Generic drug company prosecuted for incomplete description of risks in a patient information leaflet

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Generic drug company prosecuted for incomplete description of risks in a patient information leaflet

机译：普通药物公司被起诉患者信息传单中的风险的不完整描述

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In France, in late 2019, a court ruled that Biogaran was responsible for a fatality linked to the pulmonary toxicity of amiodarone, because the patient information leaflet at the time (in 2009) did not specify a risk of death. The patient receiving amiodarone had consulted a doctor because of severe hypoxia. He had diffuse interstitial pneumonitis which progressed to pulmonary fibrosis and death (2).In its defence, Biogaran argued that a patient information leaflet had to be "intelligible and understandable", that the symptoms cited were "likely to alert the patient", and that the risks were mentioned in the summary of product characteristics (SPC) (2).

机译：2019年末，法国一家法院裁定，Biogaran应对与胺碘酮肺毒性相关的死亡负责，因为当时（2009年）的患者信息传单没有明确说明死亡风险。接受胺碘酮治疗的患者因严重缺氧而就医。他患有弥漫性间质性肺炎，并进展为肺纤维化和死亡（2）。在辩护中，Biogoran辩称，患者信息传单必须“易懂且可理解”，所引用的症状“可能会提醒患者”，并且产品特征总结（SPC）（2）中提到了风险。

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《Prescrire international》 |2021年第224期|共1页
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正文语种 eng
中图分类药学;
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Generic drug company prosecuted for incomplete description of risks in a patient information leaflet

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