problems can be as minor as irritability or as serious as
seizures or lung problems.
It is important to note that
depression in the mother may also not be healthy for a baby. Therefore, Cymbalta may be given to pregnant women if the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.