ST LOUIS (MD Consult) - On July 14, 2009, the US Food and Drug Administration (FDA) announced that it is requiring 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. The labels referenced in the announcement pertain to the following medications:

 

sirolimus (marketed as Rapamune);

cyclosporine (marketed as Sandimmune and generics);

cyclosporine modified (marketed as Neoral and generics);

mycophenolate mofetil (marketed as Cellcept and generics); and

mycophenolic acid (marketed as Myfortic).

 

These immunosuppressant drugs are used as antirejection therapy for persons with certain organ transplants. The association of BK virus–associated nephropathy has previously been reported for another immunosuppressant drug, tacrolimus (marketed as Prograf). Monitoring for this serious risk and providing early intervention are critical to patient safety. The FDA advises that consideration be given to adjustments in immunosuppression therapy for patients who experience BK virus–associated nephropathy.

The FDA conducted an analyses of data from its Adverse Event Reporting System to characterize the association between BK virus–associated nephropathy and the use of the referenced immunosuppressant drugs. The occurrence of BK virus–associated nephropathy has primarily been observed in patients with kidney transplants.

 

The FDA is continuing to review the safety of immunosuppressant drug products used in renal transplantation. The agency urges both health care professionals and patients to report adverse effects from the use of immunosuppressant drug products 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.

圣路易斯(MD Consult)—2009年7月14日，美国食品药品监督管理局(FDA)发表声明要求免疫抑制剂制造商更新其药物标签，以注明免疫受抑制的患者发生机会感染的风险提高，如潜伏性病毒感染的激活，包括BK病毒相关性肾病。声明中提到的药物有：

 

西罗莫司(商品名:Rapamune，雷帕鸣)

环孢菌素(商品名: Sandimmune，山地明)

新剂型(微乳化)环孢菌素(商品名:Neoral，新山地明)

麦考酚酸酯(商品名: Cellcept，骁悉)

麦考酚酸(商品名:Myfortic，米芙)

 

这些免疫抑制剂用于接受器官移植患者的抗排斥治疗。之前有学者报告，BK病毒相关性肾病与另外一种免疫抑制剂——他克莫司(商品名:Prograt，普乐可复)相关。监测这种严重风险并进行早期干预对于患者的安全至关重要。FDA建议，对于发生BK病毒相关性肾病的患者，应考虑调整其免疫抑制治疗的方案。

 

FDA通过分析来自其不良反应报告系统的数据发现了BK病例相关性肾病与应用上述免疫抑制剂之间的关系。BK病毒相关性肾病最初是在肾移植患者中发现。

 

FDA一直在审查免疫抑制剂在肾移植患者中的安全性。FDA敦促医疗人员和患者通过以下3种方式向其报告应用免疫抑制剂的不良反应：FDA MedWatch不良反应在线报告系统、电话(1-800-FDA-1088)、用已付费邮件将填写好的FDA3500档案表寄至MedWatch, 5600 Fishers Lane, Rockville, Md 20852-9787，或发传真至1-800-FDA-0178。