【奥译言】美国FDA就造成患者过度辐射暴露的不良事件发出黑盒警告

2019-05-05 09:52  阅读数:498 标签:


美国食品药品监督管理局(FDA)就铷82发生器标签提出黑盒警告,其中该发生器用于正电子发射断层扫描(PET)心脏灌注显像扫描。


4月29日,美国FDA就最近发生的过度辐射不良事件发布了药品安全警报。制造商Bracco Diagnostics和Jubilant DraxImage上个月还致函医护人员。信函中交代了因使用不当的发生器洗脱溶液而导致患者暴露于高浓度辐射的不良事件。通过新的黑盒警告,这类用户错误将能得以解决,并提醒用户使用正确的洗脱溶液。


Bracco Diagnostics公司生产的CardioGen-82和Jubilant DraxImage公司生产的Ruby-Fill这两种系统需要使用不含添加剂的0.9%氯化钠注射液(USP)。


“这类不良事件已经报告给FDA,说明了使用不当的溶液洗脱发生器的问题,包括林格氏乳酸盐液等含钙溶液。溶液中的钙会与发生器结构中的放射性锶82和锶85相互作用。然后,这些锶的放射性同位素“冲进”向患者施用的铷注射液,“FDA表示。


“锶同位素可以在包含骨骼在内的器官中沉积高水平的放射性,从而导致骨髓功能和免疫系统受到抑制”。此外,还会导致其他长期风险出现,比如由辐射诱发的癌症。


美国FDA澄清说,那些需要进行心肌灌注显像扫描(MPI)的患者应继续接受此类扫描,但需要就使用铷82发生器的问题咨询其医护人员。


上述两家制造商都将进行相关测试,以评估锶同位素可能带来的风险。


英文原文


FDA Flags Incidents of Excess Radiation Exposure to Patients


The US Food and Drug Administration (FDA) imposed a boxed warning on the labeling of rubidium 82 generators, which are used with Positron Emission Tomography (PET) heart perfusion imaging scans.


The agency circulated the drug safety alert on Monday in response to recent excess radiation exposure incidents. Manufacturers Bracco Diagnostics and Jubilant DraxImage also sent letters last month to inform health care providers about incidents of patients’ exposure to high levels of radiation due to incorrect solutions to elute the generators. The new boxed warning will address this user error as a reminder to use correct solutions.


Bracco Diagnostics’ CardioGen-82 and Jubilant DraxImage’s Ruby-Fill are the two systems that require additive-free 0.9% sodium chloride injection USP.


“Incidents have been reported to FDA where an incorrect solution was used to elute the generator, including calcium-containing solutions such as lactated ringers. The calcium in the solution interacts with radioactive strontium 82 and strontium 85 in the generator’s structure. These radioisotopes of strontium then ‘break through’ into the rubidium injection administered to patients,” FDA said. “The strontium isotopes can deposit high levels of radioactivity in organs including the bone, which can lead to suppressed bone marrow function and suppression of the immune system. Additional long-term risks could include radiation-induced cancers.”


The agency clarified that patients who need myocardial perfusion imaging scans should continue getting such scans and consult with their health care providers on concerns with using rubidium 82 generators.


Both manufacturers are going to conduct testing to evaluate the risks posed by the strontium isotopes.




来源:RAPS

原文链接:https://www.raps.org/news-and-articles/news-articles/2019/4/fda-flags-incidents-of-excess-radiation-exposure-t

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