FDA News（July 27, 2007 ）
FDA Permits Restricted Use of Zelnorm for Qualifying Patients
The U.S. Food and Drug Administration announced that it is permitting the restricted use of Zelnorm (tegaserod maleate) under a treatment investigational new drug (IND) protocol to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55 who meet specific guidelines.
In some instances, patients with a serious or life-threatening disease or condition who are not enrolled in a clinical trial may be treated with a drug not approved by the FDA. Generally, such use is allowed within guidelines called a treatment IND, when no comparable or satisfactory alternative drug or therapy is available.
In addition to the age and gender restrictions, the IND protocol for Zelnorm limits use of the drug to those with IBS-C or CIC whose physicians decide the drug is medically necessary. Patients must sign consent materials to ensure they are fully informed of the potential risks and benefits of Zelnorm.
On March 30, 2007, the FDA asked Novartis, the manufacturer of Zelnorm, to suspend its U.S. marketing and sales because a safety analysis found a higher chance of heart attack, stroke, and unstable angina (heart/chest pain) in patients treated with Zelnorm compared with treatment with an inactive substance (placebo).
At that time, the FDA indicated that there might be patients for whom the benefits of Zelnorm treatment outweigh the risks and for whom no other treatment options were available. FDA committed to work with Novartis to allow access to Zelnorm for those patients through a special program. That work yielded this IND protocol.
"These patients must meet strict criteria and have no known or pre-existing heart problems and be in critical need of this drug," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research (CDER). "Zelnorm will remain off the market for general use."
Irritable bowel syndrome is a disorder characterized most commonly by cramping, abdominal pain, bloating, constipation, and diarrhea. IBS causes a great deal of discomfort and distress, but it does not permanently harm the intestines and does not lead to disease. For some people, however, IBS can be disabling. They may be unable to work, attend social events, or even travel short distances.
Patients are considered to have chronic constipation if they have fewer than three complete spontaneous bowel movements per week and at least one of the following symptoms for at least 25 percent of those bowel movements: straining, hard stools, incomplete evacuation.
Physicians with IBS-C or CIC patients who meet the IND criteria should contact Novartis at 888- 669-6682 or 866-248-1348. Those who do not qualify for the Zelnorm treatment protocol may contact FDA’s Division for Drug Information about other options at 888-463-6332.
For more information:
Novartis Zelnorm Web page
National Institute of Diabetes and Digestive and Kidney Diseases—Irritable Bowel Syndrome
International Foundation for Functional Gastrointestinal Disorders
FDA Center for Drug Evaluation and Research
替加色罗的此次重新上市，可能与此类药物治疗人群的强烈建议分不开。
由于缺乏相应的药物替代，虽有风险，患者使用替加色罗的决心将促使替加色罗仍旧活跃在临床上。
以下为我对新闻的粗略翻译，错误不少，仅供参阅
美国食品及药物管理局宣布，它是准许在治疗探索性临床新药研究(IND)协议下限制使用马来酸替加色罗，以治疗肠易激综合症、慢性特发性便秘，而女性年轻55岁以上符合特定的准则。在某些事例上，没有参加临床试验但患者严重或威胁生命的疾病或状况的人可能使用未被FDA批准的药品。一般来说,当没有可比性或令人满意的替代药物或疗法可用，这种使用是被允许的，这称作IND治疗。 除了年龄和性别限制， IND议定书限制泽马可用于患有肠易激综合症和慢性特发性便秘病人，且病人的治疗医师认为泽马可的使用是医学必须的。病人必须签署同意材料，以确保他们充分了解潜在的风险和益处。
对2007年3月30日，美国食品药品管理局要求诺华制药暂停其在美国的市场和销售泽马可，因为一个安全分析后发现与安慰剂相比，使用泽马可增加患心脏病、中风、心绞痛的风险。 当时， 药物管理局表示，对那些有可能通过治疗身上所得受益大于风险和没有其它治疗方案的病人是可用的。 FDA同诺华一起致力于通过一个特别程序允许这些患者使用泽马可。这项工作就是ind协议书。“这些患者必须符合严格的标准，也没有任何已知或原有心脏问题，并急需这种药物，”史蒂文说（医学博士,药品评价和研究中心主任）“泽马可仍将从市场上普遍使用” 。肠易激综合症是一种疾病，最常见的腹胀、腹痛、腹胀、便秘、腹泻等症状。 激造成极大的不适和痛苦， 但这并不永久伤害肠胃，并不会导致疾病。 然而一些患者可因此致残。 他们可能会无法工作，参加社交活动，甚至短途旅行。病人每周少于三个完整自发大便，并至少其中有下列症状（至少25 %的大便straining， hard stools， incomplete evacuation）之一者，可认为有慢性便秘。
。。。。。。
合合合合
国内的替加色罗根本就没退过市,
还有加替沙星,副作用很大,就是不退市.
FDA Permits Restricted Use of Zelnorm for Qualifying Patients
The U.S. Food and Drug Administration announced that it is permitting the restricted use of Zelnorm (tegaserod maleate) under a treatment investigational new drug (IND) protocol to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55 who meet specific guidelines.
In some instances, patients with a serious or life-threatening disease or condition who are not enrolled in a clinical trial may be treated with a drug not approved by the FDA. Generally, such use is allowed within guidelines called a treatment IND, when no comparable or satisfactory alternative drug or therapy is available.
In addition to the age and gender restrictions, the IND protocol for Zelnorm limits use of the drug to those with IBS-C or CIC whose physicians decide the drug is medically necessary. Patients must sign consent materials to ensure they are fully informed of the potential risks and benefits of Zelnorm.
On March 30, 2007, the FDA asked Novartis, the manufacturer of Zelnorm, to suspend its U.S. marketing and sales because a safety analysis found a higher chance of heart attack, stroke, and unstable angina (heart/chest pain) in patients treated with Zelnorm compared with treatment with an inactive substance (placebo).
At that time, the FDA indicated that there might be patients for whom the benefits of Zelnorm treatment outweigh the risks and for whom no other treatment options were available. FDA committed to work with Novartis to allow access to Zelnorm for those patients through a special program. That work yielded this IND protocol.
"These patients must meet strict criteria and have no known or pre-existing heart problems and be in critical need of this drug," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research (CDER). "Zelnorm will remain off the market for general use."
Irritable bowel syndrome is a disorder characterized most commonly by cramping, abdominal pain, bloating, constipation, and diarrhea. IBS causes a great deal of discomfort and distress, but it does not permanently harm the intestines and does not lead to disease. For some people, however, IBS can be disabling. They may be unable to work, attend social events, or even travel short distances.
Patients are considered to have chronic constipation if they have fewer than three complete spontaneous bowel movements per week and at least one of the following symptoms for at least 25 percent of those bowel movements: straining, hard stools, incomplete evacuation.
Physicians with IBS-C or CIC patients who meet the IND criteria should contact Novartis at 888- 669-6682 or 866-248-1348. Those who do not qualify for the Zelnorm treatment protocol may contact FDA’s Division for Drug Information about other options at 888-463-6332.
For more information:
Novartis Zelnorm Web page
National Institute of Diabetes and Digestive and Kidney Diseases—Irritable Bowel Syndrome
International Foundation for Functional Gastrointestinal Disorders
FDA Center for Drug Evaluation and Research
替加色罗的此次重新上市，可能与此类药物治疗人群的强烈建议分不开。
由于缺乏相应的药物替代，虽有风险，患者使用替加色罗的决心将促使替加色罗仍旧活跃在临床上。
以下为我对新闻的粗略翻译，错误不少，仅供参阅
美国食品及药物管理局宣布，它是准许在治疗探索性临床新药研究(IND)协议下限制使用马来酸替加色罗，以治疗肠易激综合症、慢性特发性便秘，而女性年轻55岁以上符合特定的准则。在某些事例上，没有参加临床试验但患者严重或威胁生命的疾病或状况的人可能使用未被FDA批准的药品。一般来说,当没有可比性或令人满意的替代药物或疗法可用，这种使用是被允许的，这称作IND治疗。 除了年龄和性别限制， IND议定书限制泽马可用于患有肠易激综合症和慢性特发性便秘病人，且病人的治疗医师认为泽马可的使用是医学必须的。病人必须签署同意材料，以确保他们充分了解潜在的风险和益处。
对2007年3月30日，美国食品药品管理局要求诺华制药暂停其在美国的市场和销售泽马可，因为一个安全分析后发现与安慰剂相比，使用泽马可增加患心脏病、中风、心绞痛的风险。 当时， 药物管理局表示，对那些有可能通过治疗身上所得受益大于风险和没有其它治疗方案的病人是可用的。 FDA同诺华一起致力于通过一个特别程序允许这些患者使用泽马可。这项工作就是ind协议书。“这些患者必须符合严格的标准，也没有任何已知或原有心脏问题，并急需这种药物，”史蒂文说（医学博士,药品评价和研究中心主任）“泽马可仍将从市场上普遍使用” 。肠易激综合症是一种疾病，最常见的腹胀、腹痛、腹胀、便秘、腹泻等症状。 激造成极大的不适和痛苦， 但这并不永久伤害肠胃，并不会导致疾病。 然而一些患者可因此致残。 他们可能会无法工作，参加社交活动，甚至短途旅行。病人每周少于三个完整自发大便，并至少其中有下列症状（至少25 %的大便straining， hard stools， incomplete evacuation）之一者，可认为有慢性便秘。
。。。。。。
合合合合
国内的替加色罗根本就没退过市,
还有加替沙星,副作用很大,就是不退市.