What are the effects of gabapentin, fluoxetine (Prozac) and trazodone during pregnancy?

From the Guidelines

The use of gabapentin, fluoxetine (Prozac), and trazodone during pregnancy should be approached with caution, prioritizing the lowest effective dose and careful monitoring, as the potential risks to the fetus must be weighed against the benefits of treating the mother's mental health condition. When considering the effects of these medications during pregnancy, it is essential to evaluate the available evidence. According to a study published in Pediatrics in 2012 1, selective serotonin reuptake inhibitors (SSRIs) like fluoxetine are associated with a constellation of neonatal signs, including continuous crying, irritability, and feeding difficulty, which typically resolve within 1 to 2 weeks after birth.

Key Considerations

• Gabapentin has been associated with birth defects in animal studies, although human data is limited.
• Fluoxetine, an SSRI, has relatively reassuring safety data, but there is a small increased risk of cardiac defects and potential for neonatal adaptation syndrome if used late in pregnancy.
• Trazodone has less pregnancy data available, making it more challenging to assess its safety during pregnancy.

Recommendations

• Treatment decisions should be individualized through consultation with both a psychiatrist and obstetrician to weigh the mother's mental health needs against potential fetal risks.
• Women already taking these medications who become pregnant should not discontinue them abruptly without medical guidance, as sudden discontinuation could lead to withdrawal or worsening of underlying conditions.
• Regular monitoring throughout pregnancy is essential for women taking these medications, as it allows for the early detection of any potential issues and prompt intervention if necessary. In the context of real-life clinical medicine, prioritizing the mother's mental health while minimizing potential risks to the fetus is crucial. Therefore, the lowest effective dose of these medications should be used, and women should be closely monitored throughout their pregnancy.

From the FDA Drug Label

Use in Specific Populations 8. 1 Pregnancy Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. In nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic when administered to pregnant animals at doses similar to or lower than those used clinically. Prozac should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus Nonteratogenic EffectsNeonates exposed to Prozac and other SSRIs or serotonin and norepinephrine reuptake inhibitors (SNRIs), late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding.

The effects of gabapentin and fluoxetine (Prozac) on pregnancy are:

• Gabapentin: Developmentally toxic in nonclinical studies, and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Fluoxetine (Prozac): Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to Prozac may develop complications. There is no information about trazodone in the provided drug labels. 2 3

From the Research

Effects of Gabapentin on Pregnancy

• Gabapentin use during pregnancy has been associated with potential risks, including developmental toxicity and unknown birth impacts 4.
• A systematic review found that gabapentin exposure was associated with an increased risk of preterm birth, preeclampsia, small-for-gestational-age, and NICU admission 5.
• Another study found that among 294 first trimester gabapentin-monotherapy exposures, there were 5 major congenital malformations reported (1.7%), which is comparable to the rate in the general population 6.

Effects of Fluoxetine (Prozac) on Pregnancy

• Fluoxetine has been associated with negative outcomes, including significant malformations, PPHN, and PNAS, although the associations are not as strong as those with paroxetine 7.
• A review of the literature found that sertraline and citalopram should be first-line drug treatments for anxiety and depression in pregnant women, but fluoxetine may also be considered 7.
• Another study found that depressed SSRI-treated pregnant women, including those taking fluoxetine, and their children may be at increased risk for several complications, although the absolute risk is small 8.

Effects of Trazodone on Pregnancy

• There is no direct evidence available in the provided studies regarding the effects of trazodone on pregnancy.

General Considerations

• The use of any medication during pregnancy should be carefully evaluated, considering the potential benefits and risks to both the mother and the fetus 4, 5, 7, 8, 6.
• Well-controlled, prospective research studies are needed to determine the extent of the risks and benefits of prescribed and nonprescribed medication exposure to pregnant people and their neonates 4, 5.