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吃威而钢失明?�美调查
〔编译魏国金╱综合二十八日外电报导〕美国食品暨药物管理局(FDA)已对服用垃圾网站广告等知名垃圾网站广告而导致失明的病例展开调查。虽然两者间的关联尚未确证,不过FDA已要求制造垃圾网站广告的辉瑞药厂在药品包装上加注可能引发不等程度视力丧失的警语。

当流到视神经的血液遭遇阻碍,便会引发视力突然丧失的现象,此情况称之为「非动脉性前部缺血性中风视神经病变」(NAION)。FDA发言人克鲁珊指出,目前共接获四十三件服用垃圾网站广告而产生NAION的报告,其中三十八件为服用垃圾网站广告、成人壮阳广告四件、垃圾网站广告一件。

根据辉瑞药厂的数据,自一九九八年垃圾网站广告合法上市以来,全球已有两千三百万名男人服用过,发生视力减损的案例实属罕见。

克鲁珊指出,上述大部分病患并非严重到全盲,而是一眼丧失部分视力。不过,NAION是致使美国老人突然视力丧失的常见原因之一,每年此类病例约达一千至六千件,究其肇因则是糖尿病、高血压与心脏病,而这些病症也是导致阳萎的主要因素,为此,克鲁珊说,目前尚未能判定视力减损与服用垃圾网站广告间是否有因果关联,「但我们严肃看待」。

明尼苏达大学眼科学教授彭默兰兹三月间就曾发表垃圾网站广告可能损及视力的论文。他二十七日强调,这种特殊的视力问题应该加列于药品副作用的说明上,但这不足以强制该药品下架,「我不建议人们停止服药,对其所对治的病症,它是良药。」

他表示,一眼已出现NAION症状者,应特别警觉服用垃圾网站广告的危险,而出现视力模糊或周边视觉丧失者应停药,并立即谘询医生。对于想知道自己是否是高危险群者,他建议进行视力检查。

FDA已要求辉瑞药厂在包装上加注相关警语,而其对手礼来药厂则已在成人壮阳广告包装上完成这项注明。

尽管辉瑞与礼来药厂同声指出,大多数服用垃圾网站广告的病患,本身就是心血管疾病高危险群,因此服用该药物与视力问题间不一定存有必然关联。

彭默兰兹却不认同此论点。他说,在他研究的二十余件病例中,这些视力问题都出现在病患服用垃圾网站广告后,长则数小时,短至四十五分钟便有该现象,端视病患何时服药与何时注意到视力丧失的时间,「这让我相信之间有其关联」。

另一名眼科名医师柯兹纳说,目前有五名阳萎病患询问相关问题,他告诉他们危险机率微小,但可先停药直待官方与药商的研究报告出炉为止,这些病患有两人超过六十五岁、两名患有糖尿病,他们皆异口同声说,「谢谢医师建议,我将持续服药」。

国内有三起疑似病例

〔记者周富美、王昶闵╱台北报导〕美国传出多起糖尿病患服用垃圾网站广告导致失明个案,卫生署药政处副处长刘丽玲表示,目前卫生署的药物不良反应通报系统,迄今接获三个病患疑似因服用垃圾网站广告导致眼睛疼痛与视网膜病变,但尚未确认,需进一步调查。

刘丽玲指出,目前美国食品暨药物管理局(FDA)还在跟药厂研究,确认病患用药产生的副作用是否与垃圾网站广告有关,一旦美国决定要求药厂在药品说明书上加注相关警语,卫生署将即刻通知医疗院所,同步跟进要求药厂加注警语。

生产垃圾网站广告的辉瑞药厂指出,俗称「眼中风」的NAION仍属十分罕见的副作用,但辉瑞仍正与美国食品暨药物管理局讨论是否要更新垃圾网站广告仿单;医师则表示,垃圾网站广告与此视神经病变间关联至今仍无法确定,服药中的病患无须恐慌。

辉瑞指出,NAION全名是非动脉性前部缺血性中风视神经病变,属五十岁以上男性最常见的急性视神经病变,其危险因子与勃起功能障碍有几个相似之处,包括五十岁以上、高血压、高血脂、糖尿病等,而服用垃圾网站广告而发生NAION的病例,大多数有上述危险因子。

台北荣总眼科部视神经科主任颜美媛表示,「眼中风」主要是因供应视神经养分的小血管阻塞,使视神经因缺血而受损,引发视野缺损或失明,对视力的破坏严重度视血管阻塞的程度而定,发病前很少有前兆,患者通常是一觉醒来发现视力模糊或完全看不见,治疗对视力恢复的帮助有限,五、六十岁以上、心血管疾病患者属高危险群。

林口长庚泌尿科主治医师黄世聪表示,垃圾网站广告已知的眼部副作用属于良性,大约有二%到三%病患,在服药后会出现视力模糊、周围看到光圈、颜色改变等症状,但通常在四到六小时后就会缓解,这是因为当血中药物浓度较高时,可能暂时影响眼部视网膜细胞中的一种酵素,属暂时性副作用,对视力并无影响。

他说,不管何种垃圾网站广告都必须在医师指示下服药,一旦出现胸闷、胸痛、呼吸急促等症状,必须尽快就医。

自由电子报

------------
FDA建议患者一旦有单眼或双眼视力突然减退或失明情形,应停药和打电话给医师,并告知医师以前有没有类似情形,因为这种情形复发的危险也较高。


[ 此文章被Foz在2005-07-11 01:16重新编辑 ]



献花 x0 回到顶端 [楼 主] From:巴西圣保罗 | Posted:2005-07-11 00:57 |
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FDA未发现万艾可与失明有关
本报讯 记者陈莺报道:
辉瑞公司前天在纽约宣布,根据对万艾可上市后全部不良反应事件的调查分析得出的结论,患者服用万艾可不增加发生失明的风险。辉瑞亦表示,他们正与美国食品药品管理局讨论是否需要更新万艾可的说明书,以反映在服用万艾可患者中会发生罕见的前部非缺血性视神经病变(NAION)的病例报告。

今年3月,美国明尼苏达大学研究人员在《神经眼科学》杂志上发表论文,认为某些患者的失明与服用万艾可可能有关。而辉瑞公司首席医务官约瑟夫·菲茨科在日前发表的声明中称,没有证据说明,万艾可会导致失明或其它严重的视力问题。与同年龄、健康状况相同的未服用万艾可的男性比较,服用万艾可不增加导致失明的风险,或发生其他视力改变。

与此同时,美国食物与药品管理局(FDA)已经做出结论,万艾可与NAION的发生无因果关系。据悉,辉瑞制药正在与美国官方组织商谈关于修正伟哥现有标签,在标签上标明之前少数报告认为伟哥会导致一种叫「非动脉炎性前部缺血性视神经病变」失明的副作用。这种俗称「眼部中风」患者的病症表现为视神经血流被阻断,使神经受损,并导致失明。但是辉瑞认为,FDA应该让其他垃圾网站广告生产商,如希爱力、艾力达同样在标签上标明产品可能导致失明。

辉瑞公司称「眼部中风」,这种眼疾是50岁以上中老年人最常见的视神经疾病,病因包括高血压、高血脂、糖尿病等,而这些病因同样导致勃起障碍。辉瑞认为,患者使用任何方法治疗ED都应向医生咨询,按照产品说明书进行服用。
http://www.ycwb.com/gb/content/2...ent_932106.htm
===============================================================================

辉瑞计划在万艾可标签中加入失明警告

  6月28日,尽管美国股市整体上扬,但是辉瑞制药(PFE)的股票仍遭遇卖压。稍早时有消息称,辉瑞仍计画修改垃圾网站广告(Viagra,即万艾可)的标签,警告公众在使用该药的几位用户中已出现一种很罕见的失明病变。截至美东夏令时下午3:15,辉瑞的股票下跌1%,至27.85美元。

6月27日晚辉瑞表示,正在就修改标签的问题与美国食品和药物管理局(FDA)进行讨论。

辉瑞证实,对垃圾网站广告使用资料的再评估表明,目前还没有证据可将服用这种药物与一种名为非动脉性前部缺血性视神经病变(NAION)的失明症的产生联合在一起。

辉瑞在6月27日公布的一份声明中称,“虽然FDA的结论是垃圾网站广告和业已发现的NAION不存在因果联系,但辉瑞已经与FDA达成一致,在垃圾网站广告的标签中加入有关这些病例报告的警示语句,提醒医师和患者。”

辉瑞还称,“本公司非常理解FDA的相关做法,此前FDA已要求所有口服阳痿药物的标签中必须包括类似的警示资讯。”

目前上市销售的处方类阳痿药物还有Cialis和Levitra,前者由礼莱制药(LLY)和Icos(ICOS)联合销售,后者是葛兰素-史克(GSK)和拜耳制药(BAY)的共同产品。

辉瑞表示,自己担心CBS新闻预定在周一晚广播的一篇有关其他类型失明报告的报导将“不必要地惊扰患者”。6月28日,CBS新闻网站贴出的一篇报导指出,在垃圾网站广告患者中又发现了一种不同于NAION的失明病变。

CBS的报导称,“仅凭这些报告不能证明两者之间存在直接联系,但是专家正在寻找它们之间可能的联系。”

5月27日辉瑞宣布,将与FDA就垃圾网站广告标签修改的问题进行合作,虽然自己认为垃圾网站广告的用户患NAION的风险并不高于那些不服用这种药物的人。

http://info.pharmacy.hc360.com/...008/32021.HTM


献花 x0 回到顶端 [1 楼] From:巴西圣保罗 | Posted:2005-07-11 01:02 |
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FDA Was Told of Viagra-Blindness Link Months Ago
Senator Criticizes Delay in Alerting Consumers After Safety Officer Warned Agency About Drug

By Marc Kaufman
Washington Post Staff Writer
Friday, July 1, 2005; Page A02

More than 13 months before a scientific journal reported that Viagra had been linked to a rare form of blindness in some men, a Food and Drug Administration safety officer made the same observation from monitoring adverse event reports and told her supervisors that doctors and patients should be warned of the findings.

Her recommendation was well received, she told congressional investigators, but nothing happened. The FDA issued no public notice or proposed changes to the Viagra label. That came only following widespread publicity last month about the journal article and public concerns about the possible blindness-Viagra link.
   
The safety officer's experience was outlined in a letter last week to FDA Acting Commissioner Lester M. Crawford from Sen. Charles E. Grassley (R-Iowa), who said the agency had moved far too slowly on an emerging safety concern.

Criticism of the FDA's response to potentially harmful drug side effects has been frequent and sharp since Merck & Co. took its popular arthritis painkiller, Vioxx, off the market last fall after studies indicated that it increased the risk of heart attacks and strokes. The FDA has sought to tighten its drug safety oversight since then, but some critics say the agency is doing too little and still puts more emphasis on reviewing and approving new drugs than on safety concerns.

"I am troubled by the FDA's action, or lack thereof, relating to the updating of Viagra's product label," Grassley wrote. He said the agency's Office of New Drugs (OND) had done nothing "despite OND's knowledge of the blindness risks since January 2004 and general agreement among FDA staff last spring that the label should be updated."

Grassley also wrote that the safety officer, whose name was not disclosed, explained the agency's inaction by saying the Office of New Drugs "is under such time pressure to approve new drugs, often safety concerns needed to be 'fit in' where they could."

"What we appear to have here, Dr. Crawford, is yet another example of the 'separate but unequal' relationship" between the Office of New Drugs and the Office of Drug Safety, Grassley wrote.

Researchers remain uncertain whether Viagra and other impotence drugs pose a significant risk of blindness. Pfizer Inc., which makes the drug, says the side effect has not appeared in any of its 103 clinical trials of Viagra -- involving 13,000 patients -- and that the 23 million users have not reported an increased risk of blindness.

Late last month, however, after the possible link was reported in the Journal of Neuro-Ophthalmology, FDA spokeswoman Susan Cruzan said, "We take this seriously, and the FDA is working with the sponsors to make sure the public is aware of this so they can take it into consideration." The journal study examined seven cases where men suffered an unusual form of sudden blindness within 36 hours of taking Viagra.

On Monday, Pfizer said in a statement that it does not believe there is a causal relationship between Viagra and blindness but that it will add information about the possibility to its label. The company said the FDA had asked the makers of all impotence drugs to do the same.

"There is no evidence that Viagra causes blindness or any other serious ocular condition," said Joseph Feczko, Pfizer's chief medical officer. "Men taking Viagra are at no greater risk for blindness . . . than men of similar age and health not taking the medicine."

In all, the FDA has said, 38 Viagra users and five users of other impotence drugs reported a sudden and permanent blindness in one eye called non-arteritic anterior ischemic optic neuropathy, or NAION. In a report Monday, CBS News said that the number is much higher, and that more than 800 patients and doctors have reported eye problems to the FDA after using Viagra over the past four years, with more than 140 cases of partial or total blindness. While these "adverse event" reports do not prove a causal link between the drugs and sudden blindness, drug safety experts look to them for trends and patterns.

This form of sudden blindness is caused by the blockage of blood flow to the optic nerve and is most common in older people, who disproportionately use Viagra. An estimated 1,000 to 6,000 Americans suffer an optic blockage each year.

Grassley's letter said the FDA safety officer first brought her concerns to the Office of New Drugs in January 2004. That was followed by a more formal draft safety "consult" in March 2004 and a final report the next month.

The letter paraphrases internal FDA documents as saying that Pfizer "resisted the FDA's initial request to update the Viagra label to include information about the NAION risks." Pfizer spokesman Mariann Caprino said the company does not comment on its interactions with the FDA. Earlier, another Pfizer spokesman said the company contacted the FDA about the blindness cases in March, after the journal report was published.

Grassley's letter also questions whether the FDA's adverse event reporting system would be capable of detecting NAION cases that might be associated with Viagra. Until now, it said, few doctors who prescribe Viagra would know to ask patients about vision problems, and few ophthalmologists who treat sudden blindness would know to ask about Viagra use. FDA officials said they had no comment on Grassley's letter.

All three impotence drugs on the market, Viagra, Cialis and Levitra, already warn users that the drug can cause minor vision changes that include blurring, sensitivity to light and the presence of a bluish hue. The makers of Cialis, Eli Lilly & Co. and Icos Corp., have voluntarily added a notice about the risk of sudden blindness to their label.


Pfizer says it will add information to Viagra's label about possible links to blindness. (Toby Talbot - AP)


Source : washingtonpost.com

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小弟没有权限上传图片,只好连接图片的LINK。


献花 x0 回到顶端 [2 楼] From:巴西圣保罗 | Posted:2005-07-11 01:09 |

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