Antidepressants and Suicide Risk: How Did Specific Information in FDA Safety Warnings Affect Treatment Patterns?

Abstract

Objective-From June 2003 through October 2004, the Food and Drug Administration (FDA) released five safety warnings related to antidepressant use and increased suicide risk in children. While researchers have documented a decline in antidepressant use in children over this time period, less is known about whether specific safety information conveyed in individual warnings was reflected in treatment patterns. (2001)(2002)(2003)(2004)(2005) for a national sample of privately insured children were used to construct treatment episodes (N=23,529). For each new episode of major depressive disorder, it was determined whether children's treatment followed specific recommendations included in warnings released by the FDA. Treatment recommendations pertained to the use of the antidepressants paroxetine and fluoxetine and to patient monitoring. Treatment patterns were expected to change as the nature of risk information conveyed by the FDA changed over time. Methods-Thomson Marketscan claims dataResults-The timing of FDA recommendations was associated with trends in the use of paroxetine and fluoxetine by children with major depressive disorder newly initiating antidepressant treatment. However, no evidence of increases in outpatient visits (i.e., monitoring) among depressed children initiating antidepressants was found.Conclusions-Release of specific risk and benefit information by the FDA was associated with changes in prescribing, but not outpatient follow-up. These results suggest the FDA plays an important role in communicating information to the public and providers, but while public health safety warnings were associated with changes in some practice patterns, not all recommendations conveyed in warnings were followed.

A decline in depression treatment following FDA antidepressant warnings largely explains racial/ethnic disparities in prescription fills

“…After the warning, significant declines were observed in pediatric antidepressant use (Olfson, Marcus et al 2008, Busch, Frank et al 2010). These declines were driven predominantly by declines in antidepressant prescribing for white youth and not racial/ethnic minority youth (DePetris and Cook 2013), suggesting that the BW did not influence antidepressant prescribing for minority youth and white youth equally.…”

Speaking the same language? International variations in the safety information accompanying top-selling prescription drugs

“…The drug prescribing information is a key source of drug safety facts for prescribers or pharmacists,2 3 who are expected to discuss these details with patients to educate them about expected benefits and risks of therapy 4 – 8. However, several observers have noted over many years that the prescribing information as currently written and disseminated is unlikely to serve this goal effectively 9 – 13.…”

The FDA and ABCs

“…One study suggests there was a slight increase in receipt of any psychotherapy – among treated adolescents, the percent receiving at least one psychotherapy visit rose less than 5 percent in the period after the warnings (Valluri et al 2010). In contrast, other studies found no such increase (Busch et al 2010; Libby et al 2007). In addition, the types of providers prescribing antidepressants shifted, with primary care physicians writing a smaller share of total antidepressant prescriptions compared with psychiatrists after the FDA warnings (Nemeroff et al 2007; Olfson, Marcus and Druss 2008).…”

“…In recent years, multiple studies have documented large declines in pediatric antidepressant use coincident with the 2004 FDA advisories and warnings, with most estimates suggesting that antidepressant use fell by 20 percent to 30 percent relative to the peak levels of antidepressant use in the 12 to 24 months surrounding the warnings (Busch et al 2010; Busch et al 2011; Gibbons et al 2007; Kurian et al 2007; Libby et al 2007; Nemeroff et al 2007; Olfson, Marcus and Druss 2008; Valluri et al 2010). The most-often cited of these studies are summarized briefly in Appendix Table I.…”

“…The evidence to date, described below in detail, demonstrates that the FDA's release of this new safety information was widely covered in the popular press (Barry and Busch, 2010), and accompanied abrupt declines in pediatric and adolescent antidepressant use of 20-30 percent following years of steady increases in pediatric and adolescent antidepressant use (Busch et al 2010; Gibbons et al 2007; Libby et al 2007; Nemeroff et al 2007; Olfson, Marcus, and Druss 2008; Rosack, 2005). During the period immediately before and after the FDA warnings on antidepressants, the extensive margin of treatment (seeking any treatment versus none) did not change measurably, as we describe below.…”