What are the guidelines for using Prozac (fluoxetine) in a pregnant patient with bipolar disorder?

From the Guidelines

The use of Prozac (fluoxetine) during pregnancy in patients with bipolar disorder should be carefully considered, weighing the risks and benefits, and generally used with caution, only when the potential benefits outweigh the risks, as suggested by the most recent and highest quality study 1. When considering the use of Prozac in pregnant patients with bipolar disorder, it is essential to assess the severity of current symptoms, previous mental health history, and patient treatment preferences, as recommended by the American Psychiatric Association and the American College of Obstetricians and Gynecologists 1. Some key points to consider include:

• The potential risks associated with Prozac use during pregnancy, such as a small increased risk of cardiac defects when used in the first trimester, possible neonatal adaptation syndrome when used late in pregnancy, and a slight increased risk of postpartum hemorrhage 1.
• The importance of close monitoring during pregnancy, with regular appointments every 2-4 weeks to assess mood stability and medication response 1.
• The need for collaborative decision-making involving psychiatry, obstetrics, and the patient to ensure optimal management 1.
• The fact that untreated bipolar disorder during pregnancy carries significant risks, including relapse, poor prenatal care, substance use, and postpartum psychosis, which must be weighed against medication risks 1. It is also important to note that the research to date suggests that intrauterine antidepressant exposure does not substantially increase the risk for two concerning neurodevelopmental problems -- ASD and ADHD 1. Therefore, Prozac should be used at the lowest effective dose, typically in the range of 20-80 mg daily, with many pregnant patients maintained on 20-40 mg daily, and with careful consideration of the potential risks and benefits, as well as close monitoring and collaborative decision-making 1.

From the FDA Drug Label

Pregnancy Category C In embryo–fetal development studies in rats and rabbits, there was no evidence of teratogenicity following administration of up to 12.5 and 15 mg/kg/day, respectively (1.5 and 3. 6 times, respectively, the MRHD of 80 mg on a mg/m2 basis) throughout organogenesis. However, in rat reproduction studies, an increase in stillborn pups, a decrease in pup weight, and an increase in pup deaths during the first 7 days postpartum occurred following maternal exposure to 12 mg/kg/day (1.5 times the MRHD on a mg/m2 basis) during gestation or 7.5 mg/kg/day (0. 9 times the MRHD on a mg/m2 basis) during gestation and lactation. Prozac should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus Nonteratogenic Effects Neonates 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. Infants exposed to SSRIs in late pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN)

The guidelines for using Prozac (fluoxetine) in a pregnant patient with bipolar disorder are:

• Pregnancy Category C: Prozac should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Risk of complications: Neonates exposed to Prozac in late pregnancy may develop complications requiring prolonged hospitalization, respiratory support, and tube feeding.
• Risk of PPHN: Infants exposed to SSRIs in late pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN).
• Careful consideration: When treating a pregnant woman with Prozac during the third trimester, the physician should carefully consider both the potential risks and benefits of treatment 2.

From the Research

Guidelines for Using Prozac in Pregnant Patients with Bipolar Disorder

• The management of bipolar disorder in pregnancy is challenging due to the increased risk of relapse and the need to weigh the risks of untreated illness against potential treatment effects on the mother and fetus 3.
• There is limited evidence on the safety of psychotropic medication in pregnancy, including antidepressants like Prozac (fluoxetine) 3.
• Untreated bipolar disorder in pregnancy is associated with adverse maternal and neonatal outcomes, such as premature delivery and low birth weight 4.
• Mood stabilizers like lamotrigine and atypical antipsychotics may have a favorable safety profile in pregnancy, but there is limited information on the use of Prozac in this context 4.
• Discontinuing medication during pregnancy may increase the risk of recurrence, particularly in women with more severe and unstable bipolar disorders 5.
• A well-planned and slow discontinuation of medication before pregnancy may be recommended for more stable bipolar women, while close monitoring and prophylactic medication may be necessary for those with more severe conditions 5.
• Barriers to accessing pharmacotherapy during pregnancy include perceptions that psychiatric providers lack training and experience in treating psychiatric illness during pregnancy, and that pharmacotherapy is not needed 6.
• Facilitators of access to pharmacotherapy include providers' acknowledgment of the risks associated with untreated or undertreated psychiatric illness during pregnancy, and provision of psycho-education about the risks, benefits, and alternatives to pharmacotherapy 6.
• The management of bipolar disorder during pregnancy requires careful consideration of the risks and benefits of treatment, and larger studies are needed to clarify the risks of relapse and fetal medication exposure 7.