用藥亮紅燈！台灣准用92項抗生素 美FDA示警恐損傷神經

[chienchun]

用藥亮紅燈！台灣准用92項抗生素　美FDA示警恐損傷神經
NOWnews – 2013年9月24日 下午5:19
記者陳鈞凱／台北報導
民眾用藥要當心！美國FDA近期針對含「fluoroquinolone」類抗生素的口服或注射劑型藥品，發出用藥安全警訊，可能有發生罕見但永久性神經損傷的風險。衛生福利部今（24）天表示，這一大類抗生素屬於老藥，在國內共有6大類、92項藥品核准上市，由於上市前審核都「己知有這項風險」，目前仿單皆加註警語。
美國食品藥物管理局（FDA）是在近期發布有關含「fluoroquinolone」類抗生素，包括：levofloxacin、ciprofloxacin、moxifloxacin、norfloxacin、ofloxacin、gemifloxacin等成分口服或注射劑型藥品的用藥安全警訊，說明使用該類藥品可能有發生罕見但永久性神經損傷風險，並要求藥品仿單應加註相關內容。
這是已知的風險，衛生福利部食品藥物管理署藥品組科長陳可欣表示，經查目前國內共核准有6大類藥品、一共92張藥證，臨床使用廣泛，包括肺炎、泌尿道以及皮膚感染，都有可能用到該類成分藥品。
不過，由於這類藥品申請上市之前，已知有造成神經損傷的風險，也都有檢附相關風險評估，因此，目前所有藥品的仿單都已加註警語，再加上屬於醫師處方用藥，有醫師負責第一線把關，食藥署認為，沒必要採取額外動作。
陳可欣說，只要民眾出現感覺異常、感覺遲鈍及感覺減退，以及疼痛、燒灼感、刺痛感、麻痺或虛弱感等神經病變的症狀，一定要立即就醫、馬上告知主治醫師，進一步評估用藥安全。
食藥署強調，國內迄今並未接獲該類成分藥品異常的不良通報，但將持續密切監控，必要時，也不排除針對該類抗生素藥品啟動安全性再評估機制。提醒醫療人員或病人，發現懷疑因使用藥品發生不良反應時，立即通報全國藥物不良反應通報中心：藥物不良反應通報專線02-2396-0100，網站（http://www.fda.gov.tw）。
http://tw.news.yahoo.com/%E7%94%A8%E8%9 ... 57646.html

[truelovecoco]

ofloxacin是ENT超級指定愛用藥
五雷轟頂就更不用說了
用這麼久也沒看到啥大問題?

[Einstein]

這是早就知道的事，只是發生在罕見體質

[李誠民]

專利權早消失,中國大陸與印度應該有許多藥廠生產(應屬generic drugs),FDA-tw照樣監控就好,便宜又好用,為甚麼不使用?!

[李誠民]

http://articles.mercola.com/sites/artic ... otics.aspx
Big parmarcy 操作手法!!!

Dr. Mercola


The US Food and Drug Administration (FDA) recently issued a warning that fluoroquinolone antibiotics, taken by mouth or injection, carry a risk for permanent peripheral neuropathy. The safety announcement states:1


“The U.S. Food and Drug Administration (FDA) has required the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be updated to better describe the serious side effect of peripheral neuropathy.


This serious nerve damage potentially caused by fluoroquinolones may occur soon after these drugs are taken and may be permanent... The topical formulations of fluoroquinolones, applied to the ears or eyes, are not known to be associated with this risk.

Peripheral neuropathy is nerve damage in the arms and/or legs, characterized by “pain, burning, tingling, numbness, weakness, or a change in sensation to light touch, pain or temperature, or sense of body position.”

......This is not the first warning FDA has posted about this family of antibacterial drugs. In 2008, they posted a black box warning about severe tendon damage. Now having the additional warning for severe and sometimes-permanent nerve damage, there should be NO question in your mind about the danger of these drugs, and I strongly recommend avoiding them if at all possible.
.....
US FDA recently issued a warning that fluoroquinolone antibiotics, taken by mouth or injection, carry a risk for permanent peripheral neuropathy; Cipro (ciprofloxacin) and Levaquin (levofloxacin) are examples
This is not the first warning issued for this class of antibiotics; in 2008 the FDA issued a black box warning about severe tendon damage and actual tendon ruptures
Two other recent studies found that fluoroquinolones increase your risk for acute liver toxicity (if you’re over age 66), and destabilize your blood sugar if you’re diabetic
Fluoroquinolones have also been associated with memory loss, psychosis, headaches, depression, anxiety, kidney failure, cardiovascular symptoms, nausea and vomiting, blindness and other health problems
Fluoroquinolones are antibiotics with an attached fluoride molecule, which gives them the ability to penetrate into sensitive tissues like your brain and central nervous system, where they can exert neurotoxic effects
各自解讀!!!!

[DXE19]

levofloxacin是 老藥?

[cylindroma]

過專利期，有台廠的都是超過十年(?)的老藥吧...