FDA News
美国食品药品局（FDA）新闻
FOR IMMEDIATE RELEASE
即时发布
P06-192
December 5, 2006
2006年12月5日
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媒体调查
Cathy McDermott, 301-827-6242
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消费者调查
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FDA Warns Five Firms To Stop Compounding Topical Anesthetic Creams
FDA警告五个公司停止合成表面麻醉剂
The Food and Drug Administration (FDA) is warning five firms, Triangle Compounding Pharmacy, University Pharmacy, Custom Scripts Pharmacy, Hal’s Compounding Pharmacy, and New England Compounding Center, to stop compounding and distributing standardized versions of topical anesthetic creams, which are marketed for general distribution rather than responding to the unique medical needs of individual patients. Firms that do not resolve violations in FDA warning letters risk enforcement such as injunctions against continuing violations and seizure of illegal products.
FDA警告五个公司停止合成和发售标准版的表面麻醉剂，，五个公司分别是三角合成药业、大学合成药业、海关药业、Hal’s 合成药业和新英格兰合成中心。这些合成表面麻醉剂是作为普通供应而市场化，不是对于贴别的病人的特别的药品。这些公司不解决FDA警告信内说的违章行为 而冒险执行继续生产不合法产品。
FDA is concerned about the serious public health risks related to compounded topical anesthetic creams. Exposure to high concentrations of local anesthetics, like those in compounded topical anesthetic creams, can cause grave reactions including seizures and irregular heartbeats. Two deaths have been connected to compounded topical anesthetic creams made by Triangle Compounding Pharmacy and University Pharmacy, two of the five pharmacies receiving warning letters. Similar topical anesthetic creams are compounded by the other firms, and today’s action serves as a general warning to firms that produce standardized versions of these creams.
FDA担心和合成表面麻醉剂相关的严重公众健康危险。暴露在象那些在合成表面麻醉剂中那样的高浓度局麻药能导致严重反应如癫痫发作和心律失常。两个人死亡和三角、大学合成药业生产的合成表面麻醉剂相关，这两个公司收到了警告信。被其他公司合成的相似的表面麻醉剂，还有今天的行动作为生产这些麻醉剂的公司的总的警告。
"Compounded topical anesthetic creams, like all compounded drugs, are not reviewed by FDA for safety and effectiveness, and are not FDA-approved. These high potency drugs may expose patients to unnecessary risk, especially when they are used without proper medical supervision,” said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research. FDA is advising consumers who have questions or concerns about compounded topical anesthetic creams to contact their health care providers.
FDA 中心的药物评估研究负责人Steven Galson 博士说：“合成表面麻醉剂和所有合成药一样没有经过FDA的安全及有效性评价也没有得到FDA的获准。这些高的效能可能暴露病人与不必要的危险中，特别是当在没有正确的药物指导下应用时。” FDA建议有问题或关心合成表面麻醉剂的有关者去和他们的健康提供者联系。
Compounded topical anesthetic creams are often used to lessen pain in procedures such as laser hair removal, tattoos, and skin treatments. They may be dispensed by clinics and spas that provide these procedures, or by pharmacies and doctors’ offices.
合成表面麻醉剂常用于在激光拔毛术，纹身和皮肤治疗。他们可能被提供这些服务的诊所和 开出，或是由药店和医生诊室开出。
These creams contain high doses of local anesthetics including lidocaine, tetracaine, benzocaine, and prilocaine. When different anesthetics are combined into one product, each anesthetic’s potential for harm is increased. This potential harm may also increase if the product is left on the body for long periods of time or applied to broad areas of the body, particularly if an area is then covered by a bandage, plastic, or other dressing.
这些麻醉剂含有高剂量的局麻药，包括利多卡因、丁卡因、苯佐卡因、丙胺卡因。当不同的麻醉药被混入一种产品中，每种麻醉剂潜在的有害作用增加。如果这种产品在体表存留时间长或在体表大面积应用时，特别是用后被绷带石膏或其他敷料覆盖时，这种潜在的有害作用将也增加 。
The risk of harm is even greater in small children, patients with pre-existing heart disease, and patients with severe liver disease.
有害作用在小孩、已有存在的心脏病病人、存在严重肝病病人甚至会更大。
FDA-approved topical anesthetic products are commercially available and properly labeled, and are regularly used in health-care settings. However, some pharmacies create their own standardized versions of these products, often including combinations of ingredients and ingredients at higher strengths than found in FDA-approved products, and often lacking appropriate warnings or directions for use.
FDA认可的表面麻醉剂是可用于当作商品的、正确标示的、在心脏监护情况下限制应用的。然而一些药厂生产他们版本的这些产品，并常包含多种成分，并且成分的作用比FDA许可的产品的作用强，并且经常缺少适合的应用警告和指导。
The five firms warned by FDA have stated that they produce their topical anesthetic creams as part of the practice of pharmacy compounding. Traditional pharmacy compounding typically involves pharmacies preparing drugs that are not commercially available, such as a unique medicine for a patient who is allergic to an ingredient in a FDA approved drug. This kind of compounding follows a physician’s decision that his or her patient has a special medical need that cannot be met by FDA approved drugs.
五个被FDA警告的公司声称它们生产它们自己的表面麻醉剂是作为药物合成的实践的一部分。传统的药物合成包括药房准备药，并没有商业化应用，比如对病人对FDA许可药的成分过敏的特别的药物。
FDA normally permits such traditional pharmacy compounding and the agency’s action is not targeting this practice. By contrast, FDA is concerned that the five firms receiving warning letters are behaving like drug manufacturers, not traditional compounding pharmacies, because they produce standardized versions of topical anesthetic creams for general distribution.
FDA通常允许这种传统药物合成，并且公司行为不针对这种实践，相反，FDA担心收到警告的五个公司现在的行为更像药物制造厂，不像传统的合成药店，因为他们生产用于普通发售的标准化的表面麻醉剂。
Consumers and health care professionals should notify FDA of any complaints or problems associated with compounded drugs, including compounded topical anesthetic products. These reports may be made to MedWatch, FDA’s voluntary reporting program, by phone at 1-800-FDA-1088, or online at www.fda.gov/medwatch/report.htm.
消费者和卫生专家应告诉FDA任何和合成药相关的抱怨和问题，包括合成表面麻醉剂。这些报告可被做成医学观察，FDA义务报告方案，通过电话：1-800-FDA-1088或在线www.fda.gov/medwatch/report.htm.
Warning Letter to Triangle Compounding Pharmacy (Cary, NC)
对三角合成药业警告信
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