Did intense adverse media publicity impact on prescribing of paroxetine and the notification of suspected adverse drug reactions? Analysis of routine databases, 2001-2004

Did intense adverse media publicity impact on prescribing of paroxetine and the notification of suspected adverse drug reactions? Analysis of routine databases, 2001-2004
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DOI:
10.1111/j.1365-2125.2005.02527.x
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发表时间:
2006-02-01
影响因子:
3.4
通讯作者:
Gunnell, D
Gunnell, D
中科院分区:
医学3区
文献类型:
--
作者:
Martin, RM;May, M;Gunnell, D

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目的记录媒体对帕罗西汀可能不良反应的关注对英国临床实践的影响。设计分析2001- 2004年国家选择性5-羟色胺再吸收抑制剂(SSRI)处方趋势和黄牌药物不良反应报告。结果从2001年的稳定状态开始,帕罗西汀处方量从2002年4月起急剧下降,与美国的监管行动相一致;帕罗西汀处方量随后每月下降1.87%(95%置信区间-2.06,-1.68)。其他SSRI处方每月增加1%,直到2003年12月英国对儿童SSRI进行了一次重要审查,此后处方趋于稳定。媒体宣传与短期高峰黄牌报告相关paroxetine.Conclusion福尔斯在帕罗西汀和其他SSRI处方在英国相吻合,分别与监管通信从美国和英国,但协会可能有非因果关系或其他解释。帕罗西汀不良反应的报告似乎增加后,不利的媒体宣传药物。
Aim To document the impact on clinical practice in England of media attention around possible adverse effects of paroxetine.Design Analysis of national selective serotonin reuptake inhibitor (SSRI) prescribing trends and yellow-card adverse drug reaction reports, 2001-2004.Results From a steady state in 2001, paroxetine prescribing declined sharply from April 2002, coinciding with a USA regulatory action; the subsequent decline in paroxetine prescribing was 1.87% per month (95% confidence interval -2.06, -1.68). Other SSRI prescribing increased by 1% per month until a major UK review of SSRIs in children in December 2003, after which prescribing plateaued. Media publicity was associated with short-term peaks in yellow-card reports related to paroxetine.Conclusion Falls in paroxetine and other SSRI prescribing in the UK coincided, respectively, with regulatory communications from the USA and the UK, but associations may have noncausal or other explanations. Reports of adverse reactions to paroxetine appeared to increase after adverse media publicity about the drug.