警告: 谨慎使用博士伦的润明Renu隐形眼镜护理液--博士伦公司将主动暂停旗下润明护理液的发货

[贾队长（小拿）]

博士伦公司将主动暂停旗下润明护理液的发货

http://www.enorth.com.cn　 2006-04-12 08:04
　


专题：博士伦风波 润明ReNu护理液疑引发角膜炎

　　美国食品药物管理局(FDA)昨天宣布，由于被怀疑可能与眼部罕见疾病相关，博士伦公司将主动暂停旗下润明护理液的发货。而博士伦北京总公司相关人士表示，中国地区暂未收到停货通知。

　　感染源暂时没有确定FDA周一在其官方网站发布声明，告诫医生和佩戴软性隐形眼镜的患者，感染镰胞菌角膜炎的病例越来越多。这种疾病可能导致患者永久性失明，有些患者需要做角膜移植手术。



　　FDA和美国疾病预防控制中心(CDC)表示，截至本月9日，全美已发现109例感染者，其中30位患者接受了美国疾病防治中心以及美国食品和药物管理局等部门的医疗调查。而根据CDC的数据，这些患者中有28人配戴隐形眼镜，其中26例据报使用过博士伦公司的隐形眼镜药水或其仿制品。

　　声明同时强调，并非所有病例报告都涉及博士伦产品，目前还无法确定这种造成眼部感染的真菌来自何处；不良的卫生习惯或超长时间佩戴隐形眼镜等因素也有可能造成感染。

　　博士伦公司当天在纽约证券交易所的股票价格创下52周以来最低点。据博士伦公司介绍，“润明”护理液在美国市场2005年的销售额约为4500万美元。

　　今年早些时候，因引发眼角膜真菌炎问题，新加坡和马来西亚相继禁止销售博士伦“润明”护理液。

　　中国暂未收到停货通知

　　虽然感染源暂未确认，但CDC及新加坡的某些数据令润明护理液被疑可能引发感染。FDA宣布，博士伦已经同意暂停隐形眼镜药水润明的发货，直到相关调查结束。

　　博士伦董事长罗纳德・扎雷拉接受媒体采访时说，眼科感染疾病的报告“纷繁复杂”，美国生产的润明护理液显然被不合比例地大量提及。

　　博士伦北京总公司陈先生表示：“我们也是从国外媒体上看到这个消息的。目前还没有接到任何通知，不清楚是否包含中国地区；单从报道内容看，停货可能是针对美国市场的。”他表示，“由于时差问题，暂时没有和美国总公司联系上。

　　只要收到消息，我们会积极应对。”

　　药监部门支持暂停发货

　　国家食品药品监督管理相关人员得知“暂停发货”消息后，对晨报表示：“发现产品有缺陷应该责令改正，他们现在主动改正是好事。”但该人士拒绝就润明护理液是否会引发眼部感染发表评论。

　　上海药监局办公室主任陈先生在接受晨报采访时说：“根据我们的检测，目前还没有发现在中国销售的博士伦护理液存在问题。但他们自愿停止发货我们是支持的，说明这个公司是比较负责任的。”他同时表态，一旦权威机构确认产生问题的原因，上海将积极跟进，进行监督管理，或者强制要求召回产品。

稿源： 新闻晨报 编辑： 张晋

http://economy.enorth.com.cn/system/2006/04/12/001278862.shtml

CCTV的新闻频道也有报道.

 

[贾队长（小拿）]

FDA( Food and Drug Administration )网站 http://www.fda.gov/

FDA News
FOR IMMEDIATE RELEASE
P06-56
April 10, 2006
Media Inquiries:
Susan Cruzan, 301-827-6242
Consumer Inquiries:
888-INFO-FDA



Investigation of Serious Eye Infections Associated With Soft Contact Lens Use and Contact Lens Solution
Consumers Are Advised to Follow Good Hygiene Practices and Manufacturers’ Instructions to Prevent Infection
The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are alerting health care professionals and their patients who wear soft contact lenses to an increasing number of reports in the United States of rare but serious fungal infections in the eye that can cause permanent loss of sight. Some patients have reported a significant loss of vision, resulting in the need for a corneal transplant.

A fungus called Fusarium has been identified as the cause of the reported infections. As of April 9, 2006, 109 cases of suspected Fusarium keratitis are under investigation by CDC and public health authorities in 17 states of the U.S.

"This is a serious infection and soft contact lens users should be mindful of the potential to develop this problem," said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health. "We're advising consumers to practice good basic hygiene and follow manufacturers' instructions for proper use, cleaning and storage of their lenses, and report any signs of infection to their doctors."

Clinicians who evaluate patients with microbial keratitis should consider that a fungal infection may be involved and refer the patient to an ophthalmologist, if appropriate to obtain a specimen for laboratory analysis. In addition, the FDA and CDC are urgently advising consumers to take precautions to prevent contamination of the soft lenses and the products used to maintain them. These preventive practices for contact lens wearers include the following:

Wash hands with soap and water, and dry (lint-free method) before handling lenses.
Wear and replace lenses according to the schedule prescribed by the doctor.
Follow the specific lens cleaning and storage guidelines from the doctor and the solution manufacturer.
Keep the contact lens case clean and replace every 3-6 months.
Remove the lenses and consult your doctor immediately if you experience symptoms such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge or swelling.
In addition, regardless of which cleaning/disinfecting solution used, wearers may want to consider performing a "rub and rinse" lens cleaning method, rather than a no rub method, in order to minimize the number of germs and reduce the chances of infection.

Of the 30 patient cases fully investigated so far, 28 wore soft contact lenses and two reported no contact lens use. Twenty-six of the soft contact lens users who remembered which solution they used during the month prior to the infection onset reported using a Bausch & Lomb ReNu brand contact lens solution or a generic brand manufactured by the same company. Five case-patients reported using other solutions in addition to the ReNu brand, and 9 patients reported wearing contact lenses overnight, a known risk factor for microbial keratitis.

"It is important to note that some of the affected patients had used other solutions in addition to the ReNu brand, and that the source of this fungus has not yet been identified. But we're working with CDC and Bausch & Lomb -- and we're investigating other possible causes -- to prevent these infections," Dr. Schultz added.

Bausch and Lomb has informed FDA that they are voluntarily stopping shipment of the ReNu Moisture Loc product while they are continuing to investigate the cause of these infections. Soft contact lens users who have existing supplies of the Renu Moisture Loc should use the product with caution and report any signs and symptoms of eye infection to their doctors.

Clusters of Fusarium keratitis were reported among contact lens users in Asia beginning in November 2005. In February 2006, Bausch & Lomb voluntarily suspended sales of its ReNu multipurpose solutions in Singapore and Hong Kong after multiple reports of the infection among contact lens users there. No other jurisdictions have taken similar action to date.

Fusarium species are normally found in many plants, soil, and tap water. The annual risk of contact lens-related microbial keratitis is estimated in most studies to be between four and 21 per 10,000 patients, depending on whether the lenses are worn only during the day or continuously overnight.

Fungal keratitis can be associated with trauma to the surface of the eye, immunodeficiencies, and contact lens use. Organisms associated with contact lens-related keratitis are usually bacteria rather than fungus, often arising from contamination of lens care products or from contact lens storage cases.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01354.html

 

[贾队长（小拿）]

真菌性角膜炎是一种致盲率较高、治疗较为棘手的感染性眼病。角膜是透明、无血管分布的组织，一旦感染真菌后，真菌就会垂直和平行生长，加速角膜病变的发展。药物不能通过血管直接作用于角膜病变区，因此真菌性角膜病变往往迁延不愈，甚至导致角膜溃疡、穿孔。一旦出现角膜溃疡、穿孔，应及时做角膜移植手术。由于我国同种异体角膜来源匮乏，重症患者难以保住眼球。

 

[贾队长（小拿）]

大家果然很关心中国,

对中国产品产生问题的状况关心, 对北美的不关心.

 

[qiyuan]

这个国内差不多一个半月前就报道了 柜台上都撤了
家里还特意打电话来说 不可以再用博士伦

 

[Amanda75]

omg, I am still using it...