Charles Perkins Centre and School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
Institute for Musculoskeletal Health, Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
Br J Clin Pharmacol. 2020 Jul;86(7):1416-1429. doi: 10.1111/bcp.14255. Epub 2020 Mar 20.
Drug regulators issue safety advisories to warn clinicians and the public about new evidence of harmful effects of medicines. It is unclear how often these messages are covered by the media. Our aim was to analyse the extent of media coverage of two medicines that were subject to safety advisories from 2007 to 2016 in Australia, Canada, the United Kingdom and the United States.
Two medicines widely used to treat mental health or physical conditions were selected: citalopram and denosumab. Media reports were identified by searching LexisNexis and Factiva. Reports were included if they stated at least one health benefit or harm. A content analysis of the reports was conducted.
In total, 195 media reports on citalopram and 239 on denosumab were included. For citalopram, 43.1% (84/195) of the reports mentioned benefits, 85.6% (167/195) mentioned harms and 9.7% (19/195) mentioned the harm described in the advisories (cardiac arrhythmia). For denosumab, 94.1% (225/239) of the reports mentioned benefits and 39.7% (95/239) mentioned harms. The harms described in the advisories were rarely mentioned: 10.9% (26/239) of the reports mentioned osteonecrosis and ≤5% mentioned any of the other harms (atypical fractures, hypocalcaemia, serious infections and dermatologic reactions).
We found limited media coverage of the harms highlighted in safety advisories. Almost two-thirds of the media stories on denosumab did not include any information about harms, despite the many advisories during this time frame. Citalopram coverage covered harms more often but rarely mentioned cardiac arrhythmias. These findings raise questions about how to better ensure that regulatory risk communications reach the general public.
药品监管机构发布安全警示，以警告临床医生和公众有关药品新的有害影响的证据。目前尚不清楚这些信息有多少次被媒体报道。我们的目的是分析 2007 年至 2016 年期间在澳大利亚、加拿大、英国和美国发布安全警示的两种药物的媒体报道程度。
选择两种广泛用于治疗精神健康或身体状况的药物：西酞普兰和地舒单抗。通过搜索 LexisNexis 和 Factiva 来确定媒体报道。如果报道至少提到一种健康益处或危害，则将其纳入。对报告进行了内容分析。
共纳入西酞普兰 195 份和地舒单抗 239 份媒体报道。关于西酞普兰，43.1%（84/195）的报道提到了益处，85.6%（167/195）提到了危害，9.7%（19/195）提到了警示中描述的危害（心律失常）。关于地舒单抗，94.1%（225/239）的报道提到了益处，39.7%（95/239）提到了危害。警示中描述的危害很少被提及：239 份报告中有 10.9%（26/239）提到了骨坏死，≤5%的报告提到了其他任何危害（非典型骨折、低钙血症、严重感染和皮肤反应）。
我们发现安全警示中强调的危害在媒体报道中受到限制。在这段时间内，尽管发布了许多警示，但地舒单抗的近三分之二的媒体报道没有包含任何危害信息。西酞普兰的报道更频繁地涵盖了危害，但很少提到心律失常。这些发现引发了关于如何更好地确保监管风险沟通到达公众的问题。
