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The author:(作者)delvpublished in(发表于) 2014/1/27 8:55:47 Food and Drug Administration： did not find hepatic injury induced by cold medicine to highlight risks
Website Shanghai January 26 new media allies ("China network thing" reporter Zhong Quan Cheng Zhoulin) on acetyl amino phenol (APAP) is cold drug common ingredients, but recently United States food drug regulatory Council (FDA) published statement, recommends medical personnel stopped issued the ingredients content each units dose over 325mg of compound prescription drug, "excessive taking on acetyl amino phenol can led to liver function failure, serious who needs liver transplant, even will led to death".
Subsequently, the media revelations of domestic sales of the new Contac, hundreds take strychnine content of 500 mg of acetaminophen. This message is raising concern among a lot of cold sufferers, some netizens said, cold, if not eaten anything.
Domestic cold medicine exists to highlight risks? How to read the United States FDA report? "China's Site," this reporter conducted an investigation.
Drug firms: acetaminophen which can effectively treat pain and fever, and long-term safe use
The new Contac manufacturer Glaxo Smith Kline (China) Investment Corporation provided a statement to reporters, acetaminophen is now widely used in prescription drugs and paracetamol such over-the-counter drugs (OTC for short). As long as the right to comply with the instructions described, acetaminophen is the active ingredient of treating pain and fever, and have a long safety record.
According to the statement, United States food and Drug Administration restrictions on the use of recommended only for prescription drugs and are not specific to ordinary people can be in the form of non-prescription drug products. Is the new Contac OTC category (hongzhuang) each tablet contains paracetamol 500 mg recommended daily dose of four tablets, the recommended dosage in line with China's food and drug administration 2000 mg per day the maximum amount of standards.
It is understood that United States standards the maximum amount per day of acetaminophen is 4,000 milligrams, much higher than China's standards.
It is worth mentioning that, United States FDA reports that, due to the acetaminophen is widely used in various types of prescription and over-the-counter drugs, many consumers are often not aware of this, so easy in unintended and excessive use of medicines contain the ingredients.
State food and drug supervision Administration: no prominent discovered the drug causes severe liver injury risk
26th response to the State food and drug supervision Administration said National Center for adverse drug reaction monitoring everyday monitoring found no use of paracetamol drugs led to highlight the risk of serious liver injury.
According to the responses, paracetamol liver damage is a known adverse reactions, overdose, long-term medication and would increase the risk of liver damage while taking the drinking. State Food Drug Administration reminds the public that the reading drug directions carefully, in accordance with the prescribed dosage to take the cold medicine, do not take several medicines containing acetaminophen while taking not to drink alcohol.
Shanghai food and Drug Administration drug registration Department official says, can be bought on the market contain acetaminophen formulations, are in line with national standards. Drug registration in China and comprehensive utilization of expert assessment, human experimentation, and other means of ensuring the safety of drugs all to fully guarantee the safety and effectiveness of drugs, substandard products pass the registration.
Expert: "us version" mainly for prescription drugs down retail sales
It is understood that the prescription drugs taken to strictly follow the doctor's orders. Beijing United family hospitals said Ji Lianmei, Director of pharmacy, in the United States, selling of retail prescription drugs is split, giving patients the drug should be placed in a small package, after leaving the original packaging of medicines, may not indicate the full name, this drug may cause the patient to repeat result in excess. The limit is designed to mitigate this risk.
Ji Lianmei said acetaminophen caused liver damage mainly due to repeated drug use, overdose and drinking while taking the medication. Some non-prescription drugs, although single tablets of 500mg, as specified in the instructions given, is safe.
Experts believe that a lot of people don't read United States FDA report, go out, misunderstood the meaning for some.
China Western Sichuan University Professor Zheng Xu believes that common colds should not use antibiotics, nor should infusion (hanging water), add the antibiotics. "The common cold is healing disease, you are not required to medication, drink more water rest is enough. Using cold medicines just alleviate the symptoms, makes people feel better. ”
Ji Lianmei tips, contain the same active ingredients, eat cold medicine to cure similar symptoms do not mix, otherwise it is easy to overdose and poisoning caused by repeated drug use similar ingredients.
新华网上海1月26日新媒体专电（“中国网事”记者钟泉盛 周琳）对乙酰氨基酚（ＡＰＡＰ）是感冒药常用成分，但近日美国食品药品监管局（ＦＤＡ）发表声明，建议医务人员停止开具该成分含量每单位剂量超过325ｍｇ的复方处方药物，“过量服用对乙酰氨基酚可导致肝功能衰竭，严重者需要肝移植，甚至会导致死亡”。
随后，有媒体曝出国内销售的新康泰克、百服宁等对乙酰氨基酚的含量为500毫克。这一消息引发不少感冒患者的担忧，有网民表示，感冒都不知道该吃什么药了。
国内相关感冒药是否存在突出风险？如何解读美国ＦＤＡ的报告？“中国网事”记者就此进行了调查。
药企：对乙酰氨基酚可有效治疗疼痛和发烧，并长期安全使用
新康泰克的生产商葛兰素史克（中国）投资有限公司向记者提供了一份声明称，目前对乙酰氨基酚被广泛应用于处方药和解热镇痛类的非处方药（简称ＯＴＣ）产品中。只要正确遵从说明书的介绍，对乙酰氨基酚是治疗疼痛和发烧的有效成分，并拥有长期安全使用的记录。
该声明称，美国食药监局的限制使用建议只针对处方药，并不针对普通民众可以在药店购买的非处方药产品。属非处方药范畴的新康泰克（红装）每片含有对乙酰氨基酚500毫克，建议每天服用四片，其建议用量符合中国食品药品监督管理局每天2000毫克最大量的标准。
据了解，美国每天服用对乙酰氨基酚的最大量标准为4000毫克，远高于中国的标准。
值得一提的是，美国ＦＤＡ的报告指出，由于对乙酰氨基酚在各类处方及非处方药物中被广泛应用，许多消费者通常不了解这个情况，因此容易在无意识的情况下过度服用包含该成分药物。
国家食药监管总局：未发现该药物存在导致严重肝损伤的突出风险
国家食药监管总局26日回应称，国家药品不良反应监测中心日常监测未发现使用含对乙酰氨基酚药品存在导致严重肝损伤的突出风险。
根据回应，肝损伤是对乙酰氨基酚的已知不良反应，过量使用、长期用药和用药期间饮酒会增加其肝损伤风险。国家食药监总局提醒公众，仔细阅读药品说明书，按规定的用法用量服用感冒药，不要同时服用多种含对乙酰氨基酚的药品，用药期间不要饮酒。
上海食药监局药品注册处相关负责人说，市场上能买到的各种含对乙酰氨基酚制剂，都是符合国家标准的。我国药品注册过程中，会综合利用专家评审、人体实验等保障药物安全的所有手段，充分保障药品的安全和有效性，不符合标准的产品通不过注册。
专家：“美版”规定主要针对处方药拆零售卖
据了解，处方药应严格按照医嘱服用。北京和睦家康复医院药房主任冀连梅说，在美国，处方药会拆零售卖，给患者的药需要放到小包装中，药品离开原始包装后，可能没有写明全称，这就导致患者可能重复用药导致超量。此次限定就是为了降低上述风险。
冀连梅说，对乙酰氨基酚造成肝损伤的主要原因是重复用药、超剂量用药和用药期间饮酒。一些非处方药，虽然单片含量为500ｍｇ，但按说明书服用，是安全的。
专家认为，不少人没有完整阅读美国ＦＤＡ的报告，难免出现断章取义的情况，对一些含义出现误读。
四川大学华西药学院教授徐正认为，普通感冒不应使用抗生素，更不应输液（吊水）注入抗生素。“普通感冒是自愈性的疾病，并非必须药物治疗，多喝开水注意休息足矣。用感冒药只是缓解症状，使人舒服一些。”
冀连梅提示，含有相同有效成分、治疗相同症状的感冒药不要混着吃，否则就会容易因重复用药导致同类成分过量而中毒。
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