Abstract:
BACKGROUND:Hydroxyzine is indicated for the management of anxiety, skin and sleep disorders. In 2015, the European Medicines Agency (EMA) concluded that hydroxyzine was pro-arrhythmogenic and changes to the product information were implemented in Europe. This study aimed to evaluate their impact in Denmark, Scotland, England and the Netherlands. METHOD:Quarterly time series analyses measuring hydroxyzine initiation, discontinuation, and switching to other antihistamines, benzodiazepines and antidepressants in Denmark, England, Scotland and the Netherlands from 2009 to 2018. Data were analysed using interrupted time series regression. RESULTS:Hydroxyzine initiation in quarter one 2010 in Denmark, Scotland, England and the Netherlands per 100 000 was: 23.5, 91.5, 35.9 and 34.4 respectively. Regulatory action was associated with a significant: immediate fall in hydroxyzine initiation per 100 000 in England (-12.05, 95%CI -18.47 to -5.63) and Scotland (-19.01, 95%CI -26.99 to -11.02); change to a negative trend in hydroxyzine initiation per 100 000/quarter in England (-1.72, 95%CI -2.69 to -0.75) and Scotland (-2.38, 95%CI -3.32 to -1.44). Regulatory action was associated with a significant: immediate rise in hydroxyzine discontinuation per 100 000 in England (3850, 95%CI 440-7240). No consistent changes were observed in the Netherlands or Denmark. Regulatory action was associated with no switching to other antihistamines, benzodiazepines or antidepressants following hydroxyzine discontinuation in any country. CONCLUSION:The 2015 EMA regulatory action was associated with heterogeneous impact with reductions in hydroxyzine initiation varying by country. There was limited impact on discontinuation with no strong evidence suggesting unintended consequences of major switching to other antihistamines, benzodiazepines or antidepressants.
journal_name
Pharmacoepidemiol Drug Safjournal_title
Pharmacoepidemiology and drug safetyauthors
Morales DR,Macfarlane T,MacDonald TM,Hallas J,Ernst MT,Herings RMC,Smits E,Overbeek JA,Mitchell L,Morant S,Mackenzie I,Doney ASF,Robertson C,Bennie M,Wei L,Nicholson L,Morris C,Flynn RWFdoi
10.1002/pds.5191subject
Has Abstractpub_date
2021-01-01 00:00:00eissn
1053-8569issn
1099-1557pub_type
杂志文章abstract:PURPOSE:To evaluate the concurrent validity of three European sets of drug-specific indicators of prescribing quality METHODS:In 200 hip fracture patients (≥65 years), consecutively recruited to a randomized controlled study in Sahlgrenska University Hospital in 2009, quality of drug treatment at study entry was asses...
journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章,随机对照试验
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更新日期:2015-09-01 00:00:00
abstract:PURPOSE:To develop a method for data-driven exploration in pharmacovigilance and illustrate its use by identifying the key features of individual case safety reports related to medication errors. METHODS:We propose vigiPoint, a method that contrasts the relative frequency of covariate values in a data subset of intere...
journal_title:Pharmacoepidemiology and drug safety
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pub_type: 杂志文章
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更新日期:2008-07-01 00:00:00
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更新日期:2009-08-01 00:00:00
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更新日期:2016-09-01 00:00:00
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更新日期:2015-01-01 00:00:00
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更新日期:2004-01-01 00:00:00
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更新日期:2004-07-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
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更新日期:2011-11-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
pub_type: 杂志文章
doi:10.1002/pds.1386
更新日期:2007-07-01 00:00:00
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journal_title:Pharmacoepidemiology and drug safety
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