Spillover Effects on Treatment of Adult Depression in Primary Care After FDA Advisory on Risk of Pediatric Suicidality With SSRIs

Valuck, Robert J.; Libby, Anne M.; Orton, Heather D.; Morrato, Elaine H.; Allen, Richard R.; Baldessarini, Ross J.

doi:10.1176/appi.ajp.2007.07010007

Cited by 97 publications

(66 citation statements)

References 21 publications

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“…These findings are similar to those of other studies that documented decreases in treatment episodes for depression in children and adolescents and young adults in association with regulatory warnings in the United States. 8,9 It is of concern that, in an environment where the treatment of a life-threatening disorder has become more complicated, vulnerable patients are receiving less care. Richardson and colleagues 18 reported that attitudes of health care providers toward the treatment of depression in adolescents have not changed, which suggests that the changes in the treatment of depression observed in the United States may have been related to patient and family variables.…”

Section: Discussionmentioning

confidence: 99%

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Effect of regulatory warnings on antidepressant prescription rates, use of health services and outcomes among children, adolescents and young adults

Katz¹,

Kozyrskyj²,

Prior³

et al. 2008

Canadian Medical Association Journal

152

112

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the Committee on Safety of Medicines in the United Kingdom issued a warning against the use of paroxetine in children and adolescents. Health Canada and the US Food and Drug Administration issued further warnings, on June 3 and Oct. 15, 2004, respectively, about the use of all newer antidepressants (selective serotonin reuptake inhibitors and selective norepinephrine reuptake inhibitors) in children and adolescents. Similar warnings have been issued by many other regulatory agencies worldwide.1 These warnings were issued on the basis of results from randomized controlled trials showing that children and adolescents taking antidepressants were at greater risk of suicidal behaviour than those taking placebos. 2There are few data on the relation between regulatory action and outcomes, both in general and specifically for the warnings about antidepressant use in children and adolescents. Preliminary findings from the United Kingdom 3 and the United States 4-7 suggest that antidepressant prescribing decreased following the warnings in those jurisdictions. This has raised concerns about the relation between this regulatory action and the treatment of depression. 5,8,9 In a study of the effect of regulatory action on benzodiazepine prescribing and hip fracture rates, Wagner and colleagues 10 found no significant change in fracture rates after the regulatory action.

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Section: Discussionmentioning

confidence: 99%

“…This has raised concerns about the relation between this regulatory action and the treatment of depression. 5,8,9 In a study of the effect of regulatory action on benzodiazepine prescribing and hip fracture rates, Wagner and colleagues 10 found no significant change in fracture rates after the regulatory action. …”

mentioning

confidence: 99%

Effect of regulatory warnings on antidepressant prescription rates, use of health services and outcomes among children, adolescents and young adults

Katz¹,

Kozyrskyj²,

Prior³

et al. 2008

Canadian Medical Association Journal

152

112

View full text Add to dashboard Cite

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“…These first two analyses were not published in the peer-reviewed literature, but rather were conducted by news organizations and published in the lay press. Gibbons et al Considering the October 2003 FDA advisory as the policy action of interest, this study concluded there was a 58 percent drop in use of SSRIs in children diagnosed with depression from the level to be expected if prescribing trends begun prior to this controversy had continued; the drop for adults was smaller (33 percent) (3,10). They found no increase in use of psychotherapy or provider contact in the first three months of treatment (11).…”

Section: Evidence On Consequences Of Fda Actionsmentioning

confidence: 91%

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

Busch

Frank

Leslie³

et al. 2010

Psychiatric Services

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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.

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“…After the initial 2004 BBW release, depression diagnosis and antidepressant prescriptions were reduced across all age groups. [56][57][58] Further research has clarified some of the questions raised by the BBW. In a move that was less publicized than the initial BBW, the FDA modified the BBW in 2009 on the basis of further analyses.…”

Section: Antidepressant Bbwmentioning

confidence: 99%

Practical Suicide-Risk Management for the Busy Primary Care Physician

McDowell

Lineberry

Bostwick

2011

Mayo Clinic Proceedings

109

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Suicide is a public health problem and a leading cause of death. The number of people thinking seriously about suicide, making plans, and attempting suicide is surprisingly high. In total, primary care clinicians write more prescriptions for antidepressants than mental health clinicians and see patients more often in the month before their death by suicide. Treatment of depression by primary care physicians is improving, but opportunities remain in addressing suicide-related treatment variables. Collaborative care models for treating depression have the potential both to improve depression outcomes and decrease suicide risk. Alcohol use disorders and anxiety symptoms are important comorbid conditions to identify and treat. Management of suicide risk includes understanding the difference between risk factors and warning signs, developing a suicide risk assessment, and practically managing suicidal crises. Mayo Clin © 2011 Mayo Foundation for Medical Education and ResearchOn completion of this article, you should be able to (1) [3][4][5] These worries are based on population-level effects of the persistent increased unemployment rate due to the severe recession. [3][4][5] Serious thoughts of suicide, plans for suicide, and suicide attempts are surprisingly common in the general population (Table 1). 6 Despite that frequency, death by suicide is still a low base-rate occurrence and impossible to predict accurately. 7,8 Although a relatively uncommon event, suicide has a lifelong and profound effect personally on the families, friends, and physicians of the person committing suicide.In this concise review, we provide a pragmatic and clinically relevant background on suicide risk management for nonpsychiatrists. We will use frequently asked questions based on our clinical experiences and review key principles of depression treatment as they relate to suicide risk management. We will update and synthesize information gained from research into concerns associated with the antidepressant black box warnings (BBWs) for suicidality and highlight their 2009 revisions. 9 We will then close by describing basic principles in identifying those at risk of suicide, assessing them, and devising practical patient management strategies. IMporTAnCE To prIMAry CArETwo practice realities have spurred interventions to improve primary care recognition and treatment of depression as a public health suicide prevention strategy. 10,11 First, patients dying by suicide visit primary care physicians more than twice as often as mental health clinicians. 10 A review of studies analyzing this clinical scenario estimated 45% of those dying by suicide saw their primary care physician in the month before their death. 10 Only 20% saw a mental health professional 10 in the preceding month. Women and older patients are more likely to have sought care in the month before suicide 10 than men and younger patients. Second, generalists (internists, pediatricians, family physicians) write most antidepressant prescriptions (62%) in the United States. 11 When...

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Spillover Effects on Treatment of Adult Depression in Primary Care After FDA Advisory on Risk of Pediatric Suicidality With SSRIs

Abstract: The FDA advisory had a significant spillover effect into community treatment for adults with depression, despite the focus of the policy on pediatric patients.

Cited by 97 publications

References 21 publications

Effect of regulatory warnings on antidepressant prescription rates, use of health services and outcomes among children, adolescents and young adults

Effect of regulatory warnings on antidepressant prescription rates, use of health services and outcomes among children, adolescents and young adults

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

Practical Suicide-Risk Management for the Busy Primary Care Physician

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