有关肠道清洗剂的警告
2009-05-26 20:37:38   来源：   作者：  评论：0 点击：

FDA is announcing new safety measures for oral sodium phosphate (OSP) products used for bowel cleansing before colonoscopies and other procedures. These products are associated with acute phosphate nephropathy, a rare but serious type of kidney injury. The events have been reported with the prescription products Visicol and OsmoPrep, and also over-the-counter sodium phosphate products when they are used as bowel cleansers. FDA就口服磷酸钠（OSP）产品宣布了新的安全措施，OSP用于结肠镜检查和其他程序前的肠道清洗。这些产品跟急性磷酸肾病----一种罕见但是严重的肾损伤有关联。相关报道事件涉及作为肠道清洗剂的处方药物Visicol 和OsmoPrep，以及磷酸钠等非处方药物。

FDA first warned about this problem in 2006, but cases of kidney injury continue to be reported. So FDA is requiring the manufacturer of Visicol and OsmoPrep to take several steps. First, a boxed warning about the risk of acute phosphate nephropathy will be added to the product label. The manufacturer will also conduct a new clinical trial to further study the risk of acute kidney injury with these products, provide a Medication Guide for patients, and implement a risk evaluation and mitigation strategy to ensure that the benefits of using these products outweigh their risks. 2006年FDA首次警告这种问题，但是肾损伤事件持续被报道。所以FDA要求Visicol 和 OsmoPrep的生产厂家采取一些措施。首先，将急性磷酸肾病的黑框警告加到产品标签上。生产商需要进行新的临床试验进一步研究这些产品的急性肾损伤的风险，为病人提供用药指导，完成风险评价，以确定使用这些产品的意义大于存在的风险。

FDA believes that oral sodium phosphate products should be available only by prescription when they are used for bowel cleansing. Because of this, C.B. Fleet Company has voluntarily recalled the company's oral sodium phosphate products sold over the counter, (Fleet Phospho-soda and Fleet EZ-PREP) and has advised healthcare professionals not to instruct patients to use these products for bowel cleansing. Unico Holdings, Inc. is also recalling its OTC oral sodium phosphate products sold for bowel cleansing. FDA认为口服磷酸钠产品作为肠道清洗剂时只能通过处方获得。因此，C.B. Fleet公司主动召回了其作为非处方销售的口服磷酸钠产品(Fleet Phospho-soda and Fleet EZ-PREP)，并且建议保健专家不给病人推荐这些产品用于肠道清洗。Unico Holdings公司也将召回其用于肠道清洗的OTC磷酸钠产品。

Health professionals should use caution when prescribing Visicol or OsmoPrep for patients who may be at higher risk of kidney injury. This includes those over aged 55, or those who have kidney disease, bowel obstruction, active colitis, or are dehydrated. It also includes patients taking drugs that affect renal perfusion or function such as diuretics, ACE inhibitors, angiotensin receptor blockers (ARBs) and possibly NSAIDS.保健专家在给可能存在肾损伤高风险的病人开Visicol 或 OsmoPrep处方时，需要小心谨慎。这些病人包括年纪大于55岁，或者患有肾疾病、肠梗阻、活动期结肠炎、或脱水患者；也包括正在服用影响肾灌注或肾功能药物的患者，此类药物如利尿剂、ACE抑制剂、血管紧张素受体抑制剂(ARBs)、或许NSAIDS。

Prescribers should instruct patients about how to prepare for their procedures, and tell them to avoid dehydration by drinking enough clear liquids before, during and after bowel preparation. They should also tell patients to be alert for symptoms of acute kidney injury, including malaise, lethargy, drowsiness, decreased urine volume and swelling of the ankles, feet and legs. 处方医生应该指导病人如何为其过程做准备，并告知病人在肠道准备前、中、后饮用足够量的干净液体以防止脱水。医生也应该告诉病人使其警惕急性肾损伤的症状：不适、嗜睡、困倦、尿容量减少以及脚踝和腿肿胀。

Additional Information: 附注：

FDA MedWatch Safety Alert. Oral Sodium Phosphate (OSP) Products for Bowel Cleansing (marketed as Visicol and OsmoPrep, and oral sodium phosphate products available without a prescription). December 11, 2008. FDA药品监督网页安全警告。肠道清洗用口服磷酸钠（OSP）（市售产品为Visicol 和 OsmoPrep，以及不需要处方即可获得的口服磷酸钠产品）。