Netherlands Pharmacovigilance Center Lareb, 's-Hertogenbosch, The Netherlands.
J Thromb Haemost. 2014 Sep;12(9):1385-7. doi: 10.1111/jth.12622. Epub 2014 Aug 13.
The Pharmacovigilance Centre Lareb received 621 reports of possible adverse drugs reactions on Diane-35® . Of all reports, 388 were received after media attention. Of the 309 reports of thromboembolic adverse drugs reactions, 18 cases were fatal. In 31 cases the thromboembolic adverse drugs reaction was initially not recognized as such. The analysis and the turmoil of the 'Diane affair' gave rise to the following reflections: Reflection 1. Continuous awareness and attention of risk of medicines is needed, also for known risks, for timely recognition of adverse drugs reactions. Reflection 2. Reporting side effects should be part of the professional attitude. Reports play a pivotal role in the detection of new adverse drugs reactions and the conditions under which known adverse drugs reactions occur. Reflection 3. Improvement of adequate use of drugs. Pharmacovigilance not only has the aim to improve knowledge on risk of medicines, but also the aim of getting this knowledge into Health Care practice.
荷兰药品不良反应监测中心 Lareb 收到了 621 例关于 Diane-35® 的可疑药物不良反应报告。所有报告中，有 388 例是在媒体关注之后收到的。在 309 例血栓栓塞性药物不良反应报告中，有 18 例是致命的。在 31 例中，最初并未将血栓栓塞性药物不良反应识别为血栓栓塞性药物不良反应。对“Diane 事件”的分析和讨论引发了以下几点思考：
思考 1：需要持续关注和警惕药物风险，即使是已知风险，也要及时识别药物不良反应。
思考 2：报告药物副作用应成为专业态度的一部分。报告在发现新的药物不良反应和已知药物不良反应发生的条件方面发挥着关键作用。
思考 3：改善药物的合理使用。药物警戒不仅旨在提高对药物风险的认识，还旨在将这些知识应用于医疗保健实践中。
