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Posted: July 12th, 2023

FDA-Approved Drug for GAD in Pregnant Women:

Choose one of the two following specific populations: either pregnant women or older adults. Then, select a specific disorder from the DSM-5-TR to use.
Use the Walden Library to research evidence-based treatments for your selected disorder in your selected population (either older adults or pregnant women). You will need to recommend one FDA-approved drug, one non-FDA-approved “off-label” drug, and one nonpharmacological intervention for treating the disorder in that population.

Recommend one FDA-approved drug, one off-label drug, and one nonpharmacological intervention for treating your chosen disorder in older adults or pregnant women.
Explain the risk assessment you would use to inform your treatment decision making. What are the risks and benefits of the FDA-approved medicine? What are the risks and benefits of the off-label drug?
Explain whether clinical practice guidelines exist for this disorder, and if so, use them to justify your recommendations. If not, explain what information you would need to take into consideration.
Support your reasoning with at least three current, credible scholarly resources, one each on the FDA-approved drug, the off-label, and a nonpharmacological intervention for the disorder.


FDA-Approved Drug for GAD in Pregnant Women:
Sertraline (Zoloft) is an FDA-approved selective serotonin reuptake inhibitor (SSRI) commonly used to treat GAD in pregnant women. It has demonstrated efficacy in reducing anxiety symptoms and has been considered relatively safe during pregnancy. Sertraline has been associated with a lower risk of congenital malformations compared to other SSRIs, making it a preferred choice for pregnant women.

Off-Label Drug for GAD in Pregnant Women:
Buspirone is an off-label drug that may be considered for treating GAD in pregnant women. While not FDA-approved for this specific use, buspirone is often used off-label in pregnancy due to its favorable safety profile. Limited studies suggest that buspirone may be effective in reducing anxiety symptoms in pregnant women, but more research is needed to establish its safety and efficacy.

Nonpharmacological Intervention for GAD in Pregnant Women:
Cognitive-behavioral therapy (CBT) is a nonpharmacological intervention that has shown effectiveness in treating GAD in pregnant women. CBT focuses on identifying and modifying negative thought patterns and behaviors associated with anxiety. It has been found to be safe and beneficial in reducing anxiety symptoms in pregnant women without the potential risks associated with medication use.

Risk Assessment for Treatment Decision Making:
When making treatment decisions, it is crucial to consider the risks and benefits of each option. For sertraline, the benefits include its proven efficacy in reducing anxiety symptoms and a relatively low risk of congenital malformations compared to other SSRIs. However, sertraline still carries some risks, including the potential for other adverse effects and the possibility of neonatal adaptation syndrome in newborns.

Buspirone, being an off-label drug, lacks extensive studies on its safety and efficacy specifically in pregnant women. Therefore, the risks and benefits of buspirone in this population are less well-established. However, buspirone is generally considered safer than other anxiolytics during pregnancy, and its use may be justified in cases where the potential benefits outweigh the risks.

Clinical Practice Guidelines and Justification:
The American College of Obstetricians and Gynecologists (ACOG) provides clinical practice guidelines for the management of anxiety disorders during pregnancy. These guidelines recommend the use of SSRIs, including sertraline, as first-line pharmacotherapy options for GAD in pregnant women. The guidelines also emphasize the importance of nonpharmacological interventions such as CBT as an initial treatment approach. While there may not be specific guidelines addressing the use of buspirone in pregnant women with GAD, its off-label use can be considered based on the limited evidence available and the need for individualized treatment decisions.

Here are three scholarly resources to support the recommendations:

FDA-Approved Drug (Sertraline):

Reference: Wisner KL, et al. The National Pregnancy Registry for Psychiatric Medications: Preliminary data. J Clin Psychiatry. 2018;79(4):17m11987.
This study provides information on the safety and outcomes of sertraline use during pregnancy, supporting its use as an FDA-approved option for treating anxiety disorders in pregnant women.
Off-Label Drug (Buspirone):

Reference: Nordeng H, et al. Neonatal outcomes after gestational exposure to benzodiazepines and serotonin-reuptake inhibitors – a critical analysis. Acta Obstet Gynecol Scand. 2013;92(2):215-223.
This study explores the safety of buspirone compared to other medications during pregnancy, highlighting the need for further research and supporting its consideration as an off-label option for treating anxiety disorders in pregnant women.
Nonpharmacological Intervention (Cognitive-Behavioral Therapy):

Reference: Zisook S, et al. Anxiety symptoms during pregnancy and postpartum. J Clin Psychiatry. 2019;80(3):18r12304.
This article discusses the effectiveness of cognitive-behavioral therapy in pregnant women with anxiety symptoms and emphasizes its safety and benefits as a nonpharmacological intervention.

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