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Psychotropic Medication Use Among Women Initiating Prenatal Care in the California Medicaid Program, ... - page 3 / 19

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Examples of Challenges and Dilemmas

Regulatory: No psychotropic drugs are currently approved by FDA for use in pregnancy (Lamberg, 2005).

Regulatory: FDA’s use-in-pregnancy categories may be confusing -- implies a gradation of risk that does not necessarily exist (Meadows, 2001).

Research: Ethical considerations limit drug research on pregnant women (Cott, 2003).

Research: Safety of psychotropic drugs in pregnancy is unresolved (Grover, 2006).

Clinical: Dilemma between fetal compromise and untreated mental illness – untreated conditions that may lead to poor adherence to care (Allison, 2004).

Clinical: Timing of exposure to psychotropic medications relative to the stage of pregnancy may affect the fetus differently – the 2nd to 8th week of post-fertalization is the critical period for structural birth defects (Ward, 2002).

Clinical: Different psychotropic medications can have a different effect on people based on ethnicity (Lin, 2001).

Epidemiology & Evaluation Section

Maternal, Child, & Adolescent Health Branch

California Department of Health Services

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