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U.S. panel says data support cold medicines
SILVER SPRING, Maryland (Reuters) - Over-the-counter cold medicines made with phenylephrine appear effective for relieving nasal congestion in adults but the ingredient needs more study, a U.S. advisory panel said on Friday.
Phenylephrine was substituted for pseudoephedrine in many nonprescription cold and allergy medicines, including Johnson & Johnson's Sudafed PE, after the latter ingredient was restricted amid reports of abuse.
Researchers petitioned the government, however, saying there was no evidence phenylephrine worked for relieving a stuffy nose. The Food and Drug Administration asked a panel of outside experts to weigh in.
By an 11-1 vote, the committee said available data was \"supportive\" of the effectiveness of phenylephrine at 10 milligrams, the dose sold over the counter. Members also called for new and larger studies of that dose, mainly because available data came from small studies.
\"The evidence is not conclusive,\" Dr. Mary Tinetti, the panel's chairwoman, told reporters after the meeting.
The committee, in a 9-3 vote, also urged new research to see if a higher 25-milligram dose worked and was safe.
FDA reviewers said seven of 14 studies found a 10-milligram dose of phenylephrine improved resistance inside the nose, a measurement once used to assess congestion. Much of the research on phenylephrine was done in the 1960s and 1970s.
\"Based on the science, which I think was solid but very narrow, we do have seven studies that show significant improvements,\" said panel member Ralph D'Agostino, a Boston University statistician.
Makers of phenylephrine products include J&J, Schering-Plough Corp and Merck & Co Inc.
The manufacturers said phenylephrine had been used safely and effectively by millions for 40 years. Consumers have taken more than 5 billion doses over the past decade, according to the Consumer Healthcare Products Association (CHPA), which represents over-the-counter drugmakers.
The industry will work with the FDA to \"add to the body of evidence for 10 milligrams,\" CHPA President Linda Suydam said.
There are no convincing data that a 25-milligram dose is necessary, CHPA said in a statement.
Phenylephrine's use increased after a 2005 law required that pseudoephedrine products be kept behind the pharmacy counter, a move meant to prevent illegal conversion of pseudoephedrine into the stimulant methamphetamine.
A petition filed with the FDA in February by University of Florida researchers argued that 10 milligrams of phenylephrine had not been proven any better than a placebo at easing nasal congestion. Some research suggested 25 milligrams would work, the petition said.
\"The data available do not support the conclusion that phenylephrine 10-milligrams is effective\" as an oral decongestant, Randy Hatton, a pharmacist at the University of Florida and one of the petitioners, told the advisory panel.
Friday's FDA panel considered only adult use of phenylephrine. The FDA is considering a previous panel recommendation that a variety of over-the-counter cough and cold medicines should not be given to children under 6 because evidence of a benefit is lacking.
http://www.reuters.com/article/healthNews/idUSWBT00807020071214
马里兰州银泉（路透社）－周五，美国食品与药物管理局（FDA）顾问小组声称：由去甲肾上腺素为主要成分的非处方感冒药在成人感冒缓解鼻塞症状方面有效。但去甲肾上腺素这一有效成分尚需进一步研究，。
在假麻黄碱类药物在药物滥用报告中被限制使用以后，去甲肾上腺素这一成分在很多非处方的感冒药和抗过敏药中替代了包括Johnson & Johnson's Sudafed PE公司的盐酸伪麻黄碱片在内的假麻黄碱类药物。
但是也有研究者们向政府提出反对意见，他们说，没有证据表明去甲肾上腺素对改善鼻塞有效。美国食品与药物管理局（FDA）要求组成除外这些专家外的专家小组。来评价之一反对意见。
美国食品与药物管理局（FDA）的顾问小组，在11：1的投票后，发表声明：目前可用于引证的证据支持10mg的去甲肾上腺素是有效的这一结果，10mg这一剂量也是目前贩售的剂量。但是小组成员们依然呼吁：对于这个剂量应该有更新以及更为大型的研究。因为目前可以引用的数据均来自小样本研究。
Mary Tinett医生在会后的记者会上对记者们透露：“证据并非是决定性的，”。Mary Tinett医生是美国食品与药物管理局（FDA）顾问小组的主席。
美国食品与药物管理局（FDA）顾问小组同时以9：3同意关于催促开展关于“25mg的大剂量去甲肾上腺素是否安全有效”新的研究的决议。
美国食品与药物管理局（FDA）的专家们说：14个研究中的7个研究发现，10mg的去甲肾上腺素能够改善鼻阻塞，（鼻阻塞是用于评价充血的一个测量指标）。但是大多数关于去甲肾上腺素的研究是在1960年代到1970年代中做的。
Ralph D'Agostino是来自波士顿大学的统计学家，也是这个小组的成员，他这样说“基于科学，我所想的是很肯定的，但是同时也是很狭窄的，我们确实有7个研究能够显示去甲肾上腺素有明显的改善。”
制造去甲肾上腺素的公司包括J&J公司，Schering-Plough公司，以及默克药业。
生产厂家说，去甲肾上腺素在过去的40年中，在数以百万计的人中安全并有效的使用。
根据消费者健康保健产品协会(CHPA)的资料：消费者们在过去的20年中，使用了多过50亿片的10mg去甲肾上腺素片。这个机构也代表了非处方药的制药者。
CHPA的主席Linda Suydam说：“公司将致力于让美国食品与药物管理局（FDA）“10mg是有效剂量的证据”， CHPA在声明中说，“因为目前没有确切的证据证明25mg的剂量是必须的。”
在2005年法律规定假麻黄碱药物依然需要处方销售后，去甲肾上腺素使用大大增加。这种转变意味着避免在刺激去氧麻黄碱方面的假麻黄碱药物法律转变。
周五，来自佛罗里达大学研究者也递交给美国食品与药物管理局（FDA）一份关于“10mg肾上腺素没有足够证据证明在减少鼻充血方面优于安慰剂”的不同意见的文件。
Randy Hatton博士对美国食品与药物管理局（FDA）这样说：“目前可以引用的数据并不支持10mg的肾上腺素作为口服减充血药是有效的这个结论。” Randy Hatton博士是佛罗里达大学的药理学家，也是这次递交反对意见的研究者之一。
周五，美国食品与药物管理局（FDA）小组考虑只有在成人中使用肾上腺素。美国食品与药物管理局（FDA）正在考虑先前关于很多种非处方的咳嗽和感冒药物由于缺少有利的证据不该在小于6岁的儿童中使用的小组推荐意见。 |
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发表于 2008-1-5 07:19:22