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吃威而鋼失明?�美調查
〔編譯魏國金╱綜合二十八日外電報導〕美國食品暨藥物管理局(FDA)已對服用垃圾網站廣告等知名垃圾網站廣告而導致失明的病例展開調查。雖然兩者間的關聯尚未確證,不過FDA已要求製造垃圾網站廣告的輝瑞藥廠在藥品包裝上加註可能引發不等程度視力喪失的警語。

當流到視神經的血液遭遇阻礙,便會引發視力突然喪失的現象,此情況稱之為「非動脈性前部缺血性中風視神經病變」(NAION)。FDA發言人克魯珊指出,目前共接獲四十三件服用垃圾網站廣告而產生NAION的報告,其中三十八件為服用垃圾網站廣告、成人壯陽廣告四件、垃圾網站廣告一件。

根據輝瑞藥廠的數據,自一九九八年垃圾網站廣告合法上市以來,全球已有兩千三百萬名男人服用過,發生視力減損的案例實屬罕見。

克魯珊指出,上述大部分病患並非嚴重到全盲,而是一眼喪失部分視力。不過,NAION是致使美國老人突然視力喪失的常見原因之一,每年此類病例約達一千至六千件,究其肇因則是糖尿病、高血壓與心臟病,而這些病症也是導致陽萎的主要因素,為此,克魯珊說,目前尚未能判定視力減損與服用垃圾網站廣告間是否有因果關聯,「但我們嚴肅看待」。

明尼蘇達大學眼科學教授彭默蘭茲三月間就曾發表垃圾網站廣告可能損及視力的論文。他二十七日強調,這種特殊的視力問題應該加列於藥品副作用的說明上,但這不足以強制該藥品下架,「我不建議人們停止服藥,對其所對治的病症,它是良藥。」

他表示,一眼已出現NAION症狀者,應特別警覺服用垃圾網站廣告的危險,而出現視力模糊或周邊視覺喪失者應停藥,並立即諮詢醫生。對於想知道自己是否是高危險群者,他建議進行視力檢查。

FDA已要求輝瑞藥廠在包裝上加註相關警語,而其對手禮來藥廠則已在成人壯陽廣告包裝上完成這項註明。

儘管輝瑞與禮來藥廠同聲指出,大多數服用垃圾網站廣告的病患,本身就是心血管疾病高危險群,因此服用該藥物與視力問題間不一定存有必然關聯。

彭默蘭茲卻不認同此論點。他說,在他研究的二十餘件病例中,這些視力問題都出現在病患服用垃圾網站廣告後,長則數小時,短至四十五分鐘便有該現象,端視病患何時服藥與何時注意到視力喪失的時間,「這讓我相信之間有其關聯」。

另一名眼科名醫師柯茲納說,目前有五名陽萎病患詢問相關問題,他告訴他們危險機率微小,但可先停藥直待官方與藥商的研究報告出爐為止,這些病患有兩人超過六十五歲、兩名患有糖尿病,他們皆異口同聲說,「謝謝醫師建議,我將持續服藥」。

國內有三起疑似病例

〔記者周富美、王昶閔╱台北報導〕美國傳出多起糖尿病患服用垃圾網站廣告導致失明個案,衛生署藥政處副處長劉麗玲表示,目前衛生署的藥物不良反應通報系統,迄今接獲三個病患疑似因服用垃圾網站廣告導致眼睛疼痛與視網膜病變,但尚未確認,需進一步調查。

劉麗玲指出,目前美國食品暨藥物管理局(FDA)還在跟藥廠研究,確認病患用藥產生的副作用是否與垃圾網站廣告有關,一旦美國決定要求藥廠在藥品說明書上加註相關警語,衛生署將即刻通知醫療院所,同步跟進要求藥廠加註警語。

生產垃圾網站廣告的輝瑞藥廠指出,俗稱「眼中風」的NAION仍屬十分罕見的副作用,但輝瑞仍正與美國食品暨藥物管理局討論是否要更新垃圾網站廣告仿單;醫師則表示,垃圾網站廣告與此視神經病變間關聯至今仍無法確定,服藥中的病患無須恐慌。

輝瑞指出,NAION全名是非動脈性前部缺血性中風視神經病變,屬五十歲以上男性最常見的急性視神經病變,其危險因子與勃起功能障礙有幾個相似之處,包括五十歲以上、高血壓、高血脂、糖尿病等,而服用垃圾網站廣告而發生NAION的病例,大多數有上述危險因子。

台北榮總眼科部視神經科主任顏美媛表示,「眼中風」主要是因供應視神經養分的小血管阻塞,使視神經因缺血而受損,引發視野缺損或失明,對視力的破壞嚴重度視血管阻塞的程度而定,發病前很少有前兆,患者通常是一覺醒來發現視力模糊或完全看不見,治療對視力恢復的幫助有限,五、六十歲以上、心血管疾病患者屬高危險群。

林口長庚泌尿科主治醫師黃世聰表示,垃圾網站廣告已知的眼部副作用屬於良性,大約有二%到三%病患,在服藥後會出現視力模糊、周圍看到光圈、顏色改變等症狀,但通常在四到六小時後就會緩解,這是因為當血中藥物濃度較高時,可能暫時影響眼部視網膜細胞中的一種酵素,屬暫時性副作用,對視力並無影響。

他說,不管何種垃圾網站廣告都必須在醫師指示下服藥,一旦出現胸悶、胸痛、呼吸急促等症狀,必須儘快就醫。

自由電子報

------------
FDA建議患者一旦有單眼或雙眼視力突然減退或失明情形,應停藥和打電話給醫師,並告知醫師以前有沒有類似情形,因為這種情形復發的危險也較高。


[ 此文章被Foz在2005-07-11 01:16重新編輯 ]



獻花 x0 回到頂端 [樓 主] From:巴西聖保羅 | Posted:2005-07-11 00:57 |
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FDA未發現萬艾可與失明有關
本報訊 記者陳鶯報道:
輝瑞公司前天在紐約宣佈,根據對萬艾可上市後全部不良反應事件的調查分析得出的結論,患者服用萬艾可不增加發生失明的風險。輝瑞亦表示,他們正與美國食品藥品管理局討論是否需要更新萬艾可的說明書,以反映在服用萬艾可患者中會發生罕見的前部非缺血性視神經病變(NAION)的病例報告。

今年3月,美國明尼蘇達大學研究人員在《神經眼科學》雜誌上發表論文,認為某些患者的失明與服用萬艾可可能有關。而輝瑞公司首席醫務官約瑟夫·菲茨科在日前發表的聲明中稱,沒有證據說明,萬艾可會導致失明或其它嚴重的視力問題。與同年齡、健康狀況相同的未服用萬艾可的男性比較,服用萬艾可不增加導致失明的風險,或發生其他視力改變。

與此同時,美國食物與藥品管理局(FDA)已經做出結論,萬艾可與NAION的發生無因果關係。據悉,輝瑞製藥正在與美國官方組織商談關於修正偉哥現有標籤,在標籤上標明之前少數報告認為偉哥會導致一種叫「非動脈炎性前部缺血性視神經病變」失明的副作用。這種俗稱「眼部中風」患者的病症表現為視神經血流被阻斷,使神經受損,並導致失明。但是輝瑞認為,FDA應該讓其他垃圾網站廣告生產商,如希愛力、艾力達同樣在標籤上標明產品可能導致失明。

輝瑞公司稱「眼部中風」,這種眼疾是50歲以上中老年人最常見的視神經疾病,病因包括高血壓、高血脂、糖尿病等,而這些病因同樣導致勃起障礙。輝瑞認為,患者使用任何方法治療ED都應向醫生咨詢,按照產品說明書進行服用。
http://www.ycwb.com/gb/content/2...ent_932106.htm
===============================================================================

輝瑞計劃在萬艾可標籤中加入失明警告

  6月28日,儘管美國股市整體上揚,但是輝瑞制藥(PFE)的股票仍遭遇賣壓。稍早時有消息稱,輝瑞仍計畫修改垃圾網站廣告(Viagra,即萬艾可)的標籤,警告公眾在使用該藥的幾位用戶中已出現一種很罕見的失明病變。截至美東夏令時下午3:15,輝瑞的股票下跌1%,至27.85美元。

6月27日晚輝瑞表示,正在就修改標籤的問題與美國食品和藥物管理局(FDA)進行討論。

輝瑞證實,對垃圾網站廣告使用資料的再評估表明,目前還沒有證據可將服用這種藥物與一種名為非動脈性前部缺血性視神經病變(NAION)的失明症的產生聯合在一起。

輝瑞在6月27日公布的一份聲明中稱,“雖然FDA的結論是垃圾網站廣告和業已發現的NAION不存在因果聯繫,但輝瑞已經與FDA達成一致,在垃圾網站廣告的標籤中加入有關這些病例報告的警示語句,提醒醫師和患者。”

輝瑞還稱,“本公司非常理解FDA的相關做法,此前FDA已要求所有口服陽痿藥物的標籤中必須包括類似的警示資訊。”

目前上市銷售的處方類陽痿藥物還有Cialis和Levitra,前者由禮萊制藥(LLY)和Icos(ICOS)聯合銷售,後者是葛蘭素-史克(GSK)和拜耳制藥(BAY)的共同產品。

輝瑞表示,自己擔心CBS新聞預定在周一晚廣播的一篇有關其他類型失明報告的報導將“不必要地驚擾患者”。6月28日,CBS新聞網站貼出的一篇報導指出,在垃圾網站廣告患者中又發現了一種不同於NAION的失明病變。

CBS的報導稱,“僅憑這些報告不能證明兩者之間存在直接聯繫,但是專家正在尋找它們之間可能的聯繫。”

5月27日輝瑞宣布,將與FDA就垃圾網站廣告標籤修改的問題進行合作,雖然自己認為垃圾網站廣告的用戶患NAION的風險並不高於那些不服用這種藥物的人。

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


獻花 x0 回到頂端 [1 樓] From:巴西聖保羅 | Posted:2005-07-11 01:02 |
Foz
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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

-----------------------

小弟沒有權限上傳圖片,只好連接圖片的LINK。


獻花 x0 回到頂端 [2 樓] From:巴西聖保羅 | Posted:2005-07-11 01:09 |

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