Safety Notices
September 28, 2009
ST LOUIS (MD Consult) - On September 25, 2009, the US Food and Drug Administration issued an early communication concerning an ongoing review of safety issues with Exjade (deferasirox). Information derived from this review suggests that persons with myelodysplastic syndrome (MDS) who take Exjade may be at higher risk for adverse events such as kidney failure, gastrointestinal hemorrhage (potentially fatal bleeding), and death than persons without MDS who take Exjade.
In conducting their safety review of Exjade, the FDA has found several factors that make it difficult for the agency to draw conclusions without further analysis. These factors include advanced patient age, seriousness of disease, comorbidities, and need for blood transfusions in affected patients. At this time, the FDA has not concluded a causal relationship exists between Exjade and the emerging safety issue.
Many of the patients under review who experienced these serious adverse events were older than 60 years. To add to the confusion, the described events can sometimes occur in persons with MDS who are not taking Exjade. According to the FDA, death and serious adverse events seem to occur less commonly in younger patients with other chronic anemias, such as β-thalassemia and sickle cell disease.
Exjade has several known adverse drug effects, and some patients taking Exjade have died. Already-established adverse events associated with Exjade include kidney and liver failure—particularly in patients who have other conditions that would make them more susceptible to kidney or liver problems—and gastrointestinal ulcers and/or hemorrhage.
Exjade is an oral iron chelator. It was approved in 2005 for patients aged 2 years and older with chronic anemia who have iron overload that occurred as a result of receiving blood transfusions as part of their therapy.
The FDA is working with Novartis, the company that manufactures Exjade, regarding potential revisions to the prescribing information to warn health care professionals about the possible risks of using Exjade in certain patients, and to ensure that the benefits of Exjade outweigh the potential risks, particularly in older patients and patients with MDS.
The FDA is urging both health care professionals and patients to report adverse effects from the use of Exjade to its MedWatch Adverse Event Reporting program online, by telephone (1-800-FDA-1088), or by sending the postage-paid FDA form 3500 by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787, or by fax to 1-800-FDA-0178.
安全须知
2009年9月28日
圣路易斯（MD Consult）——美国食品药品管理局（FDA）于2009年9月25日发布了一项关于正在进行的Exjade（deferasirox）安全问题审查的早期沟通信息。与无骨髓增生异常综合征（MDS）的Exjade使用者相比，罹患MDS的Exjade使用者发生肾衰、胃肠道出血（可能是致命性出血）或死亡等不良事件的风险可能增加。
在对Exjade的安全性进行审查的过程中，美国FDA已经发现存在多种因素使该机构难以在未进行深入分析之前得出结论。这些因素包括晚期患者的年龄、疾病的严重程度、有无合并症、受累患者有无输血的需要。因此，FDA到目前为止并未推断Exjade与新的安全问题之间存在因果关系。
多数在审查中发生严重不良反应事件患者的年龄都在60岁以上。更加令人困惑不解的是，上述不良事件可发生于未服用Exjade的MDS患者。根据FDA的沟通信息，死亡及严重不良事件似乎较少发生于患有β地中海贫血和镰刀型细胞贫血等其他慢性贫血的60岁以下患者。
Exjade存在几种已知的药物不良反应，一些患者在服药后死亡。已知的Exjade相关性不良反应包括肾脏和肝脏衰竭，尤其是存在易导致肝肾受损等其他疾病的患者，以及胃肠道溃疡和（或）出血。
Exjade是一种口服铁螯合剂，于2005年获批用于治疗2岁及以上慢性贫血患者在治疗过程中因接受输血而导致的铁过量。
美国FDA正与Exjade生产商诺华公司协商修改该药的处方信息，以警告医护专业人士某些使用Exjade的患者可能发生的风险，并确保Exjade的使用者尤其是老年患者和MDS患者的获益超过潜在风险。
FDA正敦促医护人员和患者将Exjade使用过程中发生的不良反应报告至其MedWatch 不良事件报告系统，具体方法包括：上网在线报告，或致电1-800-FDA-1088，或者将邮资已付的FDA 3500表邮寄至MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787，或发传真至1-800-FDA-0178。
