Depression Home > Fetzima and Pregnancy

In animal studies involving Fetzima (levomilnacipran) and pregnancy, the antidepressant was shown to cause reduced fetal body weights and delayed fetal bone development. However, it can still be given to a pregnant woman if her healthcare provider believes that the benefits outweigh the risks. Untreated depression can affect pregnancy too, so discuss your unique situation with your healthcare provider.


Can Pregnant Women Take Fetzima?

Fetzima™ (levomilnacipran) is a prescription medication approved to treat a type of depression known as major depressive disorder, also called clinical depression or simply major depression. Fetzima may not be safe for use during pregnancy, although the full risks are not yet known.

What Is Pregnancy Category C?

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Fetzima is classified as a pregnancy Category C medication.
Pregnancy Category C is given to medicines that have not been studied in pregnant humans but appear to cause harm to the fetus in animal studies. Medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Fetzima has not been adequately studied in pregnant women. In animal studies, the drug did not cause birth defects when given in high doses to pregnant rats or rabbits. It did reduce fetal body weights in the rats and delayed fetal bone development in both the rats and rabbits. When given to rats at five times the maximum human dosage during pregnancy and while the rats were breastfeeding, Fetzima interfered with weight gain in the newborn rats and increased the risk that the newborn rats would not survive.
However, it is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine, including Fetzima, may be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.
Antidepressants can cause problems in newborns when used by women during the third trimester of pregnancy (the last three months). These problems can happen immediately after birth and could lead to a longer-than-usual hospital stay. Such problems may include but are not limited to:
  • Serious breathing problems
  • A bluish skin color, indicating there is not enough oxygen in the blood
  • Body temperature changes
  • Feeding problems
  • Irritability
  • Jitteriness
  • Constant crying
  • Vomiting
  • Low blood sugar levels (hypoglycemia)
  • Low muscle tone
  • Muscle stiffness
  • Overactive reflexes
  • Tremors
  • Seizures.
It is also important to note that stopping antidepressants during pregnancy could cause your depression to return. However, untreated depression has its own problems that can affect pregnancy. Depression during pregnancy has been associated with low fetal birth weight. Major depression can also make it difficult to care for yourself during pregnancy and for your newborn child once you are no longer pregnant.
It is very important that you seek treatment if you think you may be depressed during pregnancy. Several treatments are available, including therapy (counseling) and medications. The decision about which treatment to use is a highly individual one. Your healthcare provider can help you weigh the pros and cons of all available treatments to find the one that fits your individual needs best.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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