Pregnant Woman In Pink Sundress

Answer

Effexor (Venlafaxine) is classified as FDA pregnancy risk category C.

Pregnancy categories include:

  • A
  • B
  • C
  • D
  • X

Level A is considered to be safe while level X is considered to be a significant risk.

Category C, which is where venlafaxine is classified, essentially means there are either no studies or there are conflicting studies on the possible effects.

The prescribing information for Effexor XR states the following:

"There are no adequate and well-controlled studies in pregnant women. Effexor XR should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed."

The prescribing information further states that, in rat studies, no fetal malformations were noticed but there was a decrease in birth weight and an increase in stillborn pups. It is important to remember that you can't always correlate results found in animal studies to what will occur in humans.

The general recommendation is that alternative drugs/therapies should be considered and venlafaxine should be used in pregnancy only when the benefit to the mother clearly outweighs any potential risk to the fetus.

While there are no studies directly looking at venlafaxine and pregnancy, it is known that newborn babies that are exposed to antidepressants have developed complications that have required hospitalization.

Complications potentially include:

  • Respiratory distress
  • Temperature instability
  • Feeding difficulty
  • Vomiting
  • Hypoglycemia
  • Constant crying

The 'Guidelines for the Treatment of Major Depressive Disorder' discusses the use of antidepressant therapy during pregnancy extensively, but they specifically note more studies are needed on the matter.

Two excerpts from these guidelines I believe are especially pertinent:

Overall, risk of teratogenicity with antidepressants following first trimester exposure appears to be low, although some rare birth defects have been observed to occur at higher rates with use of specific SSRIs.

Additionally:

With late pregnancy antidepressant use, some but not all studies show a risk of medical complications such as prematurity and a transient neonatal withdrawal/adaptation syndrome (761, 764). The syndrome in the neonate appears to be associated with antidepressant use in the third trimester, has been reported in babies exposed in utero to TCAs and SSRIs, and includes transient symptoms such as jitteriness, tremor, difficulty with feedings, and other symptoms.

The overall point is that you need to have a discussion with your doctor regarding whether or not antidepressant use offers the best course of therapy for your particular situation.

The benefits of the drug need to be weighed against the risks to the fetus and the risk of untreated/inadequately treated depression such as increased suicide risk, inability to engage in appropriate personal or obstetrical care, etc...


Summary

  • Venlafaxine is classified in pregnancy category C, meaning there are no adequate and controlled studies in humans.
  • Antidepressant use in general has been associated with certain risks and you should speak with your doctor regarding the best course of therapy for your particular situation.

  • References
    1. Effexor XR Prescribing Information. Pfizer
    2. Treatment Guidelines for Major Depressive Disorder. Psychiatry Online
    3. Antidepressant Use During Pregnancy: Current Controversies and Treatment Strategies. PubMed