相关讨论：http://www.plurk.com/p/15omen http://udn.com/NEWS/WORLD/WOR6/4993932.shtml 【世界日报╱美联社马里兰州亚达斐1日电】 2009.07.01 09:04 pm 政府专家30日表示，包括Vicodin和Percocet等含有普拿疼(acetaminophen)与麻醉剂的处 方药应该下市，因服用过量可能导致死亡。食品暨药物管理局(FDA)委员会的专家以20票 对17票支持该决定。 普拿疼是美国使用最广的止痛药物，许多病人因为普拿疼比较不伤胃，所以避免服用可能 导致胃溃疡的ibuprofen或aspirin(阿斯匹灵)，而选用普拿疼。食药局表示，尽管多年来 进行教育宣导，服用普拿疼过量是造成肝衰竭的主要原因，导致每年有5万6000人进入急 诊室。普拿疼造成的60%死亡与处方药物有关。 不过许多专家也反对把这类止痛药全面撤架，因为此种产品被广泛用来控制严重慢性疼痛 。 食药局专家以36票对1票决定，如果该类药品不下市，该类药品的标签上应该以黑盒子 (black box)标示，警告该类药品服用过量的危险。黑盒子是最严重的安全警告。根据食 药局的数据，去年开具2亿张普拿疼处方。 食药局专家也以21票对16票决定，支持降低不需处方的普拿疼成药每日最高服用量。 目前的每日最高用量为四克，或是八粒Extra Strength Tylenol。该组专家没有提出替代 性的最高服用量。普拿疼是许多市售止痛药成药的主要成分，这些止痛药包括Tylenol、 Excedrin和其他止痛药。 该组专家也以24票对13票赞成降低单次服用最高量到650毫克(650mg)。目前最高单次服用 量为1000mg或两粒Extra Strength Tylenol。食药局专家在另一项表决中，决定1000mg的 服用量，必须由医师开具处方。 【2009/07/01 世界日报】@ 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. -- 。 //* 请叫我伟大的西施女王Kitty大小姐喔呵呵呵～＊ ┌ ╭─┤╭─╮╭─╮╭─╮╭─╮╭┬╮╭ ╮╭─╮╭─┤ ┐ │ │ ││ ││ ││ ││╭╮│││││││ ││ │ │ └ ╰─╯╰─╰╰ ╯╰─╰╰─╯╰ ╯╰┴╯╰─╰╰─╯ ┘⊿ >///< Blog:http://angelch.twbbs.org/ Facebook:http://0rz.tw/JJEqm --

※ 发信站: 批踢踢实业坊(ptt.cc) ◆ From: 114.47.45.187 ※ 编辑: danagmwad 来自: 114.47.45.187 (07/02 00:37) ※ scorpiotiger:转录至看板 TMU943 07/02 11:30