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【drug-news】FDA要求修改部分免疫抑制剂的标签信息

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FDA ALERT [07/14/2009]:

The U.S. Food and Drug Administration (FDA) is requiring the makers of certain immunosuppressant drugs to update their labeling to reflect that immunosuppressed patients are at increased risk for opportunistic infections, such as activation of latent viral infections, including BK virus-associated nephropathy. These immunosuppressant drugs are used to protect against the rejection of certain organ transplants.

Class labeling changes are required for the following immunosuppressant drugs:

sirolimus marketed as Rapamune
cyclosporine marketed as Sandimmune and generics
cyclosporine modified marketed as Neoral and generics
mycophenolate mofetil marketed as Cellcept and generics
mycophenolic acid marketed as Myfortic
The FDA conducted analyses of its Adverse Event Reporting System (AERS) to characterize the association between BK virus-associated nephropathy and the use of these immunosuppressant drugs. The occurrence of BK virus-associated nephropathy is primarily observed in renal transplant patients.

BK virus-associated nephropathy can progress to renal allograft loss. Monitoring for this serious risk and early intervention by the health care provider is critical. Adjustments in immunosuppression therapy should be considered for patients who develop BK virus-associated nephropathy.

The association of BK virus-associated nephropathy has previously been reported for another immunosuppressant drug, tacrolimus (marketed as Prograf). Information about the increased risk for opportunistic infections, including activation of latent viral infections, is included in the prescribing information for Prograf. Currently the prescribing information for the other immunosuppressant drugs does not adequately warn about this possible serious adverse event. Based on this new safety information, FDA is requiring, under the authorities granted under the Food and Drug Administration Amendments Act (FDAAA) of 2007, that manufacturers of these immunosuppressants update their prescribing information to include stronger warnings about the risk of BK virus-associated nephropathy

This information reflects FDA’s current analysis of data available to FDA concerning these products. FDA intends to update this document when additional information or analyses become available.

FDA is continuing to review the safety of immunosuppressant drug products used in renal transplantation. The FDA urges both healthcare professionals and patients to report side effects from the use of immunosuppressant drug products to the FDA's MedWatch Adverse Event Reporting program using the contact information at the bottom of this sheet.

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm171654.htm

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2009-07-15 16:25 浏览 : 1040 回复 : 2

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FDA ALERT [07/14/2009]:

The U.S. Food and Drug Administration (FDA) is requiring the makers of certain immunosuppressant drugs to update their labeling to reflect that immunosuppressed patients are at increased risk for opportunistic infections, such as activation of latent viral infections, including BK virus-associated nephropathy. These immunosuppressant drugs are used to protect against the rejection of certain organ transplants.
美国食品药品监督管理局（FDA）正要求部分免疫抑制药物的生产商们更新其药品标签，以反映接受免疫抑制治疗的患者会增加发生条件感染的风险，如潜在的病毒感染被激活（包括与BK病毒肾病）。这些免疫抑制药物是用于预防某些器官移植的排斥反应。

Class labeling changes are required for the following immunosuppressant drugs:
sirolimus marketed as Rapamune
cyclosporine marketed as Sandimmune and generics
cyclosporine modified marketed as Neoral and generics
mycophenolate mofetil marketed as Cellcept and generics
mycophenolic acid marketed as Myfortic
以下免疫抑制药物被要求进行标签修改：
西罗莫司（sirolimus），商品名雷帕鸣（Rapamune）
环孢素（cyclosporine），商品名山地明（Sandimmune）及其仿制药
环孢素（cyclosporine），商品名新山地明（Neoral）及其仿制药
霉酚酸酯（mycophenolate mofetil），商品名Cellcept及其仿制药
霉酚酸（mycophenolic acid），商品名Myfortic

The FDA conducted analyses of its Adverse Event Reporting System (AERS) to characterize the association between BK virus-associated nephropathy and the use of these immunosuppressant drugs. The occurrence of BK virus-associated nephropathy is primarily observed in renal transplant patients.
FDA对其不良事件报告系统（AERS）（所收集到的数据）进行了分析，以描述在BK病毒肾病与使用这些免疫抑制药物之间的关联性。BK病毒肾病的发生最初见于肾移植患者中。

BK virus-associated nephropathy can progress to renal allograft loss. Monitoring for this serious risk and early intervention by the health care provider is critical. Adjustments in immunosuppression therapy should be considered for patients who develop BK virus-associated nephropathy.
BK病毒肾病可导致肾移植失败。通过医疗卫生专业人士对该风险的监测和早期干预是关键。对于发生BK病毒肾病的患者，应考虑调整免疫抑制治疗。

The association of BK virus-associated nephropathy has previously been reported for another immunosuppressant drug, tacrolimus (marketed as Prograf). Information about the increased risk for opportunistic infections, including activation of latent viral infections, is included in the prescribing information for Prograf. Currently the prescribing information for the other immunosuppressant drugs does not adequately warn about this possible serious adverse event. Based on this new safety information, FDA is requiring, under the authorities granted under the Food and Drug Administration Amendments Act (FDAAA) of 2007, that manufacturers of these immunosuppressants update their prescribing information to include stronger warnings about the risk of BK virus-associated nephropathy
与BK病毒肾病的联系最初报道于另一种免疫抑制药物他克莫司（商品名Prograf）。在Prograf的处方信息中已包含了有关增加条件感染风险（包括潜在性病毒感染被激活）的内容。其他免疫抑制药物的处方信息尚未对这一可能发生的严重不良事件进行充分地提醒。根据这一新的安全性信息，在2007年颁布的《食品和药品管理法修正案》的授权下，FDA正在督促这些免疫抑制剂的生产商们更新其处方信息，以包含有关BK病毒肾病风险的更明显的警告。

This information reflects FDA’s current analysis of data available to FDA concerning these products. FDA intends to update this document when additional information or analyses become available.
以上信息反映了FDA对可获得的涉及这些药品的数据的最新分析。一旦有其他信息或分析时，FDA会主动更新该文件。

FDA is continuing to review the safety of immunosuppressant drug products used in renal transplantation. The FDA urges both healthcare professionals and patients to report side effects from the use of immunosuppressant drug products to the FDA's MedWatch Adverse Event Reporting program using the contact information at the bottom of this sheet.
FDA将继续对免疫抑制药物在肾移植患者中使用的安全性进行审核。FDA鼓励医疗卫生专业人士和患者向FDA的MedWatch不良事件报告系统报告与使用免疫抑制药相关的副作用

2009-07-15 16:26

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FDA要求修改部分免疫抑制剂的标签信息

7月14日，美国食品药品监督管理局（FDA）正要求部分免疫抑制药物的生产商们更新其药品标签，以反映接受免疫抑制治疗的患者会增加发生条件感染的风险，如潜在的病毒感染被激活（包括BK病毒肾病）。这些免疫抑制药物是用于预防某些器官移植的排斥反应。

以下免疫抑制药物被要求进行标签修改：
西罗莫司（sirolimus），商品名雷帕鸣（Rapamune）
环孢素（cyclosporine），商品名山地明（Sandimmune）及其仿制药
环孢素（cyclosporine），商品名新山地明（Neoral）及其仿制药
霉酚酸酯（mycophenolate mofetil），商品名Cellcept及其仿制药
霉酚酸（mycophenolic acid），商品名Myfortic

FDA对其不良事件报告系统（AERS）（所收集到的数据）进行了分析，以描述在BK病毒肾病与使用这些免疫抑制药物之间的关联性。BK病毒肾病的发生最初见于肾移植患者中。

BK病毒肾病可导致肾移植失败。通过医疗卫生专业人士对该风险的监测和早期干预是关键。对于发生BK病毒肾病的患者，应考虑调整免疫抑制治疗。

与BK病毒肾病的联系最初报道于另一种免疫抑制药物他克莫司（商品名Prograf）。在Prograf的处方信息中已包含了有关增加条件感染风险（包括潜在性病毒感染被激活）的内容。其他免疫抑制药物的处方信息尚未对这一可能发生的严重不良事件进行充分地提醒。根据这一新的安全性信息，在2007年颁布的《食品和药品管理法修正案》的授权下，FDA正在督促这些免疫抑制剂的生产商们更新其处方信息，以包含有关BK病毒肾病风险的更明显的警告。

以上信息反映了FDA对可获得的涉及这些药品的数据的最新分析。一旦有其他信息或分析时，FDA会主动更新该文件。

FDA将继续对免疫抑制药物在肾移植患者中使用的安全性进行审核。FDA鼓励医疗卫生专业人士和患者向FDA的MedWatch不良事件报告系统报告与使用免疫抑制药相关的副作用。

原文链接：http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm171654.htm

背景知识：
BK病毒（BK virus，BKV）是1971年从一例肾移植术后免疫功能受到抑制的病人尿液中分离到的。以病人的名字命名，归属于DNA病毒。全世界大约75%以上的人群（成人几乎100%）含该病毒的抗体。肾脏是健康人BKV潜伏感染的主要部位。免疫抑制如肾移植或妊娠期间可引起病毒激活。

2009-07-15 16:27

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