美国食品和药品管理局宣布，处于审查中的新药Zelnorm（马来酸替加色罗）可以有限制的应用于年龄小于55岁的肠易激综合征和慢性特发性便秘患者。
一些情况下，患有严重威胁生命疾病的患者，不被招募入临床试验，但是可以用未被FDA批准的药物治疗。一般的，在没有相当的，或者满意的替代药物或疗法的情况下，这种药物在治疗性新试验药指导方针下是允许的。
除了对年龄和性别限制，Zelnorm的新试验药指导方针规定，只能应用于医生认为医学上有必要的肠易激综合征和慢性特发性便秘患者。患者必须签署知情同意书，以确保他们完全了解Zelnorm的益处，以及潜在的危险。
2007年3月30日，FDA要求Zelnorm的生产商诺华公司停止其在美国的销售，因为一项安全性分析发现。使用Zelnorm的人患心脏病发作，中风，不稳定心绞痛的机会比使用无活性物质（安慰剂）的人高。
与此同时，FDA也发现，存在使用Zelnorm利大于弊的患者和没有其他治疗方法可以选择的患者。FDA与诺华公司合作，允许Zelnorm应用于新试验药指导方针规定的患者。
FDA药物评估研究中心负责人Steven Galson博士说，患者必须经过严格的检查，没有已知或预先存在的心脏病，并且急需这个药物。Zelnorm仍然禁止作为一般应用在市场销售。
肠易激综合征是一种以痉挛，腹痛，胃气胀，便秘，腹泻为特征的疾病。慢性特发性便秘带来一系列不适和苦恼，但是不会造成肠道永久性损害和引起疾病。然而，有些慢性特发性便秘患者可能因此残疾。他们不能工作，残疾社交活动，甚至短途旅行。
如果每周少于3次自发的大便，而且25％的大便中有以下症状之一者，可以诊断为慢性便秘：大便用力，硬粪，排便不完全。
有患者是肠易激综合征和慢性特发性便秘的医生可以通过888- 669-6682 或 866-248-1348联系诺华公司索取新试验药指导方针。不符合Zelnorm新试验药指导方针的患者可以致电888-463-6332.向FDA药物信息部门咨询其他方法。
原文
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.
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