FDA要求部分器官移植排异药物修改标签

网络转载　|　网络转载　2009年7月22日　浏览:509

　　近日，美国食品药品管理局（FDA）表示，其将要求诺华、罗氏及其他生产防治器官移植排异药物的制药公司在其药物标签中注明，使用该药时，患者有患机遇性感染的风险。肾友网——肾移植之友x[4AKz ].K:oz

Q"w2dgj6G$f |'x0　　周二，FDA在其网站上公布的一份声明中称，被要求修改标签的药物包括惠氏的Rapamune、诺华的Neoral与Myfortic，以及罗氏的Cellcept与Sandimmune。肾友网——肾移植之友8`7z'I3p,H |E ~
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B J^ @ ~5_\:{s0　　FDA表示，根据FDA不良事件报告系统的分析，使用这些药物的器官移植患者患BK病毒相关性肾病之类感染性疾病的风险增加。其指出：“BK病毒相关性肾病可能会演变为肾移植丢失。由医护人员对这一严重风险进行监控并进行早期预防是至关重要的”。
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　　FDA还表示，其一直在对肾移植患者使用的免疫抑制剂药物的安全性进行审查。
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[英语新闻]肾友网——肾移植之友5}S'B EXf3mE,~6X W
Kidney Transplant Drugs Receive New Warnings About Infection Side Effects肾友网——肾移植之友?iL'b)?BT"R
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F#Xy*Px B0July 15th, 2009 • Filed Under: News • No Comments肾友网——肾移植之友4L
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The FDA is requiring new warnings on several immunosuppressant drugs designed to prevent renal transplant patients from rejecting new kidneys. The new labeling will warn users of potential side effects that may increase the risk of infections due to a suppressed immune system.肾友网——肾移植之友;lC ~vVU`m
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According to an FDA alert issued Tuesday, the immunosuppressant drugs affected by the new warnings include Rapamune (sirolimus), Sandimmune (cyclosporine) and its generics, Neoral (cyclosporine modified) and its generics, CellCept (mycophenolate mofetil) and its generics, and Myfortic (mycophenolic acid). A similar warning is already in place on the label for the immunosuppressant drug Prograf (tacrolimus).
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~:Q%J{U0Immunosuppressant drugs are prescribed to transplant patients to prevent the body’s immune system from attacking new organs, which are often recognized by the body as foreign invaders. However, the FDA indicates that depressing the immune system leaves patients at risk for opportunistic infections, which could cause serious injury or death to the patient.
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The FDA announcement says kidney transplant patients were especially vulnerable, and indicates that monitoring for this serious risk is critical.肾友网——肾移植之友~QNL[
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Some of the immunosuppressant drugs already contain warnings information about the infection risk, as well as warnings about other serious side effects.肾友网——肾移植之友!q{9t0_;L(w^S

y~j0y7d,R0In July 2008, new warnings were added about potential CellCept and Myfortic side effects which could increase the risk of progressive multifocal leukoencephalopathy (PML), a rare and often fatal brain infection that attacks the white matter areas of the brain. In addition, a “black box” warning, which is the most stringent warning possible under federal regulations, was added to the drugs in November 2007 indicating a potential risk of Myfortic and CellCept birth defects, such as cleft palate, cleft lip and ear deformities, when taken during pregnancy.
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Last month the FDA issued a warning to transplant doctors that switching patients to Rapamune after a liver transplant may increase the risk of death. The warning came after a recent study by the manufacturer, Wyeth, revealed that the chance of liver rejection was “significantly higher” for stable liver transplant patients who switched to Rapamune after first using a calcineurin inhibitor (CNI)-based immunosuppressive treatment.
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