[情報] 普拿疼acetaminophen止痛藥在美國恐下市

看板pharmacist (藥學生/藥師)作者danagmwad (醜胖集一身)時間16年前 (2009/07/02 00:36)推噓11(12推 1噓 8→)

留言21則, 12人參與討論串1/1

相關討論：http://www.plurk.com/p/15omen http://udn.com/NEWS/WORLD/WOR6/4993932.shtml 【世界日報╱美聯社馬里蘭州亞達斐1日電】 2009.07.01 09:04 pm 政府專家30日表示，包括Vicodin和Percocet等含有普拿疼(acetaminophen)與麻醉劑的處方藥應該下市，因服用過量可能導致死亡。食品暨藥物管理局(FDA)委員會的專家以20票對17票支持該決定。普拿疼是美國使用最廣的止痛藥物，許多病人因為普拿疼比較不傷胃，所以避免服用可能導致胃潰瘍的ibuprofen或aspirin(阿斯匹靈)，而選用普拿疼。食藥局表示，儘管多年來進行教育宣導，服用普拿疼過量是造成肝衰竭的主要原因，導致每年有5萬6000人進入急診室。普拿疼造成的60%死亡與處方藥物有關。不過許多專家也反對把這類止痛藥全面撤架，因為此種產品被廣泛用來控制嚴重慢性疼痛。食藥局專家以36票對1票決定，如果該類藥品不下市，該類藥品的標籤上應該以黑盒子 (black box)標示，警告該類藥品服用過量的危險。黑盒子是最嚴重的安全警告。根據食藥局的數據，去年開具2億張普拿疼處方。食藥局專家也以21票對16票決定，支持降低不需處方的普拿疼成藥每日最高服用量。目前的每日最高用量為四克，或是八粒Extra Strength Tylenol。該組專家沒有提出替代性的最高服用量。普拿疼是許多市售止痛藥成藥的主要成分，這些止痛藥包括Tylenol、 Excedrin和其他止痛藥。該組專家也以24票對13票贊成降低單次服用最高量到650毫克(650mg)。目前最高單次服用量為1000mg或兩粒Extra Strength Tylenol。食藥局專家在另一項表決中，決定1000mg的服用量，必須由醫師開具處方。【2009/07/01 世界日報】@ http://udn.com/ ============================================================================== http://www.msnbc.msn.com/id/31664450/ns/health-more_health_news/ FDA panel votes to eliminate Vicodin, Percocet Deadly overdoses of acetaminophen, narcotics are cited in recommendation ADELPHI, Md. - Government experts say prescription drugs like Vicodin and Percocet that combine a popular painkiller with stronger narcotics should be eliminated because of their role in deadly overdoses. A Food and Drug Administration panel on Tuesday voted 20-17 that prescription drugs that combine acetaminophen with other painkilling ingredients should be pulled off the market. The FDA has assembled a group of experts to vote on ways to reduce liver damage associated with acetaminophen, one of the most widely used drugs in the U.S. Despite years of educational campaigns and other federal actions, acetaminophen remains the leading cause of liver failure in the U.S., according to the FDA. Panelists cited FDA data indicating 60 percent of acetaminophen-related deaths are related to prescription products. Acetaminophen is also found in popular over-the-counter medications like Tylenol and Excedrin. “We’re here because there are inadvertent overdoses with this drug that are fatal and this is the one opportunity we have to do something that will have a big impact,” said Dr. Judith Kramer of Duke University Medical Center. Many opposed to recommendation But many panelists opposed a sweeping withdraw of products that are so widely used to control severe, chronic pain. “To make this shift without very clear understanding of the implications on the management of pain would be a huge mistake,” said Dr. Robert Kerns of Yale University. In a separate vote, the panel voted overwhelmingly, 36-1, that if the drugs stay on the market they should carry a black box warning, the most serious safety label available. The FDA is not required to follow the advice of its panels, though it usually does. Prescription acetaminophen combination drugs were prescribed 200 million times last year, according to FDA data. Vicodin is marketed by Abbott Laboratories, while Percocet is marketed by Endo Pharmaceuticals. Both painkillers also are available in cheaper generic versions. The FDA convened the two-day meeting to ask experts to discuss and vote on a slew of proposals to reduce overdoses with acetaminophen. The drug has been on the market for about 50 years and many patients find it easier on the stomach than ibuprofen and aspirin, which can cause ulcers. Panel voted to lower maximum acetaminophen dose Earlier in the day, panelists took aim at safety problems with Tylenol and dozens of other over-the-counter painkillers. In a series of votes, the panel endorsed lowering the maximum dose of those products. FDA’s experts voted 21-16 to lower the current maximum daily dose of nonprescription acetaminophen, which is 4 grams, or eight pills of a medication like Extra Strength Tylenol. The group was not asked to recommend an alternative maximum daily dose. The panel also voted 24-13 to limit the maximum single dose of the drug to 650 milligrams. The current single dose of Johnson & Johnson’s Extra Strength Tylenol is 1,000 milligrams, or two tablets. In a third vote, a majority of panelists said the 1,000-milligram dose should only be available by prescription. However, panelists rejected a proposal to pull certain cold and cough medicines off the market because of their role in overdosing. The drugs in question, such as Procter & Gamble’s NyQuil or Novartis’ Theraflu, combine acetaminophen with other ingredients that treat cough and runny nose. The FDA says patients often pair the cold medications with pure acetaminophen drugs, like Tylenol, exposing themselves to unsafe levels of the drug. But panelists cited FDA data that said the medications play a minor role in acetaminophen overdoses, with only 10 percent of acetaminophen-related deaths involving a cold and cough product. “I don’t think we should be advocating a solution to a problem that really is not there,” said Dr. Osemwota Omoigui, of the Los Angeles pain clinic. The panel voted 24-13 to keep the products on the market. -- 。 //* 請叫我偉大的西施女王Kitty大小姐喔呵呵呵～＊ ┌ ╭─┤╭─╮╭─╮╭─╮╭─╮╭┬╮╭ ╮╭─╮╭─┤ ┐ │ │ ││ ││ ││ ││╭╮│││││││ ││ │ │ └ ╰─╯╰─╰╰ ╯╰─╰╰─╯╰ ╯╰┴╯╰─╰╰─╯ ┘⊿ >///< Blog:http://angelch.twbbs.org/ Facebook:http://0rz.tw/JJEqm -- ※ 發信站: 批踢踢實業坊(ptt.cc) ◆ From: 114.47.45.187 ※ 編輯: danagmwad 來自: 114.47.45.187 (07/02 00:37)

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