What are the risks of taking Effexor (Venlafaxine) during the first trimester of pregnancy?

From the Guidelines

Taking Effexor during the first trimester of pregnancy does not substantially increase the risk for neurodevelopmental problems such as ASD and ADHD, according to the most recent research 1. When considering the use of Effexor during pregnancy, it's essential to weigh the potential risks and benefits. The research suggests that intrauterine antidepressant exposure, including Effexor, does not substantially increase the risk for concerning neurodevelopmental problems -- ASD and ADHD 1. Some key points to consider:

• The risk of adverse birth outcomes, such as preterm birth and congenital malformation, should be considered, but the research to date provides reassurance that the risk is not substantially increased by antidepressant use during pregnancy 1.
• Children born to women who use antidepressants during pregnancy are exposed to several other risk factors, including having a mother with an indication for antidepressant treatment, which appear to be largely responsible for the increased occurrence of ASD and ADHD among children prenatally exposed to antidepressants 1.
• Experts recommend a stepped approach to treatment of depression during pregnancy, which includes monitoring, exercise, social support, and evidence-based treatment such as cognitive therapy and antidepressants 1.
• The American Psychiatric Association and the American College of Obstetricians and Gynecologists suggest that antidepressants may be a superior treatment option to psychotherapy for some women, particularly those with a history of severe suicide attempts or severe depression who have previously experienced symptom reduction with antidepressant treatment 1.
• The decision to continue or discontinue Effexor during pregnancy should be made in consultation with healthcare providers, weighing the risks of medication against the risks of untreated depression or anxiety, which can also negatively impact pregnancy outcomes. It's crucial to identify pregnant women who may need treatment and provide them with services to reduce the risk of offspring neurodevelopmental problems, including routine screening for depression with validated self-report screening measures 1.

From the FDA Drug Label

Venlafaxine did not cause malformations in offspring of rats or rabbits given doses up to 11 times (rat) or 12 times (rabbit) the maximum recommended human daily dose on a mg/kg basis, or 2. 5 times (rat) and 4 times (rabbit) the human daily dose on a mg/m2 basis. However, in rats, there was a decrease in pup weight, an increase in stillborn pups, and an increase in pup deaths during the first 5 days of lactation, when dosing began during pregnancy and continued until weaning. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed

The risks of taking Effexor (venlafaxine) during the first trimester of pregnancy include:

• Potential harm to the unborn baby: Although venlafaxine did not cause malformations in animal studies, the lack of adequate and well-controlled studies in pregnant women means that the risk to human fetuses cannot be ruled out.
• Decreased pup weight, increased stillborn pups, and increased pup deaths: Animal studies have shown these effects when dosing began during pregnancy and continued until weaning. It is recommended that venlafaxine be used during pregnancy only if clearly needed, and the benefits and risks of treatment should be carefully considered by the healthcare provider 2.

From the Research

Risks of Taking Effexor During Pregnancy First Trimester

• The study 3 found no statistically significant differences in the hazard of spontaneous abortion following gestational venlafaxine use compared with either antidepressant unexposed or SSRI exposed pregnancies.
• Another study 4 compared the effects of prenatal exposure to venlafaxine, selective serotonin reuptake inhibitors (SSRIs), and maternal depression on child neurodevelopment, and found that the children exposed to venlafaxine, SSRIs, and maternal depression during pregnancy had similar full-scale IQs.
• A study on rats 5 found that perinatal exposure to venlafaxine led to lower anxiety and depression-like behavior in the adult rat offspring, suggesting that prenatal and early postnatal exposure to venlafaxine may interfere with functional development of the brain.
• However, a study 6 found that venlafaxine was associated with multiple birth defects, including anencephaly and craniorachischisis, which persisted after partially accounting for underlying conditions.

Birth Defects and Effexor

• The study 6 found elevated associations between venlafaxine and multiple birth defects, including:
  • Anencephaly and craniorachischisis: aOR, 9.14; 95% CI, 1.91-43.83
• These findings suggest that venlafaxine may be associated with an increased risk of certain birth defects, although the results need to be confirmed given the limited literature on venlafaxine use during pregnancy and risk for birth defects.

Depression and Effexor

• A study 7 found that an exercise programme during pregnancy may reduce the prevalence of depression in late pregnancy and postpartum, highlighting the importance of managing depression during pregnancy.
• The study 4 found that depression during pregnancy is a significant risk factor for postpartum depression, and that children of depressed mothers may be at risk of future psychopathology.