Women who take the antidepressant Cymbalta (duloxetine) during pregnancy may be more likely to have a baby with a birth defect. The problem is that many pregnant women were not aware of this risk.
Cymbalta and Birth Defects
Cymbalta is an antidepressant medication in a class of drugs called SNRIs, or serotonin-norepinephrine reuptake inhibitors. This class of drugs also includes Pristiq (desvenlafaxine) and Effexor (venlafaxine). Unfortunately, all of these drugs have been shown to increase the risk of pregnancy complications and birth defects.
Cymbalta is Pregnancy Category C
Studies of Cymbalta in animals (rats and rabbits) have shown that it can cause harm to a developing fetus. However, studies in humans are inconclusive. Therefore, Cymbalta is a Pregnancy Category C, meaning that the FDA allows it to be prescribed to a pregnant woman if the benefit of treating depression outweighs the risk of birth defects.
Studies of Cymbalta Birth Defects
In February 2013, the International Journal of Medical Sciences published a study linking Cymbalta to adverse pregnancy outcomes, including birth defects. These risks include:
- Congenital abnormalities (birth defects)
- Spontaneous abortion
- Premature or post-term birth
- Ectopic pregnancy
- Neurobehavioral defects
Studies of Other SNRI Antidepressants and Birth Defects
In January 2013, researchers published a study linking Effexor (venlafaxine) to an increased risk of many birth defects. Researchers analyzed data on nearly 20,000 women who took Effexor during pregnancy between 1997 and 2007, and they found higher risks of the following birth defects:
- Atrial septal defect (ASD)
- Cleft palate
- Coarctation of the aorta
Cymbalta and Persistent Pulmonary Hypertension of the Newborn (PPHN)
Antidepressants in the SSRI class (such as Prozac, Zoloft, Celexa, etc.) have been associated with up to a 6-fold increased risk of Persistent Pulmonary Hypertension of the Newborn (PPHN). The FDA issued a Drug Safety Communication about the risk in 2011.
PPHN is a complication that occurs during the birthing process. In order for a baby to start breathing independently after birth, blood pressure in the lungs normally drops 10-fold and blood fills vessels in the lungs. In babies with PPHN, blood pressure in the lungs does not drop, and when the baby breaths, oxygen does not transfer to blood. This causes very low oxygen levels, which can lead to brain damage or death.