Question

A 38-year-old G0 presents for a preconception evaluation. She has a history of long-time anxiety and depression, and is interested in continuing her medications in pregnancy, which includes sertraline (Zoloft). In what FDA pregnancy category is this drug?

A. Category A
B. Category B
C. Category C
D. Category D
E. Category X

Answer 1

Sertraline (Zoloft), an SSRI used to treat depression and generalized anxiety disorder, was previously categorized as FDA Pregnancy Category C, indicating potential risks that could not be ruled out. The FDA has since updated drug labeling requirements to provide more nuanced guidance for pregnant women.

Step-by-step explanation:

The FDA pregnancy category for sertraline (Zoloft) was previously considered Category C before the FDA replaced the previous letter categorization system with updated drug labeling rules in 2015 that require manufacturers to provide more detailed information regarding the risks of using a drug during pregnancy and lactation. While under the old system, Category C indicated that risk to the fetus could not be ruled out, healthcare professionals should now consult the new labeling and individual drug data to assess the benefits and risks of sertraline during pregnancy. Sertraline is a Selective Serotonin Reuptake Inhibitor (SSRI), a class of drugs that includes medications such as fluoxetine (Prozac), citalopram (Celexa), and paroxetine (Paxil), commonly used to treat conditions like depression and generalized anxiety disorder.