Evidence map›Paper›PMID 20065205›Full record

ArticleArchives of internal medicine2010

Impact of FDA black box advisory on antipsychotic medication use.

E Ray Dorsey, Atonu Rabbani, Sarah A Gallagher, Rena M Conti, G Caleb Alexander

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Archives of internal medicine, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 89 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
89citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

89 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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29 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors.

E Ray DorseyDepartment of Neurology, University of Rochester Medical Center, New York, USA.
Atonu Rabbani
Sarah A Gallagher
Rena M Conti
G Caleb Alexander

Funding

The University of Rochester's Clinical and Translational Science InstituteKL2RR024136 · NCRR · UNIVERSITY OF ROCHESTER · PI PEARSON, THOMAS ARTHUR · 2006 to 2011
$4.3M
Oncology R&D: Expanding the Role of Economics to Aid Public PolicyK07CA138906 · NCI · UNIVERSITY OF CHICAGO · PI CONTI, RENA MARIE · 2009 to 2013
$672k
An RCT To Decrease Out-Of-Pocket Prescription CostsK08HS015699 · AHRQ · UNIVERSITY OF CHICAGO · PI ALEXANDER, G. CALEB · 2006 to 2010
$617k
AHRQ HHS K08 HS015699AHRQ HHS K08 HS15699-01A1NCI NIH HHS K07 CA138906NCRR NIH HHS KL2 RR024136
6 · The paper itself

Abstract

backgroundIn April 2005, the US Food and Drug Administration (FDA) issued an advisory and subsequent black box warning regarding the risks of atypical anti psychotic use among elderly patients with dementia. The impact of these warnings on atypical drug use is unknown.

methodsWe used quasi-experimental, interrupted time-series analyses to examine nationally representative data from IMS Health's National Disease and Therapeutic Index from January 2003 through December 2008. The primary measurement from this audit of office-based physicians was the use of an atypical antipsychotic agent. We quantified the impact of the advisory on atypical antipsychotic use among all individuals and those 65 years or older with dementia.

resultsFrom January 2003 to March 2005, mentions of total atypical antipsychotic drugs increased at an annual rate of 34%, and among patients with dementia, 16%. In the year prior to the FDA advisory, there were approximately 13.6 million atypical drug mentions, including 0.8 million among those with dementia. In the year following the advisory, atypical drug mentions fell 2% overall and 19% among those with dementia. In 2004, 19% (0.8 of 4.1 million) of drug mentions for dementia were for an atypical agent. By 2008, this proportion decreased to 9% (0.4 of 4.3 million). Atypical drug use slowed for both FDA-approved and off-label indications and declined through 2008 for all populations examined.

conclusionThe FDA advisory was associated with decreases in the use of atypical antipsychotics, especially among elderly patients with dementia.

Indexed as

Drug LabelingRisk ManagementAgedAged, 80 and overAntipsychotic AgentsDementiaHumansPractice Patterns, Physicians'Regression AnalysisUnited StatesUnited States Food and Drug AdministrationAntipsychotic Agents

Identifiers

PMID20065205
PMCPMC4598075

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.