Recent FDA Actions and Consequences

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Chapter: Pharmacovigilance: The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors for the Treatment of Depression in Children and Adolescents

Drug exposure data are typically based on preva-lence estimates which are based on exposed youth rather than prescription sales, and this distinction is critical to a refined understanding of the impact of warnings on the use of prescribed ATDs in youth.


RECENT FDA ACTIONS AND CONSEQUENCES

Drug exposure data are typically based on preva-lence estimates which are based on exposed youth rather than prescription sales, and this distinction is critical to a refined understanding of the impact of warnings on the use of prescribed ATDs in youth. Since the heightened media coverage of treatment-emergent suicidality – which began in June 2003 – the prescription sales of SSRIs for the treatment of youth have dropped (Elias, 2005; Rosack, 2005).

The drop in prescription sales varied sizably with the age of the youth. In the Medco Health Systems report on prescription rate analyses from 2003–05 ATD prescriptions dropped 32% for youth under age 12 and 18% for youth aged 12–18 (Elias, 2005). Among youth with a diagnosis of depression, there was a 23% decrease in ATD prescriptions for those less than 18 in 2004 compared with the previous year (Pomerantz, 2005).

In a South Carolina Medicaid youth popula-tion ATD assessment covering the period May 2004 through April 2005, SSRI use decreased but TCAs and other ATDs increased (Narasimhan et al., 2005). In addition, the methodology for assess-ing change is critical. A recent study using Cana-dian insurance data defined new onset (incident) users of ATDs as those with a prescription follow-ing the diagnosis of depression. In this cohort of youth initially identified as diagnosed with depres-sion, SSRI treatment varied by race, gender, age, ATD subclass and medical provider (primary care or psychiatry). Being female, having a diagnos-ing general practitioner or pediatrician and having the same diagnosing and prescribing physician were associated with higher odds of receiving a SSRI (Sewitch et al., 2005). From these reports, it is clear that whether SSRI use is adversely affected by the FDA warnings should be based on more detailed information than prescription sales.

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