Disparities in Discontinuing Rosiglitazone Following the 2007 FDA Safety Alert

Qato, Danya M; Trivedi, Amal N.; Mor, Vincent; Dore, David D.

doi:10.1097/mlr.0000000000000502

Cited by 8 publications

(9 citation statements)

References 25 publications

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“…All of the 70 publications included are observational studies based on routinely collected health data, which included health insurance or hospital records. Thus, no RCTs were found for the defined search period.…”

Section: Resultsmentioning

confidence: 99%

“…Unintended effects of a safety warning were examined in six out of 72 studies . These six studies could not be analysed regarding the effectiveness of safety warnings, because an unintended effect occurred in connection with a safety warning, but not as a direct consequence of the content.…”

Section: Resultsmentioning

confidence: 99%

“…In contrast, just 45% (17/38) of the studies in the “others” group were presented as ineffective or partially effective. But 53% (20/38) described an effective impact, and only 2% examined an unintended effect. Details of this group are shown in Data S2.…”

Section: Resultsmentioning

confidence: 99%

“…The contents of the safety warnings were divided into six catego- Unintended effects of a safety warning were examined in six out of 72 studies. 9,28,60,72,75,80 These six studies could not be analysed regarding the effectiveness of safety warnings, because an unintended effect occurred in connection with a safety warning, but not as a direct consequence of the content. One example of this was the increased rate of hospitalisations due to depression after the recommended dosage limit (content of the safety warning) of citalopram in adults was implemented.…”

Section: Contents Of Interventionmentioning

confidence: 99%

“…An adjustment for confounding factors (item 25) was specified in 14% (10) of the included studies. In 9% (3/34)35,37,80 of the studies of the "psychotropic drugs" group and 18%(7/38) 47,64,67,71,73,75,77 of the "others" group, there was an adequate adjustment for confounding in the analyses from which the main findings were drawn. The influence of the media on the implementation…”

mentioning

confidence: 99%

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Do drug‐related safety warnings have the expected impact on drug therapy? A systematic review

Georgi

Lämmel

Datzmann

et al. 2020

Pharmacoepidemiology and Drug

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Purpose The need for drug‐related safety warnings is undisputed, and their impact should also be evaluated. This systematic review investigates and assesses the impact of safety warnings on drug therapy. Methods Studies published in English between January 1998 and December 2018 were searched in EMBASE and MEDLINE, complemented by manual search. Randomised controlled trials, cohort studies with a before/after component, and case‐control studies were included, selected to predefined criteria, and assessed for their reporting and methodological quality. Results Out of 7454 references identified, 72 studies were included. A total of 28/72 (39%) studies described the impact of safety warnings on drug therapy as being effective, whereas 12/72 (17%) studies did not. Further, 26/72 (36%) studies described a partial implementation of the warnings (one part of the warning had an impact on drug therapy and another did not). Unintended effects were investigated in 6/72 (8%) studies. While 34 (47%) studies examined safety warnings on psychotropic drugs using an interrupted time series (ITS) design (53%), a before/after (26%), and a time series design (21%), 38 (53%) studied other substances using an ITS design (34%), a before/after (40%), and a time series design (26%). The proportion of an effective impact on drug therapy was lower in the “psychotropic drugs” group (23%) than in the “others” group (53%). Conclusion Drug‐related safety warnings induce intended and unintended effects. The included studies are of broadly varying methodological quality. To better compare their effectiveness, studies should be conducted using standardised procedures.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%