Improving the Safety Infrastructure

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

In recent years, there have been numerous calls for a major revision of the FDA’s safety division originating from the professional and lay press.


IMPROVING THE SAFETY INFRASTRUCTURE

In recent years, there have been numerous calls for a major revision of the FDA’s safety division originating from the professional (Ray and Stein, 2006; Wood, Stein and Woosley, 1998; Avorn, 2005a) and lay press. Many critics fail to see the rationale for continued primary reliance on the MedWatch system as a safety warning system. Its limitations include limited voluntary reporting, incomplete data and lack of a reliable patient-based denominator from which to assess rates of AEs. Moreover, the absence of regular national reporting of medication exposure data from administrative claims or electronic clinical records is puzzling in view of the opportunity such data would provide to generate exposure data for potential safety studies at minimal costs.

AE reporting in psychotropic drug clinical trials for children has been severely criticized as inade-quate (Greenhill et al., 2001). Mainly, there is no consistency in terminology, method of elicitation of unwanted effects and reporting in published trials of AEs.

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